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• W2094749747 abstract "The kidneys play an important role in maintaining the acid-base balance, as they excrete hydrogen ions and regenerate bicarbonate, thereby regulating intra- as well as extracellular pH, which are vital for normal cell function. In patients with renal failure, the inability of the kidneys to excrete an excess of hydrogen ions results in metabolic acidosis due to retention of acid degradation products, which has a detrimental effect on protein as well as amino acid turnover and leads to hypercatabolism [1.Bergsstrom J. Metabolic acidosis and nutrition in dialysis patients.Blood Purif. 1995; 13: 361-367Crossref PubMed Scopus (25) Google Scholar]. In these patients, treatment with bicarbonate has been shown to improve nitrogen balance and decrease both whole body amino acid oxidation and protein degradation [2.Graham K.A. Reaich D. Channon S.M. et al.Correction of acidosis in hemodialysis decreases whole-body protein degradation.J Am Soc Nephrol. 1997; 8: 632-637PubMed Google Scholar]. Metabolic acidosis also negatively affects cardiac, as well as bone, function. Consequently, one of the most important objectives of any dialysis therapy, including peritoneal dialysis (PD), is to correct acidosis. The correction of acidosis in PD is generally more stable than what can be achieved with intermittent hemodialysis [3.Graham K.A. Hoenich N.A. Goodship T.H. Pre and interdialytic acid-base balance in hemodialysis patients.Int J Artif Organs. 2001; 24: 192-196PubMed Google Scholar], and this may be one of the most important advantages of PD compared to hemodialysis. Historically, bicarbonate was the first buffer used in PD to correct uremic acidosis. However, the use of this buffer was soon discontinued due to its poor stability in the PD solution [4.Hutchison A.J. Gokal R. Improved solutions for peritoneal dialysis: Physiological calcium solutions, osmotic agents and buffers.Kidney Int. 1992; 38: S153-159Google Scholar]. In a search for alternative buffering agents, bicarbonate was replaced by either lactate or acetate. Both buffers maintain effective acid-base balance as they react with hydrogen ions derived from carbonic acid, thereby regenerating bicarbonate. Acetate, however, was subsequently found to be associated with loss of ultrafiltration and sclerosing peritonitis [5.Slingeneyer A. Mion C. Mourad G. et al.Progressive sclerosing peritonitis: A late and severe complication of maintenance peritoneal dialysis.Trans Am Soc Artif Intern Organs. 1983; 29: 633-640PubMed Google Scholar]. Its use was abandoned in the 1980s, leaving lactate as the only buffer used in PD for many years. A high lactate concentration is required to correct acidosis and the solution must be formulated at low pH to prevent caramelization of glucose during routine heat sterilization. As a result, these solutions have the potential for impairing peritoneal function and cause infusion pain during dialysis [6.Mactier R.A. Sprosen T.S. Gokal R. et al.Bicarbonate and bicarbonate/lactate peritoneal dialysis solutions for the treatment of infusion pain.Kidney Int. 1998; 53: 1061-1067Abstract Full Text Full Text PDF PubMed Scopus (126) Google Scholar, 7.Topley N. In vitro biocompatibility of bicarbonate-based peritoneal dialysis solutions.Perit Dial Int. 1997; 17: 42-47PubMed Google Scholar]. Several solution components are thought to play a role in the modulation of peritoneal cell function, peritoneal host defense, and the development of structural alterations in the dialyzed peritoneal membrane. These factors include solution pH, lactate concentration, as well as the concentration of glucose and glucose degradation products (GDP) in the solution [8.Cancarini G.C. Faict D. De Vos C. et al.Clinical evaluation of a peritoneal dialysis solution with 33 mmol/L bicarbonate.Perit Dial Int. 1998; 18: 576-582PubMed Google Scholar]. Therefore, alternative solutions with a more physiologic buffer system would represent a major evolution in PD therapy. One alternative is to use the body's major natural buffer, bicarbonate. Because for acidosis correction, a supraphysiologic bicarbonate level would be necessary, this level would also be associated with a supranormal level of dissolved carbon dioxide (pCO2). Although the clinical impact of higher than physiologic levels of bicarbonate and pCO2 is unknown, recent evidence has indicated that elevated pCO2 levels may have undesired side effects [8.Cancarini G.C. Faict D. De Vos C. et al.Clinical evaluation of a peritoneal