Matches in SemOpenAlex for { <https://semopenalex.org/work/W2132022166> ?p ?o ?g. }
- W2132022166 abstract "Swine origin influenza A/H1N1 infection (H1N1) emerged in early 2009 and rapidly spread to humans. For most infected individuals, symptoms were mild and self-limited; however, a small number developed a more severe clinical syndrome characterized by profound respiratory failure with hospital mortality ranging from 10 to 30%. While supportive care and neuraminidase inhibitors are the main treatment for influenza, data from observational and interventional studies suggest that the course of influenza can be favorably influenced by agents not classically considered as influenza treatments. Multiple observational studies have suggested that HMGCoA reductase inhibitors (statins) can exert a class effect in attenuating inflammation. The Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial sought to investigate the feasibility of conducting a trial during a global pandemic in critically ill patients with H1N1 with the goal of informing the design of a larger trial powered to determine impact of statins on important outcomes. A multi-national, pilot randomized controlled trial (RCT) of once daily enteral rosuvastatin versus matched placebo administered for 14 days for the treatment of critically ill patients with suspected, probable or confirmed H1N1 infection. We propose to randomize 80 critically ill adults with a moderate to high index of suspicion for H1N1 infection who require mechanical ventilation and have received antiviral therapy for ≤ 72 hours. Site investigators, research coordinators and clinical pharmacists will be blinded to treatment assignment. Only research pharmacy staff will be aware of treatment assignment. We propose several approaches to informed consent including a priori consent from the substitute decision maker (SDM), waived and deferred consent. The primary outcome of the CHAT trial is the proportion of eligible patients enrolled in the study. Secondary outcomes will evaluate adherence to medication administration regimens, the proportion of primary and secondary endpoints collected, the number of patients receiving open-label statins, consent withdrawals and the effect of approved consent models on recruitment rates. Several aspects of study design including the need to include central randomization, preserve allocation concealment, ensure study blinding compare to a matched placebo and the use novel consent models pose challenges to investigators conducting pandemic research. Moreover, study implementation requires that trial design be pragmatic and initiated in a short time period amidst uncertainty regarding the scope and duration of the pandemic. ISRCTN45190901" @default.
- W2132022166 created "2016-06-24" @default.
- W2132022166 creator A5000256626 @default.
- W2132022166 creator A5012164007 @default.
- W2132022166 creator A5027523315 @default.
- W2132022166 creator A5027894557 @default.
- W2132022166 creator A5035524531 @default.
- W2132022166 creator A5035742443 @default.
- W2132022166 creator A5037799880 @default.
- W2132022166 creator A5046427478 @default.
- W2132022166 creator A5053198362 @default.
- W2132022166 creator A5053987777 @default.
- W2132022166 creator A5067168750 @default.
- W2132022166 creator A5070604004 @default.
- W2132022166 creator A5084752934 @default.
- W2132022166 date "2011-03-09" @default.
- W2132022166 modified "2023-10-14" @default.
- W2132022166 title "A Canadian Critical Care Trials Group project in collaboration with the international forum for acute care trialists - Collaborative H1N1 Adjuvant Treatment pilot trial (CHAT): study protocol and design of a randomized controlled trial" @default.
- W2132022166 cites W1502204933 @default.
- W2132022166 cites W1935234591 @default.
- W2132022166 cites W1983592112 @default.
- W2132022166 cites W1987783718 @default.
- W2132022166 cites W1990018624 @default.
- W2132022166 cites W1993439431 @default.
- W2132022166 cites W2004106288 @default.
- W2132022166 cites W2005215395 @default.
- W2132022166 cites W2025557550 @default.
- W2132022166 cites W2033511358 @default.
- W2132022166 cites W2035933971 @default.
- W2132022166 cites W2040363074 @default.
- W2132022166 cites W2067474072 @default.
- W2132022166 cites W2078073214 @default.
- W2132022166 cites W2088449260 @default.
