Effects of low-dose hydrocortisone and hydrocortisone plus fludrocortisone in adults with septic shock: a protocol for a systematic review and meta-analysis of individual participant data
Introduction The benefits and risks of low-dose hydrocortisone in patients with septic shock have been investigated in numerous randomised controlled trials and trial-level meta-analyses. Yet, the routine use of this treatment remains controversial. To overcome the limitations of previous meta-analy...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2020-12-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/12/e040931.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1846159982737752064 |
|---|---|
| author | Yaseen Arabi Sylvie Chevret Laurent Billot Anthony Gordon Didier Keh Romain Pirracchio Balasubramanian Venkatesh Djillali Annane Andre Waschka Jeremy Cohen Simon Finfer Naomi Hammond John Myburgh Anthony Delaney Pierre Edouard Bollaert Josef Briegel Ling Liu G Umberto Liliana Mirea L Charles Nejla Tilouche Surat Tongyoo Ruiqiang Zheng |
| author_facet | Yaseen Arabi Sylvie Chevret Laurent Billot Anthony Gordon Didier Keh Romain Pirracchio Balasubramanian Venkatesh Djillali Annane Andre Waschka Jeremy Cohen Simon Finfer Naomi Hammond John Myburgh Anthony Delaney Pierre Edouard Bollaert Josef Briegel Ling Liu G Umberto Liliana Mirea L Charles Nejla Tilouche Surat Tongyoo Ruiqiang Zheng |
| author_sort | Yaseen Arabi |
| collection | DOAJ |
| description | Introduction The benefits and risks of low-dose hydrocortisone in patients with septic shock have been investigated in numerous randomised controlled trials and trial-level meta-analyses. Yet, the routine use of this treatment remains controversial. To overcome the limitations of previous meta-analyses inherent to the use of aggregate data, we will perform an individual patient data meta-analysis (IPDMA) on the effect of hydrocortisone with or without fludrocortisone compared with placebo or usual care on 90-day mortality and other outcomes in patients with septic shock.Methods and analysis To assess the benefits and risks of hydrocortisone, with or without fludrocortisone for adults with septic shock, we will search major electronic databases from inception to September 2020 (Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and Latin American Caribbean Health Sciences Literature), complimented by a search for unpublished trials. The primary analysis will compare hydrocortisone with or without fludrocortisone to placebo or no treatment in adult patients with septic shock. Secondary analyses will compare hydrocortisone to placebo (or usual care), hydrocortisone plus fludrocortisone to placebo (or usual care), and hydrocortisone versus hydrocortisone plus fludrocortisone. The primary outcome will be all cause mortality at 90 days. We will conduct both one-stage IPDMA using mixed-effect models and machine learning with targeted maximum likelihood analyses. We will assess the risk of bias related to unshared data and related to the quality of individual trial.Ethics and dissemination This IPDMA will use existing data from completed randomised clinical trials and will comply with the ethical and regulatory requirements regarding data sharing for each of the component trials. The findings of this study will be submitted for publication in a peer-review journal with straightforward policy for open access.PROSPERO registration number CRD42017062198. |
| format | Article |
| id | doaj-art-47c58406ed8142dfb1db7256d612fe00 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-47c58406ed8142dfb1db7256d612fe002024-11-22T14:15:08ZengBMJ Publishing GroupBMJ Open2044-60552020-12-01101210.1136/bmjopen-2020-040931Effects of low-dose hydrocortisone and hydrocortisone plus fludrocortisone in adults with septic shock: a protocol for a systematic review and meta-analysis of individual participant dataYaseen Arabi0Sylvie Chevret1Laurent Billot2Anthony Gordon3Didier Keh4Romain Pirracchio5Balasubramanian Venkatesh6Djillali Annane7Andre Waschka8Jeremy Cohen9Simon Finfer10Naomi Hammond11John Myburgh12Anthony Delaney13Pierre Edouard BollaertJosef BriegelLing Liu14G UmbertoLiliana MireaL CharlesNejla TiloucheSurat TongyooRuiqiang Zheng12 Intensive Care Department, King Abdullah International Medical Research Center, Riyadh, Saudi ArabiaSaint Louis University Hospital, Department of Biostatistics, Paris, France10 The George Institute for Global Health, University of New South Wales, Sydney, AustraliaSection of Anaesthetics, Pain Medicine and Intensive Care, Imperial College London, London, UKattending physicianDepartment of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco, California, USARoyal Brisbane and Women’s Hospital, Herston, Queensland, AustraliaIHU PROMETHEUS, General ICU, Raymond Poincaré Hospital, University Paris Saclay campus Versailles, APHP, Garches, FranceUniversity of California Berkeley, Berkeley, California, USAUniversity of Queensland, Brisbane, Queensland, Australia4 Critical Care Program, The George Institute for Global Health, Sydney, New South Wales, AustraliaGeorge Institute for Global Health, Camperdown, New South Wales, Australia7 The George Institute for Global Health, Newtown, New South Wales, AustraliaIntensive Care, Royal North Shore Hospital, St Leonards, New South Wales, AustraliaDepartment of Ophthalmology, Chongqing Emergency Medical Center; Chongqing University Central Hospital, Chongqing University, Chongqing, ChinaIntroduction The benefits and risks of low-dose hydrocortisone in patients with septic shock have been investigated in numerous randomised