dialysis solution with 33 mmol/L bicarbonate.Perit Dial Int. 1998; 18: 576-582PubMed Google Scholar]. It was suggested, therefore, that a combination of a physiologic bicarbonate concentration (25 mmol/L) and a lower lactate concentration (15 mmol/L) (B/L 25/15 solution, registered as Physioneal®) might have the dual benefit of adequately correcting acidosis and improving the biocompatibility profile of the solution, and thus be preferred over a pure bicarbonate solution. The pCO2 of this B/L 25/15 formulation is at the physiologic level and is therefore considered safe [8.Cancarini G.C. Faict D. De Vos C. et al.Clinical evaluation of a peritoneal dialysis solution with 33 mmol/L bicarbonate.Perit Dial Int. 1998; 18: 576-582PubMed Google Scholar, 9.Coles G.A. Gokal R. Ogg C. et al.A randomized controlled trial of a bicarbonate- and a bicarbonate/lactate-containing dialysis solution in CAPD.Perit Dial Int. 1997; 17: 48-51PubMed Google Scholar, 10.Coles G.A. O'Donoghue D.J. Pritchard N. et al.A controlled trial of two bicarbonate-containing dialysis fluids for CAPD—Final report.Nephrol Dial Transplant. 1998; 13: 3165-3171Crossref PubMed Scopus (51) Google Scholar]. Indeed, in a comparison between a pure bicarbonate formulation (38 mmol/L) and the B/L 25/15 formulation was found to have superior effects, both in vitro, ex vivo [11.MacKenzie R.K. Holmes C.J. Moseley A. et al.Bicarbonate/lactate- and bicarbonate-buffered peritoneal dialysis fluids improve ex vivo peritoneal macrophage TNF-α secretion.J Am Soc Nephrol. 1998; 9: 1499-1506PubMed Google Scholar, 12.Topley N. Kaur D. Petersen M.M. et al.In vitro effects of bicarbonate and bicarbonate-lactate buffered peritoneal dialysis solutions on mesothelial and neutrophil function.J Am Soc Nephrol. 1996; 7: 218-224PubMed Google Scholar], as well as in a phase II clinical trial [9.Coles G.A. Gokal R. Ogg C. et al.A randomized controlled trial of a bicarbonate- and a bicarbonate/lactate-containing dialysis solution in CAPD.Perit Dial Int. 1997; 17: 48-51PubMed Google Scholar, 10.Coles G.A. O'Donoghue D.J. Pritchard N. et al.A controlled trial of two bicarbonate-containing dialysis fluids for CAPD—Final report.Nephrol Dial Transplant. 1998; 13: 3165-3171Crossref PubMed Scopus (51) Google Scholar]. The B/L solutions are contained in a two-chambered bag, which overcomes many of the problems associated with the use of pure bicarbonate or conventional lactate-buffered PD solutions. The primary advantages of the B/L solution are: (1) a physiologic pH and pCO2; (2) a buffer that is physiologic in nature and at a physiologic concentration; (3) reduced GDPs; and (4) reduced lactate concentration. Thus, the B/L solution represents an effective, safe, well-tolerated, and physiologically balanced alternative to conventional lactate-buffered PD solutions. Because there is now an increasing cumulative clinical experience with the use of B/L solutions, the aim of the present review is to summarize the findings of the most important clinical studies that provide support for the use of this alternative dialysis solution as a standard solution for PD treatment in the near future. Since the introduction of B/L solutions, increasing clinical experience has been accumulated, consisting of a wide variety of studies, from in vitro to ex vivo and in vivo studies, and randomized clinical trials to registry reports. In the following section, a summary of the most important clinical studies that analyzed this PD solution will be presented, concentrating on its effects on acid-basis status, fluid balance, small solute clearances, biocompatibility markers, and infusion pain. The last section of this review will provide an overview of the safety profile of the B/L solutions. There is a general consensus that low plasma bicarbonate levels should be avoided in dialysis patients. Indeed, acidosis is known to adversely affect protein metabolism in chronic uremic patients [2.Graham K.A. Reaich D. Channon S.M. et al.Correction of acidosis in hemodialysis decreases whole-body protein degradation.J Am Soc Nephrol. 