Evidence map›Paper›PMID 25072757›Full record

Trial reportCritical care medicine2014

Simplified severe sepsis protocol: a randomized controlled trial of modified early goal-directed therapy in Zambia.

Ben Andrews, Levy Muchemwa, Paul Kelly, Shabir Lakhi, Douglas C Heimburger, Gordon R Bernard

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Critical care medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 99 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
99citing papers in PubMed, 12 pooled it
13.5field-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.

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

99 citing papers in PubMed, 12 syntheses or guidelines pooled it, 192 citations in OpenAlex.

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  14. Restrictive fluids versus standard care in adults with sepsis in the emergency department (REFACED): A multicenter, randomized feasibility trial.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2022
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39 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Ben Andrews1Institute for Global Health, Vanderbilt University, Nashville, TN. 2Division of General Internal Medicine and Public Health, Department of Internal Medicine, Vanderbilt University, Nashville, TN. 3Department of Internal Medicine, University of Zambia School of Medicine, Lusaka, Zambia. 4Barts and the London School of Medicine, London, United Kingdom. 5Department of Internal Medicine, University Teaching Hospital, Lusaka, Zambia. 6Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University, Nashville, TN.
Levy Muchemwa
Paul Kelly
Shabir Lakhi
Douglas C Heimburger
Gordon R Bernard
University of Zambia · ZM

Funding

The Vanderbilt Institute for Clinical and Translational Research (VICTR)UL1TR000445 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BERNARD, GORDON RAPHAEL · 2012 to 2016
$41.4M
Fogarty International Clinical Research Scholars Support Center @ Vanderbilt-AAMCR24TW007988 · FIC · VANDERBILT UNIVERSITY · PI VERMUND, STEN H. · 2007 to 2011
$27.6M
Vanderbilt-Emory-Cornell-Duke Global Health Fellowship Consortium-Expanding Diversity for Global Equity (EDGE)D43TW009337 · FIC · VANDERBILT UNIVERSITY MEDICAL CENTER · PI ALIYU, MUKTAR HASSAN, HEIMBURGER, DOUGLAS CORBETT · 2017 to 2021
$6.3M
FIC NIH HHS D43 TW009337FIC NIH HHS R24 TW007988NCATS NIH HHS UL1 TR000445
6 · The paper itself

Abstract

objectiveTo assess the efficacy of a simple, goal-directed sepsis treatment protocol for reducing mortality in patients with severe sepsis in Zambia.

designSingle-center nonblinded randomized controlled trial.

settingEmergency department, ICU, and medical wards of the national referral hospital in Lusaka, Zambia. PATIENTS: One hundred twelve patients enrolled within 24 hours of admission with severe sepsis, defined as systemic inflammatory response syndrome with suspected infection and organ dysfunction

interventions: Simplified Severe Sepsis Protocol consisting of up to 4 L of IV fluids within 6 hours, guided by jugular venous pressure assessment, and dopamine and/or blood transfusion in selected patients. Control group was managed as usual care. Blood cultures were collected and early antibiotics administered for both arms. MEASUREMENTS AND MAIN

resultsPrimary outcome was in-hospital all-cause mortality. One hundred nine patients were included in the final analysis and 88 patients (80.7%) were HIV positive. Pulmonary infections were the most common source of sepsis. In-hospital mortality rate was 64.2% in the intervention group and 60.7% in the control group (relative risk, 1.05; 95% CI, 0.79-1.41). Mycobacterium tuberculosis complex was isolated from 31 of 82 HIV-positive patients (37.8%) with available mycobacterial blood culture results. Patients in Simplified Severe Sepsis Protocol received significantly more IV fluids in the first 6 hours (2.7 L vs 1.7 L, p = 0.002). The study was stopped early because of high mortality rate among patients with hypoxemic respiratory failure in the intervention arm (8/8, 100%) compared with the control arm (7/10, 70%; relative risk, 1.43; 95% CI, 0.95-2.14).

conclusionFactors other than tissue hypoperfusion probably account for much of the end-organ dysfunction in African patients with severe sepsis. Studies of fluid-based interventions should utilize inclusion criteria to accurately capture patients with hypovolemia and tissue hypoperfusion who are most likely to benefit from fluids. Exclusion of patients with severe respiratory distress should be considered when ventilatory support is not readily available.

Indexed as

Hospital MortalityAdultAnti-Bacterial AgentsBlood TransfusionCombined Modality TherapyCritical CareDeveloping CountriesDopamineEmergency Service, HospitalFemaleFluid TherapyHumansIntensive Care UnitsMaleMiddle AgedPilot ProjectsAnti-Bacterial AgentsDopamine

Identifiers

PMID25072757
PMCPMC4199893
OpenAlexW2089830179

What OpenQuestion holds

Textmetadata
LicenceTDM
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.