Evidence map›Paper›PMID 22624531›Full record

Trial reportCritical care (London, England)2012

Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 vs. 0.9% NaCl fluid replacement in patients with severe sepsis: the CRYSTMAS study.

Bertrand Guidet, Olivier Martinet, Thierry Boulain, Francois Philippart, Jean François Poussel, Julien Maizel, Xavier Forceville, Marc Feissel, Michel Hasselmann, Alexandra Heininger and 1 more

2 registry-linked trialsOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Critical care (London, England), 2012. 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 120 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
120citing papers in PubMed, 13 pooled it
37.0field-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.

NCT00464204 phase3completednot on this map

Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis

TypeinterventionalSponsorFresenius KabiRan2007 to 2010Enrolled196ConditionsSepsisArms6 % Hydroxyethylstarch 130/0.4 = "Voluven®", 0.9 % NaCl
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
3 · Its place in the literature

Who cites it

120 citing papers in PubMed, 13 syntheses or guidelines pooled it, 341 citations in OpenAlex.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 8 institutions in 3 countries.

Bertrand Guidet
Olivier Martinet
Thierry Boulain
Francois Philippart
Jean François Poussel
Julien Maizel
Xavier Forceville
Marc Feissel
Michel Hasselmann
Alexandra Heininger
Hugo Van Aken
Hôpital Civil, Strasbourg · FRCentre hospitalier régional d'Orléans · FRHôpital Nord · FRImation (United States) · USSorbonne Université · FRUniversitätsklinikum Tübingen · DEUniversité Paris Cité · FRUniversity of Münster · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionInadequate initial treatment and delayed hemodynamic stabilization (HDS) may be associated with increased risk of death in severe sepsis patients.

methodsIn order to compare the hemodynamic efficacy and safety of 6% HES 130/0.4 and NaCl 0.9% for HDS in patients with severe sepsis, we designed a prospective, multicenter, active-controlled, double-blind, randomized study in intensive care units.

results174 out of 196 patients reached HDS (88 and 86 patients for HES and NaCl, respectively). Significantly less HES was used to reach HDS vs. NaCl (1,379 ± 886 ml in the HES group and 1,709 ± 1,164 ml in the NaCl group (mean difference = -331 ± 1,033, 95% CI -640 to -21, P = 0.0185). Time to reach HDS was 11.8 10.1 hours vs. 14.3 ± 11.1 hours for HES and NaCl, respectively. Total quantity of study drug infused over four consecutive days, ICU and hospital LOS, and area under the curve of SOFA score were comparable. Acute renal failure occurred in 24 (24.5%) and 19 (20%) patients for HES and NaCl, respectively (P = 0.454). There was no difference between AKIN and RIFLE criteria among groups and no difference in mortality, coagulation, or pruritus up to 90 days after treatment initiation.

conclusionSignificantly less volume was required to achieve HDS for HES vs. NaCl in the initial phase of fluid resuscitation in severe sepsis patients without any difference for adverse events in both groups. CLINICALTRIALSGOV: NCT00464204.

Indexed as

AgedAged, 80 and overDouble-Blind MethodFemaleFluid TherapyHemodynamicsHumansHydroxyethyl Starch DerivativesMaleMiddle AgedProspective StudiesSepsisSodium ChlorideTreatment OutcomeHES 130-0.4Hydroxyethyl Starch DerivativesSodium Chloride

Identifiers

PMID22624531
PMCPMC3580640
OpenAlexW2116065793

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.