1997; 8: 632-637PubMed Google Scholar]. In addition, observations from animal and clinical studies suggest that metabolic acidosis affects several organs and other physiologic functions, including a depression of cardiac function and stimulation of parathyroid hormone (PTH) activity [13.Stein A. Moorhouse J. Iles-Smith H. et al.Role of an improvement in acid-base status and nutrition in CAPD patients.Kidney Int. 1997; 52: 1089-1095Abstract Full Text PDF PubMed Scopus (156) Google Scholar]. It is recommended that every effort should be made to correct metabolic acidosis because this condition has been clearly proven to have a number of detrimental effects [13.Stein A. Moorhouse J. Iles-Smith H. et al.Role of an improvement in acid-base status and nutrition in CAPD patients.Kidney Int. 1997; 52: 1089-1095Abstract Full Text PDF PubMed Scopus (156) Google Scholar, 14.Walls J. Metabolic acidosis and uremia.Perit Dial Int. 1995; 15: S36-38PubMed Google Scholar]. Many physicians use the normal plasma bicarbonate range as a target, but higher levels achieved with the use of a 40 mmol/L compared to a 35 mmol/L lactate solution have been reported to improve the patient's nutritional state [14.Walls J. Metabolic acidosis and uremia.Perit Dial Int. 1995; 15: S36-38PubMed Google Scholar]. Indeed, it has been found that protein breakdown is reduced at bicarbonate values around 30 mmol/L [13.Stein A. Moorhouse J. Iles-Smith H. et al.Role of an improvement in acid-base status and nutrition in CAPD patients.Kidney Int. 1997; 52: 1089-1095Abstract Full Text PDF PubMed Scopus (156) Google Scholar, 14.Walls J. Metabolic acidosis and uremia.Perit Dial Int. 1995; 15: S36-38PubMed Google Scholar]. Overall, a plasma bicarbonate target in the high normal range appears desirable. From a theoretical point of view, alkalosis might be associated with adynamic bone disease and increased soft tissue calcification, but there are no clinical data in PD patients indicating that mild alkalosis would be associated with these effects. A total of 59 patients who had been treated by continuous ambulatory peritoneal dialysis (CAPD) for at least 3 months with a dialysis solution containing 40 mmol/L lactate were entered into a phase II parallel, randomized, open-label, controlled, prospective study [9.Coles G.A. Gokal R. Ogg C. et al.A randomized controlled trial of a bicarbonate- and a bicarbonate/lactate-containing dialysis solution in CAPD.Perit Dial Int. 1997; 17: 48-51PubMed Google Scholar, 10.Coles G.A. O'Donoghue D.J. Pritchard N. et al.A controlled trial of two bicarbonate-containing dialysis fluids for CAPD—Final report.Nephrol Dial Transplant. 1998; 13: 3165-3171Crossref PubMed Scopus (51) Google Scholar]. Patients were randomized to receive dialysis with B/L 25/15 solution (N = 20), a solution containing 38 mmol/L bicarbonate (N = 20), or a solution containing 40 mmol/L lactate (control, N = 19), and followed for 2 months with an optional 4-month extension. The primary efficacy variable was the effect on plasma bicarbonate as a measure of control of uremic acidosis. Acid-base status was assessed from venous blood samples. All 3 solutions effectively corrected acidosis. In the B/L 25/15 group, there was a transient rise (1.4 mmol/L, P < 0.05) in plasma bicarbonate level. Although statistically significant, this modest rise was regarded as clinically irrelevant. The reason for the slight rise in plasma bicarbonate is not known, but an appealing hypothesis is that in lactate-based solutions there is a small production of lactic acid, which occurs to a lesser degree when a B/L solution is used [15.Otte K. Gonzalez M.T. Bajo M.A. et al.Clinical experience with a new bicarbonate (25 mmol/L)/lactate (10 mmol/L) peritoneal dialysis solution.Perit Dial Int. 2003; 23: 138-145PubMed Google Scholar]. In addition, one may speculate that this rise in bicarbonate could reflect anabolism, resulting in less generation of acid, and this could in turn perhaps be due to a salutary effect on systemic inflammation, improved glycemic control, or both. In a phase III prospective, randomized, open-label, controlled, multicenter study, 106 PD patients were randomized in a 2:1 ratio to receive dialysis for 6 months with either B/L 25/15 (N = 70), or a standard lactate-based solution containing 40 mmol/L lactate (N = 36) [16.Tranaeus A. A long-term study of a bicarbonate/lactate-based peritoneal dialysis solution—Clinical benefits. The Bicarbonate/Lactate Study Group.Perit Dial Int. 2000; 20: 516-523Abstract Full Text Full Text PDF PubMed Scopus (154) Google Scholar]. At the end of the 6-month efficacy period, patients were invited to continue for an additional 6 months on the treatment to which they had been randomized, thus giving a full year on treatment. A total of 57 patients (43 B/L 25/15 solution and 14 control) continued into the extension phase. Although there was a statistically significant increase in plasma bicarbonate, this study showed that the B/L 25/15 solution was therapeutically equivalent to the standard