Evidence map›Paper›PMID 25776532›Full record

Trial reportThe New England journal of medicine2015

Trial of early, goal-directed resuscitation for septic shock.

Paul R Mouncey, Tiffany M Osborn, G Sarah Power, David A Harrison, M Zia Sadique, Richard D Grieve, Rahi Jahan, Sheila E Harvey, Derek Bell, Julian F Bion and 5 more

9 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyPragmatic Clinical TrialRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 9 registered trials, which are not on this map. Cited by 632 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
632citing papers in PubMed, 9 pooled it
161.4field-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.

NCT02565251 naunknown statusnot on this map

Volemic Resuscitation in Sepsis and Septic Shock

TypeinterventionalSponsorIuliu Hatieganu University of Medicine and PharmacyRan2015 to 2017Enrolled100ConditionsHemodynamic Instability, Sepsis, Septic ShockArmsFlotrac/Ev1000, Standard ICU monitorisation, VolumeView/Ev1000
NCT02950753 early_phase1completednot on this mapstarted 2017, after this paper: background citation

Does Intravenous Lactated Ringer Solution Raise Measured Serum Lactate?

TypeinterventionalSponsorUniversity Medical Center of Southern NevadaRan2017 to 2017Enrolled30ConditionsHyperlactatemiaArmsLactated Ringer Solution, Normal Saline
NCT03137446 nacompletednot on this mapstarted 2017, after this paper: background citation

Assessing Targeted Fluid Resuscitation Strategies Among Patients With Severe Sepsis and Septic Shock

TypeinterventionalSponsorRhode Island HospitalRan2017 to 2018Enrolled113ConditionsSeptic Shock, Severe SepsisArmsIntravenous Fluid Cap
NCT03422159 phase2completednot on this mapstarted 2018, after this paper: background citation

Outcomes of Metabolic Resuscitation Using Ascorbic Acid, Thiamine, and Glucocorticoids in the Early Treatment of Sepsis.

TypeinterventionalSponsorCommunity Medical Center, Toms River, NJRan2018 to 2019Enrolled140ConditionsSepsis, Severe, Septic ShockArmsAscorbic Acid, Thiamine, Hydrocortisone, Sodium Chloride 0.9%
NCT04134624 naterminatednot on this mapstarted 2019, after this paper: background citation

EMS Prehospital Blood Culture Collection and Antibiotic Administration: A Two-Phase Pilot Project to Reduce Mortality in Patients With Severe Sepsis and Septic Shock

TypeinterventionalSponsorHealthPartners InstituteRan2019 to 2021Enrolled215ConditionsSepsis, Sepsis, Severe, Septic ShockArmsSepsis care bundle
NCT05441878 phase4unknown statusnot on this mapstarted 2020, after this paper: background citation

To Compare 20% Albumin vs. Balanced Salt Solution as Resuscitation Fluid and Identify Fluid Responsiveness Criteria in Critically Ill Patients With Cirrhosis With Sepsis Induced Hypotension; a Prospective Randomized Controlled Trial.

TypeinterventionalSponsorPost Graduate Institute of Medical Education and Research, ChandigarhRan2020 to 2023Enrolled150ConditionsCirrhosis, Liver, Acute-On-Chronic Liver Failure, Shock, Septic, Shock HypovolemicArms20% albumin, Balanced salt solution
NCT06757985 nanot yet recruitingnot on this mapstarted 2024, after this paper: background citation

Doppler Echocardiography Versus Clinical Targets Guided Therapy on the Outcome of Postpartum Septic Shock, a Randomized Controlled Trial

TypeinterventionalSponsorAssiut UniversityRan2024 to 2026Enrolled60ConditionsDoppler Echocardiography, Postpartum Septic ShockArmsa clinically guided resuscitation protocol,, a transthoracic bedside focused echocardiographic assessment
NCT07172451 phase4recruitingnot on this mapstarted 2026, after this paper: background citation

Efficacy and Safety of Balanced Gelatin Solution for Fluid Infusion in Sepsis Patients Undergoing Emergency Abdominal Surgery: A Multicenter, Adaptive Designed, Randomized Controlled Trial

TypeinterventionalSponsorShanghai Zhongshan HospitalRan2026 to 2028Enrolled318ConditionsSepsis, Intra-Abdominal InfectionsArmsBalanced Gelatin Solution, Acetate Ringer's Solution
NCT07179276 narecruitingnot on this mapstarted 2026, after this paper: background citation

Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock: A Multicenter Prospective Randomized Trial (CARBON)

TypeinterventionalSponsorUniversity Hospital, Clermont-FerrandRan2026 to 2027Enrolled750ConditionsSepsis - to Reduce Mortality in the Intensive Care Unit, Septic ShockArmsCO2gap-guided resuscitation strategy
3 · Its place in the literature

Who cites it

632 citing papers in PubMed, 9 syntheses or guidelines pooled it, 1,582 citations in OpenAlex.