- W2132022166 cites W2104134630 @default.
- W2132022166 cites W2107097240 @default.
- W2132022166 cites W2111359724 @default.
- W2132022166 cites W2119611042 @default.
- W2132022166 cites W2120682265 @default.
- W2132022166 cites W2125870353 @default.
- W2132022166 cites W2126287031 @default.
- W2132022166 cites W2133959948 @default.
- W2132022166 cites W2139525991 @default.
- W2132022166 cites W2139841187 @default.
- W2132022166 cites W2140252537 @default.
- W2132022166 cites W2148183046 @default.
- W2132022166 cites W2148958087 @default.
- W2132022166 cites W2149533101 @default.
- W2132022166 cites W2149980324 @default.
- W2132022166 cites W2152165117 @default.
- W2132022166 cites W2157629995 @default.
- W2132022166 cites W2162080474 @default.
- W2132022166 cites W2171580171 @default.
- W2132022166 doi "https://doi.org/10.1186/1745-6215-12-70" @default.
- W2132022166 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/3068961" @default.
- W2132022166 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/21388549" @default.
- W2132022166 hasPublicationYear "2011" @default.
- W2132022166 type Work @default.
- W2132022166 sameAs 2132022166 @default.
- W2132022166 citedByCount "7" @default.
- W2132022166 countsByYear W21320221662013 @default.
- W2132022166 countsByYear W21320221662015 @default.
- W2132022166 countsByYear W21320221662017 @default.
- W2132022166 countsByYear W21320221662018 @default.
- W2132022166 crossrefType "journal-article" @default.
- W2132022166 hasAuthorship W2132022166A5000256626 @default.
- W2132022166 hasAuthorship W2132022166A5012164007 @default.
- W2132022166 hasAuthorship W2132022166A5027523315 @default.
- W2132022166 hasAuthorship W2132022166A5027894557 @default.
- W2132022166 hasAuthorship W2132022166A5035524531 @default.
- W2132022166 hasAuthorship W2132022166A5035742443 @default.
- W2132022166 hasAuthorship W2132022166A5037799880 @default.
- W2132022166 hasAuthorship W2132022166A5046427478 @default.
- W2132022166 hasAuthorship W2132022166A5053198362 @default.
- W2132022166 hasAuthorship W2132022166A5053987777 @default.
- W2132022166 hasAuthorship W2132022166A5067168750 @default.
- W2132022166 hasAuthorship W2132022166A5070604004 @default.
- W2132022166 hasAuthorship W2132022166A5084752934 @default.
- W2132022166 hasBestOaLocation W21320221661 @default.
- W2132022166 hasConcept C104863432 @default.
- W2132022166 hasConcept C126322002 @default.
- W2132022166 hasConcept C142724271 @default.
- W2132022166 hasConcept C168563851 @default.
- W2132022166 hasConcept C177713679 @default.
- W2132022166 hasConcept C204787440 @default.
- W2132022166 hasConcept C23131810 @default.
- W2132022166 hasConcept C2776376669 @default.
- W2132022166 hasConcept C2777538117 @default.
- W2132022166 hasConcept C2779134260 @default.
- W2132022166 hasConcept C3008058167 @default.
- W2132022166 hasConcept C512399662 @default.
- W2132022166 hasConcept C524204448 @default.
- W2132022166 hasConcept C535046627 @default.
- W2132022166 hasConcept C68122502 @default.
- W2132022166 hasConcept C71924100 @default.
- W2132022166 hasConceptScore W2132022166C104863432 @default.
- W2132022166 hasConceptScore W2132022166C126322002 @default.
- W2132022166 hasConceptScore W2132022166C142724271 @default.
- W2132022166 hasConceptScore W2132022166C168563851 @default.
- W2132022166 hasConceptScore W2132022166C177713679 @default.
- W2132022166 hasConceptScore W2132022166C204787440 @default.