Conservative vs. liberal fluid therapy in septic shock – Protocol for secondary Bayesian analyses of the CLASSIC trial

Sivapalan, Praleene; Meyhoff, Tine Sylvest; Hjortrup, Peter Buhl; Lange, Theis; Møller, Morten Hylander; Perner, Anders; Granholm, Anders

doi:10.1111/aas.14058

Cited by 5 publications

(24 citation statements)

References 28 publications

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“…All analyses were adjusted for the stratification variables (trial site and absence or presence of haematologic/metastatic cancer). 4,5…”

Section: Statistical Analysesmentioning

confidence: 99%

“…Herein, we present a pre-planned secondary analysis of the CLAS-SIC trial using Bayesian inference. 5 We aim to provide probabilistic interpretations of the CLASSIC results to aid researchers and clinicians with decision-making. The Bayesian analysis provides direct probabilities and allows a more straightforward way to quantify uncertainties using credible intervals (CrI) representing a range within which the true parameter value falls with a certain probability.…”

Section: Introductionmentioning

confidence: 99%

“…4 Therefore, we hypothesised that restricted IV fluid would reduce 90-day mortality and the effects might be larger in patients with greater severity of illness and more pronounced circulatory or renal impairment. 5…”

Section: Introductionmentioning

confidence: 99%

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Restrictive versus standard IV fluid therapy in adult ICU patients with septic shock—Bayesian analyses of the CLASSIC trial

Sivapalan,

Meyhoff,

Hjortrup

et al. 2023

Acta Anaesthesiol Scand

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BackgroundThe 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).MethodsWe 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.ResultsThe 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.ConclusionWe 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.

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“…All analyses were adjusted for the stratification variables (trial site and absence or presence of haematologic/metastatic cancer). 4,5…”

Section: Statistical Analysesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Restrictive versus standard IV fluid therapy in adult ICU patients with septic shock—Bayesian analyses of the CLASSIC trial

Sivapalan,

Meyhoff,

Hjortrup

et al. 2023

Acta Anaesthesiol Scand

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“…However, the priors used in this study are weakly informative which means they will have little influence on the results, and they will easily be overwhelmed by the data. The clinically important benefit or harm may be defined differently by others; however, these thresholds have been used in previous work performed by the group and all effect sizes will be available in plots of posterior distribution for the parameters of primary interest 26,40 …”

Section: Discussionmentioning

confidence: 99%

“…The clinically important benefit or harm may be defined differently by others; however, these thresholds have been used in previous work performed by the group and all effect sizes will be available in plots of posterior distribution for the parameters of primary interest. 26,40…”

Section: Strength and Limitationsmentioning

confidence: 99%

Agents intervening against delirium in the intensive care unit trial—Protocol for a secondary Bayesian analysis

Andersen-Ranberg

Poulsen

Perner

et al. 2022

Acta Anaesthesiol Scand

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Background: Delirium is highly prevalent in the intensive care unit (ICU) and is associated with high morbidity and mortality. The antipsychotic haloperidol is the most frequently used agent to treat delirium although this is not supported by solid evidence.The agents intervening against delirium in the intensive care unit (AID-ICU) trial investigates the effects of haloperidol versus placebo for the treatment of delirium in adult ICU patients.Methods: This protocol describes the secondary, pre-planned Bayesian analyses of the primary and secondary outcomes up to day 90 of the AID-ICU trial. We will use

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The effect of high protein dosing in critically ill patients: an exploratory, secondary Bayesian analyses of the EFFORT Protein trial

Haines,

Granholm,

Puthucheary

et al. 2024

British Journal of Anaesthesia

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Conservative vs. liberal fluid therapy in septic shock – Protocol for secondary Bayesian analyses of the CLASSIC trial

Cited by 5 publications

References 28 publications

Restrictive versus standard IV fluid therapy in adult ICU patients with septic shock—Bayesian analyses of the CLASSIC trial

Restrictive versus standard IV fluid therapy in adult ICU patients with septic shock—Bayesian analyses of the CLASSIC trial

Agents intervening against delirium in the intensive care unit trial—Protocol for a secondary Bayesian analysis

The effect of high protein dosing in critically ill patients: an exploratory, secondary Bayesian analyses of the EFFORT Protein trial

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