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Intensive care
Protocol
Corticosteroids in sepsis: an updated systematic review and meta-analysis (protocol)
  1. Bram Rochwerg1,2,
  2. Simon Oczkowski1,
  3. Reed Alexander Siemieniuk2,
  4. Kusum Menon3,
  5. Wojciech Szczeklik1,4,
  6. Shane English5,6,
  7. Thomas Agoritsas2,7,
  8. Emilie Belley-Cote1,2,
  9. Frédérick D’Aragon8,
  10. Waleed Alhazzani1,2,
  11. Erick Duan1,2,
  12. Kira Gossack-Keenan1,
  13. Jon Sevransky9,
  14. Per Vandvik1,10,
  15. Bala Venkatesh11,
  16. Gordon Guyatt12,
  17. Djillali Annane1,13
  1. 1 Department of Medicine, McMaster University, Hamilton, Ontario, Canada
  2. 2 Department of Health Research Methods, Evidence & Impact, McMaster University, Hamilton, Ontario, Canada
  3. 3 Department of Pediatrics, University of Ottawa, Ottawa, Ontario, Canada
  4. 4 Department of Intensive Care and Perioperative Medicine, Jagiellonian University Medical College, Krakow, Poland
  5. 5 Department of Medicine (Critical Care), University of Ottawa, Ottawa, Ontario, Canada
  6. 6 Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
  7. 7 Division of General Internal Medicine & Division of Clinical Epidemiology, University Hospitals of Geneva, Geneva, Switzerland
  8. 8 Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke et Faculté de médecine et des sciences de la santé, Université de Sherbrooke, Sherbrooke, Québec, Canada
  9. 9 Division of Pulmonary, Allergy and Critical Care, Department of Medicine, Emory University, Atlanta, Georgia, USA
  10. 10 Department of Medicine, Innlandet Hospital Trust-Division Gjøvik, Norway
  11. 11 Department of Intensive Care, Wesley Hospital and Princess Alexandra Hospital, University of Queensland, St Lucia, Australia
  12. 12 University of Sydney, Sydney, Australia
  13. 13 Hôpital Raymond Poincaré, Laboratory of Infection and Inflammation, University of Versailles, Garches, France
  1. Correspondence to Dr Bram Rochwerg; rochwerg{at}mcmaster.ca

Abstract

Introduction Sepsis is associated with a dysregulated host response to infection and impaired endogenous corticosteroid metabolism. As such, therapeutic use of exogenous corticosteroids is a promising adjunctive intervention. Despite a large number of trials examining this research question, uncertainty persists regarding the effect of corticosteroids on survival in sepsis. Several large randomised controlled trials have been published recently prompting a re-evaluation of the available literature.

Methods and analysis A rigorous and reproducible search and screening process from a Cochrane review on the same topic was comprehensive to October 2014. We will search MEDLINE, EMBASE, LILACS, the Cochrane trial registry and clinicaltrials.gov for eligible randomised controlled trials investigating the use of corticosteroids in patients with sepsis from September 2014. Outcomes have been chosen by a semi-independent guideline panel, created in the context of a parallel BMJ Rapid Recommendation on the topic. This panel includes clinicians, content experts, methodologists and patient representatives, who will help identify patient-important outcomes that are critical for deciding whether to use or not use corticosteroids in sepsis. Two reviewers will independently screen and identify eligible studies; a third reviewer will resolve any disagreements. We will use RevMan to pool effect estimates from included studies for each outcome using a random-effect model. We will present the results as relative risk with 95% CI for dichotomous outcomes and as mean difference or standardised mean difference for continuous outcomes with 95% CI. We will assess the certainty of evidence at the outcome level using the Grading of Recommendations, Assessment, Development and Evaluation approach. We will conduct a priori subgroup analyses, which have been chosen by the parallel BMJ Rapid Recommendation panel.

Ethics and dissemination The aim of this systematic review is to summarise the updated evidence on the efficacy and safety of corticosteroids in patients with sepsis.

Trial registration number CRD42017058537.

  • Sepsis
  • systematic review
  • corticosteroids
  • shock
  • intensive care
  • meta-analysis

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-016847

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    Footnotes

    • Contributors BR, RS, TA, PV and GG conceived the idea for this systematic review. All authors developed the methodology for the systematic review. The manuscript was drafted by BR and revised by all authors. BR and SO will screen potential studies, perform duplicate independent data abstraction, risk of bias assessment and GRADE assessment with help from RS, TA, WS, WA, ED, FD, EBC and KGK. BR will conduct the data synthesis. BR is the guarantor of the review.

    • Competing interests BR and SO are supported by McMaster University Department of Medicine early career research awards.

    • Provenance and peer review Not commissioned; externally peer reviewed.