  1. Pooled it
  2. [S3 guideline on sepsis-prevention, diagnosis, therapy, and follow-up care-update 2025].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2025
    Guideline
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  20. Review

572 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 8 institutions in 2 countries.

Paul R MounceyFrom the Clinical Trials Unit, Intensive Care National Audit and Research Centre (P.R.M., G.S.P., D.A.H., R.J., S.E.H., K.M.R.), Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine (M.Z.S., R.D.G.), and Faculty of Medicine, Imperial College London (D.B.), Department of Acute Medicine, Chelsea and Westminster Hospital NHS Foundation Trust (D.B.), and Bloomsbury Institute of Intensive Care Medicine, University College London (M.S.), London, the Department of Intensive Care Medicine, University of Birmingham, Birmingham (J.F.B.), Department of Cardiovascular Sciences, University of Leicester, Leicester (T.J.C.), and Nuffield Division of Anaesthetics, University of Oxford, Oxford (J.D.Y.) - all in the United Kingdom; and the Departments of Surgery and Emergency Medicine, Washington University at St. Louis, St. Louis (T.M.O.).
Tiffany M Osborn
G Sarah Power
David A Harrison
M Zia Sadique
Richard D Grieve
Rahi Jahan
Sheila E Harvey
Derek Bell
Julian F Bion
Timothy J Coats
Mervyn Singer
J Duncan Young
Kathryn M Rowan
ProMISe Trial Investigators
Intensive Care National Audit & Research Centre · GBLondon School of Hygiene & Tropical Medicine · GBChelsea and Westminster Hospital NHS Foundation Trust · GBUniversity College London · GBUniversity of Birmingham · GBUniversity of Leicester · GBUniversity of Oxford · GBWashington University in St. Louis · US

Funding

Department of Health 07/37/47Department of Health SRF-2013-06-016
6 · The paper itself

Abstract

backgroundEarly, goal-directed therapy (EGDT) is recommended in international guidelines for the resuscitation of patients presenting with early septic shock. However, adoption has been limited, and uncertainty about its effectiveness remains.

methodsWe conducted a pragmatic randomized trial with an integrated cost-effectiveness analysis in 56 hospitals in England. Patients were randomly assigned to receive either EGDT (a 6-hour resuscitation protocol) or usual care. The primary clinical outcome was all-cause mortality at 90 days.

resultsWe enrolled 1260 patients, with 630 assigned to EGDT and 630 to usual care. By 90 days, 184 of 623 patients (29.5%) in the EGDT group and 181 of 620 patients (29.2%) in the usual-care group had died (relative risk in the EGDT group, 1.01; 95% confidence interval [CI], 0.85 to 1.20; P=0.90), for an absolute risk reduction in the EGDT group of -0.3 percentage points (95% CI, -5.4 to 4.7). Increased treatment intensity in the EGDT group was indicated by increased use of intravenous fluids, vasoactive drugs, and red-cell transfusions and reflected by significantly worse organ-failure scores, more days receiving advanced cardiovascular support, and longer stays in the intensive care unit. There were no significant differences in any other secondary outcomes, including health-related quality of life, or in rates of serious adverse events. On average, EGDT increased costs, and the probability that it was cost-effective was below 20%.

conclusionsIn patients with septic shock who were identified early and received intravenous antibiotics and adequate fluid resuscitation, hemodynamic management according to a strict EGDT protocol did not lead to an improvement in outcome. (Funded by the United Kingdom National Institute for Health Research Health Technology Assessment Programme; ProMISe Current Controlled Trials number, ISRCTN36307479.).

Indexed as

Blood TransfusionFluid TherapyAdultAgedAnti-Bacterial AgentsClinical ProtocolsCombined Modality TherapyCost-Benefit AnalysisFemaleHumansInfusions, IntravenousKaplan-Meier EstimateMaleMiddle AgedPractice Guidelines as TopicQuality-Adjusted Life YearsAnti-Bacterial AgentsVasoconstrictor Agents

Identifiers

PMID25776532
OpenAlexW2098019283

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

and 3 more above

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.