Evidence map›Paper›PMID 27741949›Full record

Trial reportCritical care (London, England)2016

Hydrocortisone treatment in early sepsis-associated acute respiratory distress syndrome: results of a randomized controlled trial.

Surat Tongyoo, Chairat Permpikul, Wasineenart Mongkolpun, Veerapong Vattanavanit, Suthipol Udompanturak, Mehmet Kocak, G Umberto Meduri

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Critical care (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 126 papers, 40 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
126citing papers in PubMed, 40 pooled it
10.5field-weighted citation impact, top 1% 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.

NCT01284452 nacompletednot on this map

Efficacy of Moderate Dose Hydrocortisone in Treatment of Severe Sepsis and Septic Shock Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome: A Randomized Controlled Trial

TypeinterventionalSponsorMahidol UniversityRan2010 to 2015Enrolled197ConditionsSeptic Shock, Severe Sepsis, Acute Lung Injury, Acute Respiratory Distress SyndromeArmsPlacebo, Hydrocortisone
NCT07511582 phase2recruitingnot on this mapstarted 2026, after this paper: background citation

Efficacy, Safety, and Tolerability of Methylprednisolone in Critically Ill Patients With the Hyperinflammatory Phenotype: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Trial

TypeinterventionalSponsorBin DuRan2026 to 2028Enrolled150ConditionsSepsis, Acute Respiratory Distress SyndromeArmsMethylprednisolone (MP), Placebo
3 · Its place in the literature

Who cites it

126 citing papers in PubMed, 40 syntheses or guidelines pooled it, 237 citations in OpenAlex.

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  10. Corticosteroids for treating sepsis in children and adults.The Cochrane database of systematic reviews · 2025
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66 more citing papers are in PubMed but not listed here.

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

7 authors at 3 institutions in 2 countries.

Surat TongyooFaculty of Medicine, Siriraj Hospital, Mahidol University, No. 2, Prannok Road, Bangkoknoi, Bangkok, 10700, Thailand. surat_ty@yahoo.co.uk.ORCID 0000-0003-3772-2990
Chairat PermpikulFaculty of Medicine, Siriraj Hospital, Mahidol University, No. 2, Prannok Road, Bangkoknoi, Bangkok, 10700, Thailand.
Wasineenart MongkolpunFaculty of Medicine, Siriraj Hospital, Mahidol University, No. 2, Prannok Road, Bangkoknoi, Bangkok, 10700, Thailand.
Veerapong VattanavanitFaculty of Medicine, Siriraj Hospital, Mahidol University, No. 2, Prannok Road, Bangkoknoi, Bangkok, 10700, Thailand.
Suthipol UdompanturakFaculty of Medicine, Siriraj Hospital, Mahidol University, No. 2, Prannok Road, Bangkoknoi, Bangkok, 10700, Thailand.
Mehmet KocakDepartment of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.
G Umberto MeduriDivision of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Memphis Veterans Affairs Medical Center, Memphis, TN, USA.
Siriraj Hospital · THPrince of Songkla University · THUniversity of Tennessee Health Science Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAuthors of recent meta-analyses have reported that prolonged glucocorticoid treatment is associated with significant improvements in patients with severe pneumonia or acute respiratory distress syndrome (ARDS) of multifactorial etiology. A prospective randomized trial limited to patients with sepsis-associated ARDS is lacking. The objective of our study was to evaluate the efficacy of hydrocortisone treatment in sepsis-associated ARDS.

methodsIn this double-blind, single-center (Siriraj Hospital, Bangkok), randomized, placebo-controlled trial, we recruited adult patients with severe sepsis within 12 h of their meeting ARDS criteria. Patients were randomly assigned (1:1 ratio) to receive either hydrocortisone 50 mg every 6 h or placebo. The primary endpoint was 28-day all-cause mortality; secondary endpoints included survival without organ support on day 28.

resultsOver the course of 4 years, 197 patients were randomized to either hydrocortisone (n = 98) or placebo (n = 99) and were included in this intention-to-treat analysis. The treatment group had significant improvement in the ratio of partial pressure of oxygen in arterial blood to fraction of inspired oxygen and lung injury score (p = 0.01), and similar timing to removal of vital organ support (HR 0.74, 95 % CI 0.51-1.07; p = 0.107). After adjustment for significant covariates, day 28 survival was similar for the whole group (HR 0.80, 95 % CI 0.46-1.41; p = 0.44) and for the larger subgroup (n = 126) with Acute Physiology and Chronic Health Evaluation II score <25 (HR 0.57, 95 % CI 0.24-1.36; p = 0.20). With the exception of hyperglycemia (80.6 % vs. 67.7 %; p = 0.04), the rate of adverse events was similar. Hyperglycemia had no impact on outcome.

conclusionsIn sepsis-associated ARDS, hydrocortisone treatment was associated with a significant improvement in pulmonary physiology, but without a significant survival benefit.

trial registrationClinicalTrials.gov identifier NCT01284452 . Registered on 18 January 2011.

Indexed as

AgedAged, 80 and overBlood Gas AnalysisDouble-Blind MethodFemaleHospital MortalityHumansHydrocortisoneInfusions, IntravenousIntensive Care UnitsMaleMiddle AgedProspective StudiesRespiratory Distress SyndromeSepsisThailandHydrocortisoneARDSGlucocorticoid treatmentHydrocortisoneRandomized trialSeptic shockSevere sepsis

Identifiers

PMID27741949
PMCPMC5065699
OpenAlexW2530180760

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.