lactate solution in terms of the primary efficacy end point (i.e., the control of uremic acidosis and the overall difference in plasma bicarbonate). In addition, patients on the B/L solutions reported improvements in nausea, appetite, fluid control, energy levels, calmness, and experienced a significant increase in body weight (approximately 1 kg, P < 0.05) by 6 months. This weight gain was sustained over the long term, potentially due to increased well-being resulting in increased appetite. The weight gain cannot be explained by fluid retention, because there was a slight increase in peritoneal net ultrafiltration in the B/L 25/15 group compared to the lactate group. Dratwa et al analyzed the same efficacy parameters in a recent study of patients on automated PD patients, and concluded that the advantages of B/L 25/15 can be extended to these patients [abstract; Dratwa M, Nephrol Dial Transplant 18:212, 2003]. Another randomized, parallel, controlled, open-label, multicenter study of CAPD patients compared the effects of the B/L 25/15 solution (N = 20) and a 35 mmol/L lactate solution (N = 11) on venous plasma bicarbonate level [17.Carrasco A.M. Rubio M.A. Sanchez Tommero J.A. et al.Acidosis correction with a new 25 mmol/l bicarbonate/15 mmol/l lactate peritoneal dialysis solution.Perit Dial Int. 2001; 21: 546-553PubMed Google Scholar]. The treatment period was 3 months. During a preceding 1-month baseline period and a post-study follow-up, all patients received the 35 mmol/L lactate solution. In patients dialyzed with B/L 25/15 solution, venous plasma bicarbonate rose by 3.1 mmol/L (CI, 1.6–4.8) from a baseline of 23.0 mmol/L (P < 0.05 vs. lactate solution). In addition, the number of acidotic patients (venous plasma bicarbonate <24 mmol/L) was significantly lower in the B/L 25/15 solution group compared to the lactate group at every treatment period visit. These results indicate that the B/L 15/25 solution provides improved control of acidosis compared with a 35 mmol/L lactate-buffered solution. Because the need for added buffer varies in the patient population, a new solution composed of 25 mmol/L bicarbonate and 10 mmol/L lactate (B/L 25/10; Physioneal® 35) was developed to increase therapy flexibility. Recently, Otte et al[15.Otte K. Gonzalez M.T. Bajo M.A. et al.Clinical experience with a new bicarbonate (25 mmol/L)/lactate (10 mmol/L) peritoneal dialysis solution.Perit Dial Int. 2003; 23: 138-145PubMed Google Scholar] reported the results of a Danish-Spanish prospective, open-label study that compared the B/L 25/10 solution with a standard 35 mmol/L lactate solution during an 8-week treatment period. In this study, all patients used a standard 35 mmol/L lactate solution during a 2-week baseline and a 2-week follow-up period. Venous plasma bicarbonate levels rose from 24.4 mmol/L when patients were on the pure lactate solution to 26.1 mmol/L when using the bicarbonate/lactate solution (P < 0.001). When patients were using the B/L 25/10 solution, 66% of the plasma bicarbonate values were maintained within the normal range of 24–30 mmol/L, compared with 46.2% of values when patients were on the pure lactate solution (P < 0.001). The authors concluded that the B/L 25/10 solution provided better correction of acidosis than an equivalent 35 mmol/L standard lactate solution. The phase III prospective, randomized, open-label, controlled, multicenter study that compared the efficacy of a B/L 25/15 solution with that of a standard lactate solution [16.Tranaeus A. A long-term study of a bicarbonate/lactate-based peritoneal dialysis solution—Clinical benefits. The Bicarbonate/Lactate Study Group.Perit Dial Int. 2000; 20: 516-523Abstract Full Text Full Text PDF PubMed Scopus (154) Google Scholar] also showed important results regarding other efficacy variables, such as 24-hour ultrafiltration and peritoneal urea and creatinine clearances. In the B/L 25/15 solution group, mean 24-hour ultrafiltration increased from baseline by 150 mL/day (P < 0.05), and 5 patients spontaneously reported improved ultrafiltration; no change in ultrafiltration was observed in the control group. The solutions were shown to be therapeutically equivalent with respect to peritoneal urea and creatinine clearances. Similarly, the efficacy of the B/L 25/10 solution was equivalent to that of a standard lactate solution with regard to the peritoneal equilibration test (PET) results, adequacy, and ultrafiltration [15.Otte K. Gonzalez M.T. Bajo M.A. et al.Clinical experience with a new bicarbonate (25 mmol/L)/lactate (10 