Evidence map›Paper›PMID 33268422›Full record

ArticleBMJ open2020

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.

Djillali Annane, Romain Pirracchio, Laurent Billot, Andre Waschka, Sylvie Chevret, Jeremy Cohen, Simon Finfer, Anthony Gordon, Naomi Hammond, John Myburgh and 3 more

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 34% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 9 institutions in 4 countries.

Djillali AnnaneSchool of Medicine, Versailles Saint-Quentin-en-Yvelines University, Versailles, Île-de-France, France djillali.annane@aphp.fr.ORCID 0000-0001-6805-8944
Romain PirracchioZuckerberg San Francisco General Hospital and Trauma Center, San Francisco, California, USA.
Laurent BillotStatistics Division, The George Institute for Global Health, Newtown, New South Wales, Australia.ORCID 0000-0002-4975-9793
Andre WaschkaUniversity of California Berkeley, Berkeley, California, USA.
Sylvie ChevretUniversity of Paris, Paris, Île-de-France, France.
Jeremy CohenUniversity of Queensland, Brisbane, Queensland, Australia.
Simon FinferThe George Institute for Global Health, Newtown, New South Wales, Australia.
Anthony GordonSection of Anaesthetics, Pain Medicine and Intensive Care, Imperial College London, London, UK.
Naomi HammondGeorge Institute for Global Health, Camperdown, New South Wales, Australia.
John MyburghSt George Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
Balasubramanian VenkateshRoyal Brisbane and Women's Hospital, Herston, Queensland, Australia.
Anthony DelaneyThe George Institute for Global Health, Newtown, New South Wales, Australia.
ULYSSES IPDMA Collaborators
The University of Sydney · AUImperial College London · GBRoyal Brisbane and Women's Hospital · AUSan Francisco General Hospital · USThe University of Queensland · AUUniversité de Versailles Saint-Quentin-en-Yvelines · FRUniversité Paris Cité · FRUniversity of California, Berkeley · USUNSW Sydney · AU

Funding

Department of Health NIHR/CS/009/007Department of Health PB-PG-0610-22350Department of Health RP-2015-06-018
6 · The paper itself

Abstract

introductionThe 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.

Indexed as

FludrocortisoneShock, SepticAdultCaribbean RegionHumansHydrocortisoneMeta-Analysis as TopicFludrocortisoneHydrocortisoneadult intensive & critical careclinical pharmacologyclinical trials

Identifiers

PMID33268422
PMCPMC7713227
OpenAlexW3107538338

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.