Evidence map›Paper›PMID 23075127›Full record

Trial reportThe New England journal of medicine2012

Hydroxyethyl starch or saline for fluid resuscitation in intensive care.

John A Myburgh, Simon Finfer, Rinaldo Bellomo, Laurent Billot, Alan Cass, David Gattas, Parisa Glass, Jeffrey Lipman, Bette Liu, Colin McArthur and 6 more

Erratum issued 4 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 4 registered trials, which are not on this map. Cited by 498 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
498citing papers in PubMed, 11 pooled it
119.8field-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.

NCT00935168 phase3completednot on this map

A Multi-centre Randomized Controlled Trial of Fluid Resuscitation With Starch (6%Hydroxyethyl Starch 130/0.4) Compared to Saline (0.9% Sodium Chloride) in Intensive Care Patients on Mortality

TypeinterventionalSponsorThe George InstituteRan2009 to 2012Enrolled7,000ConditionsIntensive CareArms6% Hydroxy-ethyl starch (130/0.4), Saline
NCT01849757 nawithdrawnnot on this mapstarted 2013, after this paper: background citation

Comparison of Priming Constituents in Patients Undergoing CPB Assisted Cardiac Surgery: HES 130/0.4 or Albumin 5%

TypeinterventionalSponsorUniversity of SaskatchewanRan2013 to 2017Enrolled0ConditionsCoronary Artery Disease, Aortic Valve Disease, Mitral Valve DiseaseArmsprime crystalloid, Human Albumin, Voluven
NCT04058236 phase4unknown statusnot on this mapstarted 2019, after this paper: background citation

Glycocalyx Levels in Patients Undergoing Pancreatectomy With Human Albumin 5% vs. Gelofusine

TypeinterventionalSponsorUniversity of MalayaRan2019 to 2021Enrolled20ConditionsEndothelial Degeneration, Pancreatic Cancer, Pancreatectomy, Postoperative Pancreatic FistulaArmshuman albumin 5%, gelofusine.
NCT04567433 completednot on this mapstarted 2020, after this paper: background citation

Days Alive and Out of Hospital for Patients With Sepsis

TypeobservationalSponsorThe George Institute for Global Health, AustraliaRan2020 to 2024Enrolled6,213ConditionsSepsis, Septic ShockArmsHydroxyethyl starch, Hydrocortisone, Early Goal Directed Therapy
3 · Its place in the literature

Who cites it

498 citing papers in PubMed, 11 syntheses or guidelines pooled it, 1,684 citations in OpenAlex.

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  9. Perioperative Clinical Trials in AKI.Seminars in nephrology · 2020
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438 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 8 institutions in 3 countries.

John A MyburghDivision of Critical Care and Trauma, George Institute for Global Health, Sydney, NSW, Australia. jmyburgh@georgeinstitute.org.au
Simon Finfer
Rinaldo Bellomo
Laurent Billot
Alan Cass
David Gattas
Parisa Glass
Jeffrey Lipman
Bette Liu
Colin McArthur
Shay McGuinness
Dorrilyn Rajbhandari
Colman B Taylor
Steven A R Webb
CHEST Investigators
Australian and New Zealand Intensive Care Society Clinical Trials Group
The University of Sydney · AUAuckland City Hospital · NZUNSW Sydney · AURoyal North Shore Hospital · AURoyal Perth Hospital · AURoyal Prince Alfred Hospital · AUThe University of Melbourne · AUThe University of Queensland · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe safety and efficacy of hydroxyethyl starch (HES) for fluid resuscitation have not been fully evaluated, and adverse effects of HES on survival and renal function have been reported.

methodsWe randomly assigned 7000 patients who had been admitted to an intensive care unit (ICU) in a 1:1 ratio to receive either 6% HES with a molecular weight of 130 kD and a molar substitution ratio of 0.4 (130/0.4, Voluven) in 0.9% sodium chloride or 0.9% sodium chloride (saline) for all fluid resuscitation until ICU discharge, death, or 90 days after randomization. The primary outcome was death within 90 days. Secondary outcomes included acute kidney injury and failure and treatment with renal-replacement therapy.

resultsA total of 597 of 3315 patients (18.0%) in the HES group and 566 of 3336 (17.0%) in the saline group died (relative risk in the HES group, 1.06; 95% confidence interval [CI], 0.96 to 1.18; P=0.26). There was no significant difference in mortality in six predefined subgroups. Renal-replacement therapy was used in 235 of 3352 patients (7.0%) in the HES group and 196 of 3375 (5.8%) in the saline group (relative risk, 1.21; 95% CI, 1.00 to 1.45; P=0.04). In the HES and saline groups, renal injury occurred in 34.6% and 38.0% of patients, respectively (P=0.005), and renal failure occurred in 10.4% and 9.2% of patients, respectively (P=0.12). HES was associated with significantly more adverse events (5.3% vs. 2.8%, P<0.001).

conclusionsIn patients in the ICU, there was no significant difference in 90-day mortality between patients resuscitated with 6% HES (130/0.4) or saline. However, more patients who received resuscitation with HES were treated with renal-replacement therapy. (Funded by the National Health and Medical Research Council of Australia and others; CHEST ClinicalTrials.gov number, NCT00935168.).

Indexed as

AdultAgedCreatinineCritical CareCritical IllnessFemaleFluid TherapyHospital MortalityHumansHydroxyethyl Starch DerivativesIntensive Care UnitsIntention to Treat AnalysisKidney DiseasesMaleMiddle AgedResuscitationCreatinineHydroxyethyl Starch DerivativesSodium Chloride

Identifiers

PMID23075127
OpenAlexW2170344041

What OpenQuestion holds

Textmetadata
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.