mmol/L) peritoneal dialysis solution.Perit Dial Int. 2003; 23: 138-145PubMed Google Scholar]. The pain experienced by some patients during PD infusions has been attributed to the acidity of conventional dialysis solutions [6.Mactier R.A. Sprosen T.S. Gokal R. et al.Bicarbonate and bicarbonate/lactate peritoneal dialysis solutions for the treatment of infusion pain.Kidney Int. 1998; 53: 1061-1067Abstract Full Text Full Text PDF PubMed Scopus (126) Google Scholar]. Infusion pain is usually observed in new patients commencing dialysis and is often transient in nature, spontaneously disappearing over time. However, infusion pain can remain a troublesome complication in some PD patients, potentially interfering with compliance, and in the most extreme cases can result in the discontinuation of PD. The most common treatment to alleviate infusion pain is the neutralization of the PD solution by manual injection of sodium bicarbonate into the solution immediately prior to infusion. Although a number of reports have demonstrated the effectiveness of such manual injection in alleviating infusion pain [18.Bunchman T.E. Ballal S.H. Treatment of inflow pain by pH adjustment of dialysate in peritoneal dialysis.Perit Dial Int. 1991; 11: 179-180PubMed Google Scholar, 19.Yamamoto T. Sakakura T. Yamakawa M. et al.Clinical effects of long-term use of neutralized dialysate for continuous ambulatory peritoneal dialysis.Nephron. 1992; 60: 324-329Crossref PubMed Scopus (25) Google Scholar], the need to complete this procedure prior to every infusion adds to the therapy burden for the patient and also increases the overall cost of therapy. The greatest concern, however, is the increased risk of peritonitis due to potential external contamination of the solution. A randomized, double-blind, crossover study [6.Mactier R.A. Sprosen T.S. Gokal R. et al.Bicarbonate and bicarbonate/lactate peritoneal dialysis solutions for the treatment of infusion pain.Kidney Int. 1998; 53: 1061-1067Abstract Full Text Full Text PDF PubMed Scopus (126) Google Scholar] examined the effects of the B/L 25/15 solution, a pure bicarbonate (38 mmol/L) solution, and a 40 mmol/L lactate solution in 18 patients who had experienced repeated inflow pain with conventional lactate (40 mmol/L) solutions. Patients were evaluated during 2 dialysis exchanges with each test solution in random order over a period of 1 to 3 weeks (i.e., each patient was assessed on 6 occasions). A five-point verbal scale was used to assess pain intensity during the infusion, dwell, and drain phases. To assess inflow pain in a systematic way, patients completed the validated McGill Pain Questionnaire (MPQ) after 40 minutes of the dwell. The B/L 25/15 solution and the pure bicarbonate solution significantly reduced peak pain during infusion compared with the lactate solution (P = 0.001 for both solutions vs. lactate). Though not statistically significant, there was a trend for a lower pain score with the B/L 25/15 solution (peak pain response of 0.4) compared with pure bicarbonate (peak pain response of 0.6). In addition, the peak pain score during dwell and drain was significantly lower for B/L 25/15 compared with the bicarbonate solution. The MPQ produced similar results; the B/L 25/15 and the bicarbonate solutions produced significantly lower scores for the total weighted pain-rating index than the control lactate solution. Again, there was a trend for lower scores with B/L 25/15 than with bicarbonate. Infusion of the B/L 25/15 solution also was associated with significantly lower scores than infusion of lactate for the individual MPQ dimensions (affective, evaluative, sensory, miscellaneous), the number of words chosen (which assesses pain severity), and the present pain intensity. Importantly, for every single variable, mean scores were better with B/L 25/15 than with the pure bicarbonate solution. In a prospective randomized study comparing B/L 25/15 and conventional dialysis solutions, 40% of patients receiving B/L 25/15 reported less infusion pain/abdominal discomfort [16.Tranaeus A. A long-term study of a bicarbonate/lactate-based peritoneal dialysis solution—Clinical benefits. The Bicarbonate/Lactate Study Group.Perit Dial Int. 2000; 20: 516-523Abstract Full Text Full Text PDF PubMed Scopus (154) Google Scholar]. This percentage is substantially higher than reported earlier, suggesting that the frequency of abdominal symptoms to a large extent remains underestimated. In summary, bicarbonate-based, pH-neutral solutions are effective in reducing the intensity of pain experienced