Restrictive versus standard IV fluid therapy in adult ICU patients with septic shock—Bayesian analyses of the CLASSIC trial
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Restrictive versus standard IV fluid therapy in adult ICU patients with septic shock—Bayesian analyses of the CLASSIC trial. / Sivapalan, Praleene; Meyhoff, Tine Sylvest; Hjortrup, Peter Buhl; Lange, Theis; Kaas-Hansen, Benjamin Skov; Kjær, Maj Brit N.; Laake, Jon Henrik; Cronhjort, Maria; Jakob, Stephan M.; Cecconi, Maurizio; Nalos, Marek; Ostermann, Marlies; Malbrain, Manu L.N.G.; Møller, Morten Hylander; Perner, Anders; Granholm, Anders.
I: Acta Anaesthesiologica Scandinavica, Bind 68, Nr. 2, 2024, s. 236-246.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Restrictive versus standard IV fluid therapy in adult ICU patients with septic shock—Bayesian analyses of the CLASSIC trial
AU - Sivapalan, Praleene
AU - Meyhoff, Tine Sylvest
AU - Hjortrup, Peter Buhl
AU - Lange, Theis
AU - Kaas-Hansen, Benjamin Skov
AU - Kjær, Maj Brit N.
AU - Laake, Jon Henrik
AU - Cronhjort, Maria
AU - Jakob, Stephan M.
AU - Cecconi, Maurizio
AU - Nalos, Marek
AU - Ostermann, Marlies
AU - Malbrain, Manu L.N.G.
AU - Møller, Morten Hylander
AU - Perner, Anders
AU - Granholm, Anders
N1 - Publisher Copyright: © 2023 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.
PY - 2024
Y1 - 2024
N2 - Background: The CLASSIC trial assessed the effects of restrictive versus standard intravenous (IV) fluid therapy in adult intensive care unit (ICU) patients with septic shock. This pre-planned study provides a probabilistic interpretation and evaluates heterogeneity in treatment effects (HTE). Methods: We analysed mortality, serious adverse events (SAEs), serious adverse reactions (SARs) and days alive without life-support within 90 days using Bayesian models with weakly informative priors. HTE on mortality was assessed according to five baseline variables: disease severity, vasopressor dose, lactate levels, creatinine values and IV fluid volumes given before randomisation. Results: The absolute difference in mortality was 0.2%-points (95% credible interval: −5.0 to 5.4; 47% posterior probability of benefit [risk difference <0.0%-points]) with restrictive IV fluid. The posterior probabilities of benefits with restrictive IV fluid were 72% for SAEs, 52% for SARs and 61% for days alive without life-support. The posterior probabilities of no clinically important differences (absolute risk difference ≤2%-points) between the groups were 56% for mortality, 49% for SAEs, 90% for SARs and 38% for days alive without life-support. There was 97% probability of HTE for previous IV fluid volumes analysed continuously, that is, potentially relatively lower mortality of restrictive IV fluids with higher previous IV fluids. No substantial evidence of HTE was found in the other analyses. Conclusion: We could not rule out clinically important effects of restrictive IV fluid therapy on mortality, SAEs or days alive without life-support, but substantial effects on SARs were unlikely. IV fluids given before randomisation might interact with IV fluid strategy.
AB - Background: The CLASSIC trial assessed the effects of restrictive versus standard intravenous (IV) fluid therapy in adult intensive care unit (ICU) patients with septic shock. This pre-planned study provides a probabilistic interpretation and evaluates heterogeneity in treatment effects (HTE). Methods: We analysed mortality, serious adverse events (SAEs), serious adverse reactions (SARs) and days alive without life-support within 90 days using Bayesian models with weakly informative priors. HTE on mortality was assessed according to five baseline variables: disease severity, vasopressor dose, lactate levels, creatinine values and IV fluid volumes given before randomisation. Results: The absolute difference in mortality was 0.2%-points (95% credible interval: −5.0 to 5.4; 47% posterior probability of benefit [risk difference <0.0%-points]) with restrictive IV fluid. The posterior probabilities of benefits with restrictive IV fluid were 72% for SAEs, 52% for SARs and 61% for days alive without life-support. The posterior probabilities of no clinically important differences (absolute risk difference ≤2%-points) between the groups were 56% for mortality, 49% for SAEs, 90% for SARs and 38% for days alive without life-support. There was 97% probability of HTE for previous IV fluid volumes analysed continuously, that is, potentially relatively lower mortality of restrictive IV fluids with higher previous IV fluids. No substantial evidence of HTE was found in the other analyses. Conclusion: We could not rule out clinically important effects of restrictive IV fluid therapy on mortality, SAEs or days alive without life-support, but substantial effects on SARs were unlikely. IV fluids given before randomisation might interact with IV fluid strategy.
KW - Bayesian analysis
KW - fluid therapy
KW - heterogeneity of treatment effects
KW - intensive care unit
KW - septic shock
U2 - 10.1111/aas.14345
DO - 10.1111/aas.14345
M3 - Journal article
C2 - 37869991
AN - SCOPUS:85174596956
VL - 68
SP - 236
EP - 246
JO - Acta Anaesthesiologica Scandinavica
JF - Acta Anaesthesiologica Scandinavica
SN - 0001-5172
IS - 2
ER -
ID: 372203531