Evidence map›Paper›PMID 34547081›Full record

Trial reportJAMA2021

Effect of Slower vs Faster Intravenous Fluid Bolus Rates 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, Murillo S C Assunção, Ary Serpa-Neto and 23 more

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report 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 22 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 4 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

22 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Review
  7. Review
  8. Article
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  11. Article
  12. Review
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  14. Article
  15. Article
  16. How I personalize fluid therapy in septic shock?Critical care (London, England) · 2023
    Review
  17. Article
  18. Article
  19. Fluid bolus therapy in pediatric sepsis: a narrative review.European journal of medical research · 2022
    Review
  20. Review
4 · The record

Corrections and comments

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 (BRICNet), São Paulo, Brazil.
Rodrigo S BiondiBrazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil.
Flávio G R FreitasBrazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil.
Viviane C VeigaBrazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil.
Rodrigo C FigueiredoHospital Maternidade São José, Centro Universitário do Espírito Santo (UNESC), 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.
Murillo S C AssunçãoHospital Israelita Albert Einstein, São Paulo, Brazil.
Ary Serpa-NetoBrazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil.
Jorge L R ParanhosSanta Casa de Misericórdia de São João Del Rei, São João Del Rei, Brazil.
José AndradeHospital Geral de Vitória da Conquista, Vitória da Conquista, Brazil.
Michele M G GodoyHospital das Clínicas da Universidade Federal de Pernambuco, Recife, Brazil.
Edson RomanoHCor, São Paulo, Brazil.
Felipe Dal PizzolBrazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil.
Emerson B SilvaHospital Geral de Caxias do Sul, Caxias do Sul, Brazil.
Miqueias M L SilvaHospital SAMUR, Vitória da Conquista, Brazil.
Miriam C V MachadoCentro Hospitar UNIMED, Joinville, Brazil.
Luiz Marcelo S MalbouissonHospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
Airton L O ManoelHospital Paulistano, São Paulo, Brazil.
Marlus M ThompsonHospital Evangélico Cachoeiro do Itapemirim, Cachoeiro do Itapemirim, Brazil.
Lanese M FigueiredoHospital Distrital Doutor Evandro Ayres de Moura, Fortaleza, 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.
Eliana V SantucciHCor Research Institute, São Paulo, Brazil.
Thiago D CorrêaBrazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil.
Luciano C P AzevedoBrazilian Research in Intensive Care Network (BRICNet), 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 B 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

Importance: Slower intravenous fluid infusion rates could reduce the formation of tissue edema and organ dysfunction in critically ill patients; however, there are no data to support different infusion rates during fluid challenges for important outcomes such as mortality. Objective: To determine the effect of a slower infusion rate vs control infusion rate on 90-day survival in patients in the intensive care unit (ICU). Design, Setting, and Participants: Unblinded randomized factorial clinical trial in 75 ICUs in Brazil, involving 11 052 patients requiring at least 1 fluid challenge and with 1 risk factor for worse outcomes were randomized from May 29, 2017, to March 2, 2020. Follow-up was concluded on October 29, 2020. Patients were randomized to 2 different infusion rates (reported in this article) and 2 different fluid types (balanced fluids or saline, reported separately). Interventions: Patients were randomized to receive fluid challenges at 2 different infusion rates; 5538 to the slower rate (333 mL/h) and 5514 to the control group (999 mL/h). Patients were also randomized to receive balanced solution or 0.9% saline using a factorial design. Main Outcomes and Measures: The primary end point was 90-day survival. Results: Of all randomized patients, 10 520 (95.2%) were analyzed (mean age, 61.1 years [SD, 17.0 years]; 44.2% were women) after excluding duplicates and consent withdrawals. Patients assigned to the slower rate received a mean of 1162 mL on the first day vs 1252 mL for the control group. By day 90, 1406 of 5276 patients (26.6%) in the slower rate group had died vs 1414 of 5244 (27.0%) in the control group (adjusted hazard ratio, 1.03; 95% CI, 0.96-1.11; P = .46). There was no significant interaction between fluid type and infusion rate (P = .98). Conclusions and Relevance: Among patients in the intensive care unit requiring fluid challenges, infusing at a slower rate compared with a faster rate did not reduce 90-day mortality. These findings do not support the use of a slower infusion rate. Trial Registration: ClinicalTrials.gov Identifier: NCT02875873.

Indexed as

AdultAgedCritical IllnessFemaleFluid TherapyHospital MortalityHumansInfusions, IntravenousIntensive Care UnitsMaleMiddle AgedProportional Hazards Models

Identifiers

PMID34547081
PMCPMC8356145

What OpenQuestion holds

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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.