with the infusion of a conventional lactate solution. The B/L 25/15 solution appears to be the most effective in reducing inflow pain, possibly because of the additional benefit of a physiologic pCO2 compared with the pure bicarbonate solution. Reduction in inflow pain is a valuable clinical outcome as it has a favorable effect on quality of life and therefore may improve patient compliance. In addition, it indicates also improved biocompatibility. Preliminary findings from The European PD Solutions Registry (PDSR) showed that the B/L 25/15 solutions reduced the duration of peritonitis episodes [abstract; Van Bree M et al, J Am Soc Nephrol 13:43A, 2003], and significantly decreased the proportion of patients with peritonitis (21%) compared with lactate solutions (29%, P < 0.0005). The PDSR was initiated in November 1997 and is a prospective registry of patients (current cumulative total, 2313) treated with alternative PD solutions. These results may reflect a salutary effect on both local and systemic immune response. The phase II study described previously [9.Coles G.A. Gokal R. Ogg C. et al.A randomized controlled trial of a bicarbonate- and a bicarbonate/lactate-containing dialysis solution in CAPD.Perit Dial Int. 1997; 17: 48-51PubMed Google Scholar, 10.Coles G.A. O'Donoghue D.J. Pritchard N. et al.A controlled trial of two bicarbonate-containing dialysis fluids for CAPD—Final report.Nephrol Dial Transplant. 1998; 13: 3165-3171Crossref PubMed Scopus (51) Google Scholar] also assessed the safety of the B/L 25/15 solution in CAPD patients. The following safety parameters were assessed: peritoneal permeability (using the PET), dialysis adequacy, biochemical changes, and adverse events. Plasma bicarbonate levels were not influenced of transport status [10.Coles G.A. O'Donoghue D.J. Pritchard N. et al.A controlled trial of two bicarbonate-containing dialysis fluids for CAPD—Final report.Nephrol Dial Transplant. 1998; 13: 3165-3171Crossref PubMed Scopus (51) Google Scholar]. The analysis of the PET and clearances showed that none of the PD solutions had a major impact on membrane permeability and adequacy parameters, and renal function was unchanged over time. The most commonly reported adverse events (peritonitis, hypertension, hypercalcemia, and hyperphosphatemia) were not attributed to the test solutions. There were no statistically significant differences between the 2 groups with regard to the numbers of patients reporting each event. The phase III study [16.Tranaeus A. A long-term study of a bicarbonate/lactate-based peritoneal dialysis solution—Clinical benefits. The Bicarbonate/Lactate Study Group.Perit Dial Int. 2000; 20: 516-523Abstract Full Text Full Text PDF PubMed Scopus (154) Google Scholar] showed that safety parameters remained stable over the 1-year study period. Results from the UK/Italian multicenter study [10.Coles G.A. O'Donoghue D.J. Pritchard N. et al.A controlled trial of two bicarbonate-containing dialysis fluids for CAPD—Final report.Nephrol Dial Transplant. 1998; 13: 3165-3171Crossref PubMed Scopus (51) Google Scholar] also showed that patients on the B/L 25/15 solution presented no changes in blood biochemistry parameters measured in the PET or with regard to adequacy of dialysis, indicating that the solution was well tolerated. Surprisingly, in this study [10.Coles G.A. O'Donoghue D.J. Pritchard N. et al.A controlled trial of two bicarbonate-containing dialysis fluids for CAPD—Final report.Nephrol Dial Transplant. 1998; 13: 3165-3171Crossref PubMed Scopus (51) Google Scholar], calcium carbonate intake did not influence plasma bicarbonate levels. The new bicarbonate/lactate solutions could play an important role in achieving adequate acid basis status. Indeed, a recent clinical trial showed that the B/L 25/10 solution provided better correction of acidosis than an equivalent 35 mmol/L standard lactate solution, without any safety issues [15.Otte K. Gonzalez M.T. Bajo M.A. et al.Clinical experience with a new bicarbonate (25 mmol/L)/lactate (10 mmol/L) peritoneal dialysis solution.Perit Dial Int. 2003; 23: 138-145PubMed Google Scholar]. Nonetheless, the future option of a more individualized treatment of acidosis, using both a B/L 25/10 and a B/L 25/15 solution, may represent a therapeutic advantage. Another important issue was addressed by Williams et al[20.Williams P. Mariott J. Coles G. et al.Insulin efficacy with a new bicarbonate/lactate peritoneal dialysis solution.Perit Dial Int. 2000; 20: 467-469PubMed Google Scholar], who analyzed the effect of the B/L 