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Control groups in recent septic shock trials: a systematic review

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Abstract

Purpose

The interpretation of septic shock trial data is profoundly affected by patients, control intervention, co-interventions and selected outcome measures. We evaluated the reporting of control groups in recent septic shock trials.

Methods

We searched for original articles presenting randomized clinical trials (RCTs) in adult septic shock patients from 2006 to 2016. We included RCTs focusing on septic shock patients with at least two parallel groups and at least 50 patients in the control group. We selected and evaluated data items regarding patients, control group characteristics, and mortality outcomes, and calculated a data completeness score to provide an overall view of quality of reporting.

Results

A total of 24 RCTs were included (mean n = 287 patients and 71 % of eligible patients were randomized). Of the 24 studies, 14 (58 %) presented baseline data on vasopressors and 58 % the proportion of patients with elevated lactate values. Five studies (21 %) provided data to estimate the proportion of septic shock patients fulfilling the Sepsis-3 definition. The mean data completeness score was 19 out of 36 (range 8–32). Of 18 predefined control group characteristics, a mean of 8 (range 2–17) were reported. Only 2 (8 %) trials provided adequate data to confirm that their control group treatment represented usual care.

Conclusions

Recent trials in septic shock provide inadequate data on the control group treatment and hemodynamic values. We propose a standardized trial dataset to be created and validated, comprising characteristics of patient population, interventions administered, hemodynamic values achieved, surrogate organ dysfunction, and mortality outcomes, to allow better analysis and interpretation of future trial results.

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Acknowledgments

We would like to thank Information Specialist Tiina M. Heino, MSc from Terkko Library (Helsinki, Finland) for performing the literature searches, and medical editor Jeannie Wurz (Bern, Switzerland) for careful editing of the manuscript.

Author information

Authors and Affiliations

  1. Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

    Ville Pettilä, Stephan M. Jakob & Jukka Takala

  2. Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland

    Ville Pettilä & Erika Wilkman

  3. Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

    Peter Buhl Hjortrup & Anders Perner

  4. CRIC, Center of Research for Intensive Care, Copenhagen, Denmark

    Anders Perner

Authors
  1. Ville Pettilä
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  2. Peter Buhl Hjortrup
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  3. Stephan M. Jakob
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  4. Erika Wilkman
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  5. Anders Perner
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  6. Jukka Takala
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Corresponding author

Correspondence to Ville Pettilä.

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Conflicts of interest

The authors declare that they have no conflicts of interest regarding this contribution. AP was the principal investigator of 6S and TRISS trials, PH co-authored the TRISS trial, and VP co-authored TRISS and ARISE trials and contributed as an investigator to EXTENDED APC, PROWESS-SHOCK, and 6S trials.

Additional information

Take-home message: Recent trials in septic shock provide inadequate data on the treatment given the control group and the hemodynamic values achieved. We propose a standardized trial dataset comprising characteristics of patient population, co-interventions administered, hemodynamic values achieved, surrogate organ dysfunction, and mortality outcomes.

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Pettilä, V., Hjortrup, P.B., Jakob, S.M. et al. Control groups in recent septic shock trials: a systematic review. Intensive Care Med 42, 1912–1921 (2016). https://doi.org/10.1007/s00134-016-4444-y

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  • DOI: https://doi.org/10.1007/s00134-016-4444-y

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