controlled trials and trial-level meta-analyses. Yet, the routine use of this treatment remains controversial. To overcome the limitations of previous meta-analyses inherent to the use of aggregate data, we will perform an individual patient data meta-analysis (IPDMA) on the effect of hydrocortisone with or without fludrocortisone compared with placebo or usual care on 90-day mortality and other outcomes in patients with septic shock.Methods and analysis To assess the benefits and risks of hydrocortisone, with or without fludrocortisone for adults with septic shock, we will search major electronic databases from inception to September 2020 (Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and Latin American Caribbean Health Sciences Literature), complimented by a search for unpublished trials. The primary analysis will compare hydrocortisone with or without fludrocortisone to placebo or no treatment in adult patients with septic shock. Secondary analyses will compare hydrocortisone to placebo (or usual care), hydrocortisone plus fludrocortisone to placebo (or usual care), and hydrocortisone versus hydrocortisone plus fludrocortisone. The primary outcome will be all cause mortality at 90 days. We will conduct both one-stage IPDMA using mixed-effect models and machine learning with targeted maximum likelihood analyses. We will assess the risk of bias related to unshared data and related to the quality of individual trial.Ethics and dissemination This IPDMA will use existing data from completed randomised clinical trials and will comply with the ethical and regulatory requirements regarding data sharing for each of the component trials. The findings of this study will be submitted for publication in a peer-review journal with straightforward policy for open access.PROSPERO registration number CRD42017062198.https://bmjopen.bmj.com/content/10/12/e040931.full |
| spellingShingle | Yaseen Arabi Sylvie Chevret Laurent Billot Anthony Gordon Didier Keh Romain Pirracchio Balasubramanian Venkatesh Djillali Annane Andre Waschka Jeremy Cohen Simon Finfer Naomi Hammond John Myburgh Anthony Delaney Pierre Edouard Bollaert Josef Briegel Ling Liu G Umberto Liliana Mirea L Charles Nejla Tilouche Surat Tongyoo Ruiqiang Zheng Effects of low-dose hydrocortisone and hydrocortisone plus fludrocortisone in adults with septic shock: a protocol for a systematic review and meta-analysis of individual participant data BMJ Open |
| title | Effects of low-dose hydrocortisone and hydrocortisone plus fludrocortisone in adults with septic shock: a protocol for a systematic review and meta-analysis of individual participant data |
| title_full | Effects of low-dose hydrocortisone and hydrocortisone plus fludrocortisone in adults with septic shock: a protocol for a systematic review and meta-analysis of individual participant data |
| title_fullStr | Effects of low-dose hydrocortisone and hydrocortisone plus fludrocortisone in adults with septic shock: a protocol for a systematic review and meta-analysis of individual participant data |
| title_full_unstemmed | Effects of low-dose hydrocortisone and hydrocortisone plus fludrocortisone in adults with septic shock: a protocol for a systematic review and meta-analysis of individual participant data |
| title_short | Effects of low-dose hydrocortisone and hydrocortisone plus fludrocortisone in adults with septic shock: a protocol for a systematic review and meta-analysis of individual participant data |
| title_sort | effects of low dose hydrocortisone and hydrocortisone plus fludrocortisone in adults with septic shock a protocol for a systematic review and meta analysis of individual participant data |
| url | https://bmjopen.bmj.com/content/10/12/e040931.full |
| work_keys_str_mv | AT yaseenarabi effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata AT sylviechevret effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata AT laurentbillot effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata AT anthonygordon effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata AT didierkeh effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata AT romainpirracchio effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata AT balasubramanianvenkatesh effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata AT djillaliannane effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata AT andrewaschka effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata AT jeremycohen effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata AT simonfinfer effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata AT naomihammond effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata AT johnmyburgh effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata AT anthonydelaney effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata AT pierreedouardbollaert effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata AT josefbriegel effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata AT lingliu effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata AT gumberto effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata AT lilianamirea effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata AT lcharles effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata AT nejlatilouche effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata AT surattongyoo effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata AT ruiqiangzheng effectsoflowdosehydrocortisoneandhydrocortisoneplusfludrocortisoneinadultswithsepticshockaprotocolforasystematicreviewandmetaanalysisofindividualparticipantdata |