25/15 solution and a standard 40 mmol/L lactate-buffered solution on the blood glucose response of 6 stable diabetic patients when a standard dose of insulin was added to the dialysis solution. The results showed that the blood glucose levels of the patients were similar for all 3 exchanges (lactate, B/L 25/15, lactate), and showed similar trends over time. Thus, neither the neutral pH nor the presence of bicarbonate appeared to influence the blood glucose levels of diabetic patients. This implies that the bioavailability of insulin and its adsorption onto the polyvinyl chloride (PVC) bag, are unchanged by any constituents in the B/L 25/15 solution. Therefore, it can be concluded that insulin can be added to the B/L 25/15 solution in the same way as for the standard lactate-based solutions. In vitro data clearly show the superiority of B/L 25/15 solutions in preserving leukocyte and mesothelial cell function compared with acidic lactate-buffered solutions [7.Topley N. In vitro biocompatibility of bicarbonate-based peritoneal dialysis solutions.Perit Dial Int. 1997; 17: 42-47PubMed Google Scholar]. The findings are consistent with ex vivo data from the phase II and III clinical trials, which demonstrated that patients dialyzed with solutions containing bicarbonate/lactate or pure bicarbonate have better-preserved peritoneal macrophage function [assessed by tumor necrosis factor α (TNFα) release], a marker of improved host defense status, than patients treated with traditional lactate-based solutions [11.MacKenzie R.K. Holmes C.J. Moseley A. et al.Bicarbonate/lactate- and bicarbonate-buffered peritoneal dialysis fluids improve ex vivo peritoneal macrophage TNF-α secretion.J Am Soc Nephrol. 1998; 9: 1499-1506PubMed Google Scholar, 21.Mackenzie R.K. Jones S. Moseley A. et al.In vivo exposure to bicarbonate/lactate- and bicarbonate-buffered peritoneal dialysis fluids improves ex vivo peritoneal macrophage function.Am J Kidney Dis. 2000; 35: 112-121Abstract Full Text Full Text PDF PubMed Scopus (43) Google Scholar]. Also, markers of peritoneal mesothelial cell mass and intraperitoneal inflammation have been assessed in patients treated continuously with either B/L 25/15 or standard solutions [23.Jones S. Holmes C.J. Krediet R.T. et al.Bicarbonate/lactate-based peritoneal dialysis solution increases cancer antigen 125 and decreases hyaluronic acid levels.Kidney Int. 2001; 59: 1529-1538Abstract Full Text Full Text PDF PubMed Scopus (160) Google Scholar, 24.Pecoits-Filho R. Barany P. Lindholm B. et al.Interleukin-6 is an independent predictor of mortality in patients starting dialysis treatment.Nephrol Dial Transplant. 2002; 17: 1684-1688Crossref PubMed Scopus (331) Google Scholar]. The results showed that when patients were dialyzed with B/L 25/15 solution, there was a statistically significant decrease in interleukin (IL)-6, and hyaluronic acid (HA), both markers of local inflammation. Given that intraperitoneal and systemic inflammation (a well established predictor of mortality in PD patients [24.Pecoits-Filho R. Barany P. Lindholm B. et al.Interleukin-6 is an independent predictor of mortality in patients starting dialysis treatment.Nephrol Dial Transplant. 2002; 17: 1684-1688Crossref PubMed Scopus (331) Google Scholar]) may be linked to each other [abstract; Pecoits-Filho R et al, J Am Soc Nephrol 13:42A, 2002], and that inflammation is known to be associated with changes in peritoneal membrane structure and function and therefore indirectly with outcome on dialysis, the reduction of inflammation could be of great significance in long-term PD. Bicarbonate/lactate-buffered PD solutions offer an effective, safe, well-tolerated, and physiologically balanced alternative to conventional lactate-buffered solutions. Moreover, these alternative solutions have proved to be more biocompatible based on several in vitro, ex vivo, and in vivo studies. Randomized clinical trials have demonstrated additional advantages including reduction in infusion pain, more efficient acid-base control, increased ultrafiltration, and reduced peritonitis duration, with equivalent peritoneal small solutes clearances and no changes in membrane transport parameters Table 1. Therefore, it can be concluded that consistent clinical data support the use of B/L solutions as the preferred dialysis fluids in future of PD, as their use may enhance the global (local plus systemic) biocompatibility. Future clinical trials will assess and quantify how these advantageous characteristics translate into improvements in patient and technique survival.Table 1Key differences between bicarbonate/lactate solutions and lactate-buffered solutions observed in clinical trialsCompositionPhysiologic pH, pCO2, and buffer; reduced GDP and lactate concentrationAdequacy parametersComparable 9.Coles G.A. Gokal R. Ogg C. et al.A randomized controlled trial of a bicarbonate- and a bicarbonate/lactate-containing dialysis solution in CAPD.Perit Dial Int. 1997; 17: 48-51PubMed Google Scholar, 10.Coles G.A. O'Donoghue D.J. Pritchard N. et al.A controlled trial of two bicarbonate-containing dialysis fluids for CAPD—Final report.Nephrol Dial Transplant. 