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Randomized Controlled Trial
. 2021 Sep 7;326(9):830-838.
doi: 10.1001/jama.2021.11444.

Effect of Slower vs Faster Intravenous Fluid Bolus Rates on Mortality in Critically Ill Patients: The BaSICS Randomized Clinical Trial

Fernando G Zampieri  1   2 , Flávia R Machado  2   3 , Rodrigo S Biondi  2   4 , Flávio G R Freitas  2   5 , Viviane C Veiga  2   6 , Rodrigo C Figueiredo  7 , Wilson J Lovato  8 , Cristina P Amêndola  9 , Murillo S C Assunção  10 , Ary Serpa-Neto  2   10 , Jorge L R Paranhos  11 , José Andrade  12 , Michele M G Godoy  13 , Edson Romano  14 , Felipe Dal Pizzol  2   15 , Emerson B Silva  16 , Miqueias M L Silva  17 , Miriam C V Machado  18 , Luiz Marcelo S Malbouisson  19 , Airton L O Manoel  20 , Marlus M Thompson  21 , Lanese M Figueiredo  22 , Rafael M Soares  1 , Tamiris A Miranda  1 , Lucas M de Lima  1 , Eliana V Santucci  1 , Thiago D Corrêa  2   10 , Luciano C P Azevedo  2   23 , John A Kellum  24 , Lucas P Damiani  1 , Nilton B Silva  25 , Alexandre B Cavalcanti  1   2 ; BaSICS investigators and the BRICNet members
Collaborators, Affiliations
Randomized Controlled Trial

Effect of Slower vs Faster Intravenous Fluid Bolus Rates on Mortality in Critically Ill Patients: The BaSICS Randomized Clinical Trial

Fernando G Zampieri et al. JAMA. .

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Zampieri reported receiving grants from Ionis Pharmaceuticals US and Bactiguard Sweden. Dr Veiga reported receiving personal fees from Aspen and Pfizer. Dr Serpa-Neto reported receiving personal fees from Drager. Dr Azevedo reported receiving lecture fees from Pfizer and Baxter, consulting fees from Halex-Istar, and research grants from Ache Pharmaceutical. Dr Kellum reported receiving grants and personal fees from Baxter. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flow Chart of the BaSICS Trial of Critically Ill Patients Requiring Fluid Infusions
aThere was no screening log in the trial; therefore, the number of patients assessed for eligibility are not presented.
Figure 2.
Figure 2.. Cumulative Incidence of the Primary End Point (90-Day Survival) for Slower vs Control Infusion Rates
Median observation time was 90 days (interquartile range [IQR], 57-90 days) for the control and 90 days (IQR, 55-90 days) for the slower infusion rate.
Figure 3.
Figure 3.. Patient Status According to Whether Patients Were Discharged, Dead, or in the Intensive Care Unit (ICU) With Cardiovascular Sequential Organ Failure Score (SOFA)
The cardiovascular SOFA is scored so that patiens are given the highest score that fits their clinical characteristic. The total number in each column for the slow rate group is 5276 patients and 5244 for the control rate.
See this image and copyright information in PMC

Comment in

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