Evidence map›Paper›PMID 34375394›Full record

ArticleJAMA2021

Effect of Intravenous Fluid Treatment With a Balanced Solution vs 0.9% Saline Solution on Mortality in Critically Ill Patients: The BaSICS Randomized Clinical Trial.

Fernando G Zampieri, Flávia R Machado, Rodrigo S Biondi, Flávio G R Freitas, Viviane C Veiga, Rodrigo C Figueiredo, Wilson J Lovato, Cristina P Amêndola, Ary Serpa-Neto, Jorge L R Paranhos and 23 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in JAMA, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02875873 (Balanced Solution Versus Saline in Intensive Care Study), which is not on this map. Cited by 129 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
129citing papers in PubMed, 15 pooled it
–field-weighted citation impact
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.

NCT02875873 phase3completednot on this map

Balanced Solution Versus Saline in Intensive Care Study

TypeinterventionalSponsorHospital do CoracaoRan2017 to 2021Enrolled11,075ConditionsCritical Illness, Acute Kidney InjuryArmsPlasma-Lyte, Saline 0.9%, Slow infusion speed, Fast Infusion Speed
3 · Its place in the literature

Who cites it

129 citing papers in PubMed, 15 syntheses or guidelines pooled it.

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  2. [S3 guideline on sepsis-prevention, diagnosis, therapy, and follow-up care-update 2025].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2025
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  18. Time Course of Kidney Injury Biomarkers in Children With Septic Shock: Nested Cohort Study Within the Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis Trial.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2025
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69 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

33 authors.

Fernando G ZampieriHCor Research Institute, São Paulo, Brazil.
Flávia R MachadoBrazilian Research in Intensive Care Network, São Paulo, Brazil.
Rodrigo S BiondiBrazilian Research in Intensive Care Network, São Paulo, Brazil.
Flávio G R FreitasBrazilian Research in Intensive Care Network, São Paulo, Brazil.
Viviane C VeigaBrazilian Research in Intensive Care Network, São Paulo, Brazil.
Rodrigo C FigueiredoHospital Maternidade São José, Centro Universitário do Espírito Santo, Colatina, Brazil.
Wilson J LovatoHospital das Clínicas, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, Brazil.
Cristina P AmêndolaFundação Pio XII, Hospital de Câncer de Barretos, Barretos, Brazil.
Ary Serpa-NetoBrazilian Research in Intensive Care Network, São Paulo, Brazil.
Jorge L R ParanhosSanta Casa de Misericórdia de São João Del Rei, São João Del Rei, Brazil.
Marco A V GuedesHospital Ana Nery, Salvador, Brazil.
Eraldo A LúcioHospital São Francisco, Santa Casa de Porto Alegre, Porto Alegre, Brazil.
Lúcio C Oliveira-JúniorHospital Geral Clériston Andrade, Feira de Santana, Brazil.
Thiago C LisboaBrazilian Research in Intensive Care Network, São Paulo, Brazil.
Fábio H LacerdaHospital da Luz, São Paulo, Brazil.
Israel S MaiaBrazilian Research in Intensive Care Network, São Paulo, Brazil.
Cintia M C GrionBrazilian Research in Intensive Care Network, São Paulo, Brazil.
Murillo S C AssunçãoHospital Israelita Albert Einstein, São Paulo, Brazil.
Airton L O ManoelHospital Paulistano, São Paulo, Brazil.
João M Silva-JuniorHospital do Servidor Público Estadual, São Paulo, Brazil.
Péricles DuarteHospital Universitário de Cascavel, Cascavel, Brazil.
Rafael M SoaresHCor Research Institute, São Paulo, Brazil.
Tamiris A MirandaHCor Research Institute, São Paulo, Brazil.
Lucas M de LimaHCor Research Institute, São Paulo, Brazil.
Rodrigo M GurgelHCor Research Institute, São Paulo, Brazil.
Denise M PaisaniHCor Research Institute, São Paulo, Brazil.
Thiago D CorrêaBrazilian Research in Intensive Care Network, São Paulo, Brazil.
Luciano C P AzevedoBrazilian Research in Intensive Care Network, São Paulo, Brazil.
John A KellumCenter for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.
Lucas P DamianiHCor Research Institute, São Paulo, Brazil.
Nilton Brandão da SilvaSchool of Medicine, Federal University of Health Sciences, Porto Alegre, Brazil.
Alexandre B CavalcantiHCor Research Institute, São Paulo, Brazil.
BaSICS investigators and the BRICNet members

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

importanceIntravenous fluids are used for almost all intensive care unit (ICU) patients. Clinical and laboratory studies have questioned whether specific fluid types result in improved outcomes, including mortality and acute kidney injury.

objectiveTo determine the effect of a balanced solution vs saline solution (0.9% sodium chloride) on 90-day survival in critically ill patients. DESIGN, SETTING, AND

participantsDouble-blind, factorial, randomized clinical trial conducted at 75 ICUs in Brazil. Patients who were admitted to the ICU with at least 1 risk factor for worse outcomes, who required at least 1 fluid expansion, and who were expected to remain in the ICU for more than 24 hours were randomized between May 29, 2017, and March 2, 2020; follow-up concluded on October 29, 2020. Patients were randomized to 2 different fluid types (a balanced solution vs saline solution reported in this article) and 2 different infusion rates (reported separately).

interventionsPatients were randomly assigned 1:1 to receive either a balanced solution (n = 5522) or 0.9% saline solution (n = 5530) for all intravenous fluids. MAIN OUTCOMES AND MEASURES: The primary outcome was 90-day survival.

resultsAmong 11 052 patients who were randomized, 10 520 (95.2%) were available for the analysis (mean age, 61.1 [SD, 17] years; 44.2% were women). There was no significant interaction between the 2 interventions (fluid type and infusion speed; P = .98). Planned surgical admissions represented 48.4% of all patients. Of all the patients, 60.6% had hypotension or vasopressor use and 44.3% required mechanical ventilation at enrollment. Patients in both groups received a median of 1.5 L of fluid during the first day after enrollment. By day 90, 1381 of 5230 patients (26.4%) assigned to a balanced solution died vs 1439 of 5290 patients (27.2%) assigned to saline solution (adjusted hazard ratio, 0.97 [95% CI, 0.90-1.05]; P = .47). There were no unexpected treatment-related severe adverse events in either group. CONCLUSION AND RELEVANCE: Among critically ill patients requiring fluid challenges, use of a balanced solution compared with 0.9% saline solution did not significantly reduce 90-day mortality. The findings do not support the use of this balanced solution.

trial registrationClinicalTrials.gov Identifier: NCT02875873.

Identifiers

PMID34375394
PMCPMC8356144

What OpenQuestion holds

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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.