1998; 13: 3165-3171Crossref PubMed Scopus (51) Google ScholarTransport parametersComparable 9.Coles G.A. Gokal R. Ogg C. et al.A randomized controlled trial of a bicarbonate- and a bicarbonate/lactate-containing dialysis solution in CAPD.Perit Dial Int. 1997; 17: 48-51PubMed Google Scholar, 10.Coles G.A. O'Donoghue D.J. Pritchard N. et al.A controlled trial of two bicarbonate-containing dialysis fluids for CAPD—Final report.Nephrol Dial Transplant. 1998; 13: 3165-3171Crossref PubMed Scopus (51) Google ScholarAdverse eventsComparable 9.Coles G.A. Gokal R. Ogg C. et al.A randomized controlled trial of a bicarbonate- and a bicarbonate/lactate-containing dialysis solution in CAPD.Perit Dial Int. 1997; 17: 48-51PubMed Google Scholar, 10.Coles G.A. O'Donoghue D.J. Pritchard N. et al.A controlled trial of two bicarbonate-containing dialysis fluids for CAPD—Final report.Nephrol Dial Transplant. 1998; 13: 3165-3171Crossref PubMed Scopus (51) Google Scholar, 16.Tranaeus A. A long-term study of a bicarbonate/lactate-based peritoneal dialysis solution—Clinical benefits. The Bicarbonate/Lactate Study Group.Perit Dial Int. 2000; 20: 516-523Abstract Full Text Full Text PDF PubMed Scopus (154) Google ScholarAcidosis correctionImproved 16.Tranaeus A. A long-term study of a bicarbonate/lactate-based peritoneal dialysis solution—Clinical benefits. The Bicarbonate/Lactate Study Group.Perit Dial Int. 2000; 20: 516-523Abstract Full Text Full Text PDF PubMed Scopus (154) Google ScholarBiocompatibility in vitroIncreased cell vitality 12.Topley N. Kaur D. Petersen M.M. et al.In vitro effects of bicarbonate and bicarbonate-lactate buffered peritoneal dialysis solutions on mesothelial and neutrophil function.J Am Soc Nephrol. 1996; 7: 218-224PubMed Google ScholarBiocompatibility in vivoIncrease in CA125 23.Jones S. Holmes C.J. Krediet R.T. et al.Bicarbonate/lactate-based peritoneal dialysis solution increases cancer antigen 125 and decreases hyaluronic acid levels.Kidney Int. 2001; 59: 1529-1538Abstract Full Text Full Text PDF PubMed Scopus (160) Google Scholar, decrease in IL-6 and VEGF 22.Cooker L.A. Luneburg P. Holmes C.J. et al.Interleukin-6 levels decrease in effluent from patients dialyzed with bicarbonate/lactate-based peritoneal dialysis solutions.Perit Dial Int. 2001; 21: S102-107PubMed Google Scholar, hyaluronan 23.Jones S. Holmes C.J. Krediet R.T. et al.Bicarbonate/lactate-based peritoneal dialysis solution increases cancer antigen 125 and decreases hyaluronic acid levels.Kidney Int. 2001; 59: 1529-1538Abstract Full Text Full Text PDF PubMed Scopus (160) Google ScholarUltrafiltrationEnhanced 16.Tranaeus A. A long-term study of a bicarbonate/lactate-based peritoneal dialysis solution—Clinical benefits. The Bicarbonate/Lactate Study Group.Perit Dial Int. 2000; 20: 516-523Abstract Full Text Full Text PDF PubMed Scopus (154) Google ScholarPeritonitisDecrease in duration and proportion of patients [abstract; Van Bree M, J Am SocNephrol 13:43A, 2003]Infusion painRelieved 6.Mactier R.A. Sprosen T.S. Gokal R. et al.Bicarbonate and bicarbonate/lactate peritoneal dialysis solutions for the treatment of infusion pain.Kidney Int. 1998; 53: 1061-1067Abstract Full Text Full Text PDF PubMed Scopus (126) Google ScholarNutritional statusImproved 16.Tranaeus A. A long-term study of a bicarbonate/lactate-based peritoneal dialysis solution—Clinical benefits. The Bicarbonate/Lactate Study Group.Perit Dial Int. 2000; 20: 516-523Abstract Full Text Full Text PDF PubMed Scopus (154) Google ScholarQuality of lifeImproved 15.Otte K. Gonzalez M.T. Bajo M.A. et al.Clinical experience with a new bicarbonate (25 mmol/L)/lactate (10 mmol/L) peritoneal dialysis solution.Perit Dial Int. 2003; 23: 138-145PubMed Google ScholarAbbreviations are: GDP, glucose degradation products; CA125, cancer antigen 125; IL-6, interleukin-6; VEGF, vascular endothelial growth factor. Open table in a new tab" @default.
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