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- W2922505549 abstract "Purpose: Aggressive fluid resuscitation is recommended for early management of acute pancreatitis (AP). Our aims were to 1) evaluate the impact of a goal-directed fluid resuscitation protocol vs. standard resuscitation on systemic inflammation and 2) evaluate impact of resuscitation with Lactated Ringer's (LR) versus normal saline (NS) on systemic inflammation during the initial 24 hours of hospitalization. Methods: Study design: open-label four-arm parallel group randomized-controlled trial. Study sites: Brigham and Women's Hospital, Boston MA, Faulkner Hospital, Jamaica Plain, MA and Dartmouth-Hitchcock Medical Center, Lebanon, NH. Study dates: May 2009-February 2010. Patients with major comorbid or concurrent illness that precluded aggressive fluid resuscitation were excluded. Subjects were enrolled within 6 hours of presentation and randomized to one of four treatment arms: 1) Goal-directed with LR, 2) Goal-directed with NS, 3) Standard with LR, or 4) Standard with NS. Subjects randomized to goal-directed resuscitation had rate of fluid administration adjusted every 8 hours by study investigators according to protocol. Primary outcome was point-prevalence of systemic inflammatory response syndrome (SIRS) at 24-hours post-randomization. Secondary outcome was C-reactive protein (CRP) level at 24-hours post-randomization. All data were analyzed on an intent-to-treat basis. Results: A total of 40 subjects were randomized and included in analysis. Aim 1: 19 subjects were randomized to goal-directed and 21 to standard fluid resuscitation. Total volume of fluid administered during the 24 hour intervention period was similar between treatment arms (mean 4,300 mL goal-directed vs. 4,600 mL standard, p=0.87). There was no difference with respect to prevalence of SIRS (11.8% goal-directed vs. 13.0% standard, p=0.9) or CRP level at 24 hours (87.1 mg/dL goal-directed vs. 69.2 mg/dL standard, p=0.97) based on resuscitation strategy. Aim 2: 19 subjects were randomized to LR and 21 to NS. Mean CRP level at 24 hours was lower among patients resuscitated with LR (51.5 mg/dL LR vs. 104 mg/dL NS; p=0.037). There was a trend toward reduced prevalence of SIRS at 24 hours among subjects resuscitated with LR (5.3% LR vs. 19.1% NS, p=0.11). Adverse Events: One subject resuscitated with the goal-directed protocol developed acute respiratory distress syndrome. Conclusion: 1) Goal-directed fluid resuscitation did not lead to reduction in systemic inflammation at 24 hours compared to standard resuscitation. Volume of fluid administered during the initial 24 hours was similar between treatment arms. 2) Patients resuscitated with Lactated Ringer's had reduced systemic inflammation at 24 hours compared to those that received normal saline. (NCT00853515)." @default.
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- W2922505549 date "2010-10-01" @default.
- W2922505549 modified "2023-09-26" @default.
- W2922505549 title "Early Resuscitation with Lactated Ringerʼs Reduces Systemic Inflammation in Acute Pancreatitis: A Multi-Center Randomized-Controlled Trial: 2010 ACG Governors Award Recipient for Excellence in Clinical Research" @default.
- W2922505549 doi "https://doi.org/10.14309/00000434-201010001-00187" @default.
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