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Control groups in recent septic shock trials: a systematic review.

Ville Pettilä1,2, Peter Buhl Hjortrup3, Stephan M Jakob4

  • 1Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. ville.pettilae@insel.ch.

Intensive Care Medicine
|July 25, 2016
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Summary

Reporting of control groups in septic shock trials is often inadequate. Standardized data collection is needed for better interpretation of trial results and patient outcomes.

Keywords:
Control groupRandomizedReportingSeptic shockStandardizationTrial

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Area of Science:

  • Critical care medicine
  • Clinical trial methodology
  • Sepsis research

Background:

  • Interpretation of septic shock trial data is influenced by patient characteristics, interventions, and outcome measures.
  • Evaluating the reporting quality of control groups in septic shock randomized clinical trials (RCTs) is crucial for understanding treatment effects.

Purpose of the Study:

  • To assess the completeness of reporting for control groups in recent adult septic shock RCTs.
  • To identify deficiencies in data collection and reporting that impact the interpretation of trial findings.

Main Methods:

  • Systematic search for RCTs in adult septic shock patients published between 2006 and 2016.
  • Inclusion criteria: at least two parallel groups, ≥50 patients in the control group.
  • Evaluation of data completeness regarding patient characteristics, control group interventions, and mortality outcomes.

Main Results:

  • 24 RCTs were included, with a mean of 287 patients per trial.
  • Inconsistent reporting of baseline data: vasopressor use (58%), elevated lactate (58%), and Sepsis-3 criteria fulfillment (21%).
  • Low data completeness score (mean 19/36); only 8% of trials adequately described control group treatment as usual care.

Conclusions:

  • Recent septic shock trials exhibit inadequate reporting of control group treatments and hemodynamic data.
  • A standardized trial dataset is proposed, including patient characteristics, interventions, hemodynamic values, organ dysfunction, and outcomes.
  • This standardized dataset aims to improve the analysis and interpretation of future septic shock trial results.