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Cited by 92Sepsis Diagnosis and TreatmentAbdominal Surgery and ComplicationsAcute Kidney Injury Research

Unexplained mortality differences between septic shock trials: a systematic analysis of population characteristics and control-group mortality rates

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de Grooth, Harm-Jan, Postema, Jonne, Loer, Stephan A., Parienti, Jean-Jacques, Oudemans-van Straaten, Heleen M., Girbes, Armand R.·2018·Intensive Care Medicine
DOI 10.1007/s00134-018-5134-8PMC PMC5861172
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Abstract

Although the definition of septic shock has been standardized, some variation in mortality rates among clinical trials is expected. Insights into the sources of heterogeneity may influence the design and interpretation of septic shock studies. We set out to identify inclusion criteria and baseline characteristics associated with between-trial differences in control group mortality rates. We conducted a systematic review of RCTs published between 2006 and 2018 that included patients with septic shock. The percentage of variance in control-group mortality attributable to study heterogeneity rather than chance was measured by I 2 . The association between control-group mortality and population characteristics was estimated using linear mixed models and a recursive partitioning algorithm. Sixty-five septic shock RCTs were included. Overall control-group mortality was 38.6%, with significant heterogeneity (I 2 = 93%, P < 0.0001) and a 95% prediction interval of 13.5–71.7%. The mean mortality rate did not differ between trials with different definitions of hypotension, infection or vasopressor or mechanical ventilation inclusion criteria. Population characteristics univariately associated with mortality rates were mean Sequential Organ Failure Assessment score (standardized regression coefficient (β) = 0.57, P = 0.007), mean serum creatinine (β = 0.48, P = 0.007), the proportion of patients on mechanical ventilation (β = 0.61, P < 0.001), and the proportion with vasopressors (β = 0.57, P = 0.002). Combinations of population characteristics selected with a linear model and recursive partitioning explained 41 and 42%, respectively, of the heterogeneity in mortality rates. Among 65 septic shock trials, there was a clinically relevant amount of heterogeneity in control group mortality rates which was explained only partly by differences in inclusion criteria and reported baseline characteristics.

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Authors
de Grooth, H.-J., Postema, J., Loer, S. A., Parienti, J.-J., Oudemans-van Straaten, H. M., & Girbes, A. R.
Affiliations
  • Amsterdam UMC Location Vrije Universiteit Amsterdam (NL)
  • Centre Hospitalier Universitaire de Caen Normandie (FR)
ORCID
Venue
Intensive Care Medicine
Publisher
Springer Science and Business Media LLC
Published
2018-03
Volume
44
Issue
3
Pages
311-322
ISSN
  • 0342-4642 (ISSN-L)
  • 1432-1238
DOI
10.1007/s00134-018-5134-8
PMC
PMC5861172
OpenAlex
W2790798571
Cited by
92
References
102
Citations by year
2026: 6 · 2025: 15 · 2024: 12 · 2023: 12 · 2022: 7 · 2021: 9 · 2020: 12 · 2019: 14 · 2018: 5
FWCI
1.43
Type
journal article
Language
en
Open access
Licence
Locations
  • Intensive Care Medicine (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion, other-oa)
  • HAL (submittedVersion)
  • Pure Amsterdam UMC (submittedVersion, cc-by)
  • Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
Topics
  • Health Sciences › Medicine › Epidemiology › Sepsis Diagnosis and Treatment
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Abdominal Surgery and Complications
  • Health Sciences › Medicine › Nephrology › Acute Kidney Injury Research
Keywords
septic shock, between-trial heterogeneity, trial inclusion criteria, baseline characteristics, SOFA score, serum creatinine, mechanical ventilation, vasopressors, hypotension, trial design
MeSH terms
Adult, Humans, Male, Shock, Septic, Vasoconstrictor Agents, Case-Control Studies, Randomized Controlled Trials as Topic, Sepsis, Organ Dysfunction Scores

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