Evidence map›Paper›PMID 27686349›Full record

Trial reportIntensive care medicine2016

Restricting volumes of resuscitation fluid in adults with septic shock after initial management: the CLASSIC randomised, parallel-group, multicentre feasibility trial.

Peter B Hjortrup, Nicolai Haase, Helle Bundgaard, Simon L Thomsen, Robert Winding, Ville Pettilä, Anne Aaen, David Lodahl, Rasmus E Berthelsen, Henrik Christensen and 6 more

2 registry-linked trialsOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Intensive care medicine, 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 177 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
177citing papers in PubMed, 18 pooled it
30.3field-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.

NCT02079402 phase4completednot on this map

Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care (CLASSIC) - a Randomised Clinical Trial

TypeinterventionalSponsorAnders PernerRan2014 to 2015Enrolled153ConditionsSeptic Shock, SepsisArmsIsotonic crystalloids
NCT03668236 phase4completednot on this mapstarted 2018, after this paper: background citation

The Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care Trial

TypeinterventionalSponsorAnders Perner, MD, PhDRan2018 to 2022Enrolled1,554ConditionsSeptic ShockArmsIsotonic crystalloids
3 · Its place in the literature

Who cites it

177 citing papers in PubMed, 18 syntheses or guidelines pooled it, 392 citations in OpenAlex.

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  13. [S3 Guideline Sepsis-prevention, diagnosis, therapy, and aftercare : Long version].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2020
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117 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 7 institutions in 2 countries.

Peter B HjortrupDepartment of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Nicolai HaaseDepartment of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Helle BundgaardDepartment of Intensive Care, Randers Hospital, Randers, Denmark.
Simon L ThomsenDepartment of Intensive Care, Aalborg University Hospital, Aalborg, Denmark.
Robert WindingDepartment of Intensive Care, Herning Hospital, Herning, Denmark.
Ville PettiläDepartment of Intensive Care, Helsinki University Hospital, Helsinki, Finland.
Anne AaenDepartment of Intensive Care, Holbæk Hospital, Holbæk, Denmark.
David LodahlDepartment of Intensive Care, Holstebro Hospital, Holstebro, Denmark.
Rasmus E BerthelsenDepartment of Intensive Care, Nordsjællands Hospital, Hillerød, Denmark.
Henrik ChristensenDepartment of Intensive Care, Herlev Hospital, Herlev Municipality, Denmark.
Martin B MadsenDepartment of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Per WinkelCopenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Jørn WetterslevCopenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Anders PernerDepartment of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark. anders.perner@regionh.dk.
CLASSIC Trial Group
Scandinavian Critical Care Trials Group
Copenhagen University Hospital · DKAalborg University Hospital · DKHerlev Hospital · DKRegionshospitalet Herning · DKHelsinki University Hospital · FINordsjællands Hospital · DKRegional Hospital Randers · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe assessed the effects of a protocol restricting resuscitation fluid vs. a standard care protocol after initial resuscitation in intensive care unit (ICU) patients with septic shock.

methodsWe randomised 151 adult patients with septic shock who had received initial fluid resuscitation in nine Scandinavian ICUs. In the fluid restriction group fluid boluses were permitted only if signs of severe hypoperfusion occurred, while in the standard care group fluid boluses were permitted as long as circulation continued to improve.

resultsThe co-primary outcome measures, resuscitation fluid volumes at day 5 and during ICU stay, were lower in the fluid restriction group than in the standard care group [mean differences -1.2 L (95 % confidence interval -2.0 to -0.4); p < 0.001 and -1.4 L (-2.4 to -0.4) respectively; p < 0.001]. Neither total fluid inputs and balances nor serious adverse reactions differed statistically significantly between the groups. Major protocol violations occurred in 27/75 patients in the fluid restriction group. Ischaemic events occurred in 3/75 in the fluid restriction group vs. 9/76 in the standard care group (odds ratio 0.32; 0.08-1.27; p = 0.11), worsening of acute kidney injury in 27/73 vs. 39/72 (0.46; 0.23-0.92; p = 0.03), and death by 90 days in 25/75 vs. 31/76 (0.71; 0.36-1.40; p = 0.32).

conclusionsA protocol restricting resuscitation fluid successfully reduced volumes of resuscitation fluid compared with a standard care protocol in adult ICU patients with septic shock. The patient-centred outcomes all pointed towards benefit with fluid restriction, but our trial was not powered to show differences in these exploratory outcomes.

trial registrationNCT02079402.

Indexed as

AgedBlood CirculationCritical CareFeasibility StudiesFemaleFluid TherapyHumansIntensive Care UnitsMaleMiddle AgedOdds RatioResuscitationShock, SepticWater-Electrolyte BalanceCritical careFluid therapyIntensive careResuscitationSepsisSepticShock

Identifiers

PMID27686349
OpenAlexW2508264804

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.