Hierarchical endpoint analysis using win ratio in critical care: An exploration using the balanced solutions in intensive care study (BaSICS)

Zampieri, Fernando G.; Damiani, Lucas Petri; Biondi, Rodrigo Santos; Freitas, Flávio Geraldo Rezende; Veiga, Viviane Cordeiro; Figueiredo, Rodrigo Cruvinel; Neto, Ary Serpa; Manoel, Airton L O; Miranda, Tamiris Abait; Corrêa, Thiago Domingos; Azevedo, Luciano César Pontes; Silva, Nilton B.; Machado, Flávia Ribeiro; Cavalcanti, Alexandre Biasi

doi:10.1016/j.jcrc.2022.154113

Cited by 9 publications

(12 citation statements)

References 17 publications

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“…The Balanced Solutions in Intensive Care Study (BaSICS), a double-blind, factorial, randomized clinical trial was conducted to assess whether administration of a balanced solution (Plasma-Lyte 148) during intensive care unit (ICU) stay, compared with saline solution, would result in improved 90-day survival in critically ill patients.…”

Section: Introductionmentioning

confidence: 99%

Effect of Intravenous Fluid Treatment With a Balanced Solution vs 0.9% Saline Solution on Mortality in Critically Ill Patients

Zampieri¹,

Machado

Biondi

et al. 2021

JAMA

128

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for the BaSICS investigators and the BRICNet members IMPORTANCE Intravenous 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.OBJECTIVE To 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 PARTICIPANTS Double-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).INTERVENTIONS Patients 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 MEASURESThe primary outcome was 90-day survival. RESULTS Among 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.

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Section: Introductionmentioning

confidence: 99%

Effect of Intravenous Fluid Treatment With a Balanced Solution vs 0.9% Saline Solution on Mortality in Critically Ill Patients

Zampieri¹,

Machado

Biondi

et al. 2021

JAMA

128

View full text Add to dashboard Cite

show abstract

“…Details on the inclusion and exclusion criteria in the BaSICS trial can be found in the main publication ( 4 ) and protocol. ( 8 ) In brief, patients requiring at least one fluid challenge with risk factors for acute kidney injury and without a discharge plan in the next 24 hours were considered for inclusion in the trial. The study assessed both the effects of fluid type and two different infusion rates for fluid bolus; this secondary analysis considers only the fluid type analysis.…”

Section: Methodsmentioning

confidence: 99%

Effects of balanced solution on short-term outcomes in traumatic brain injury patients: a secondary analysis of the BaSICS randomized trial

Zampieri¹,

Damiani²,

Biondi³

et al. 2022

Revista Brasileira De Terapia Intensiva

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Objective To describe the effects of balanced solution use on the short-term outcomes of patients with traumatic brain injury enrolled in BaSICS trial. Methods Patients were randomized to receive either 0.9% saline or balanced solution during their intensive care unit stay. The primary endpoint was 90-day mortality, and the secondary outcomes were days alive and free of intensive care unit stay at 28 days. The primary endpoint was assessed using Bayesian logistic regression. The secondary endpoint was assessed using a Bayesian zero-inflated beta binomial regression. Results We included 483 patients (236 in the 0.9% saline arm and 247 in the balanced solution arm). A total of 338 patients (70%) with a Glasgow coma scale score ≤ 12 were enrolled. The overall probability that balanced solutions were associated with higher 90-day mortality was 0.98 (OR 1.48; 95%CrI 1.04 - 2.09); this mortality increment was particularly noticeable in patients with a Glasgow coma scale score below 6 at enrollment (probability of harm of 0.99). Balanced solutions were associated with -1.64 days alive and free of intensive care unit at 28 days (95%CrI -3.32 - 0.00) with a probability of harm of 0.97. Conclusion There was a high probability that balanced solutions were associated with high 90-day mortality and fewer days alive and free of intensive care units at 28 days. ClinicalTrials.gov: NCT02875873

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“…This clinical trial was conducted at 75 ICUs in Brazil. The study protocol and statistical analysis plan were published before analyses began and are available in Supplement 1 and Supplement 2, respectively. All patients or their next of kin provided written informed consent.…”

Section: Methodsmentioning

confidence: 99%

“…The Balanced Solutions in Intensive Care Study (BaSICS), a factorial trial that evaluated whether a slower fluid bolus rate (333 mL/h) vs control rate (999 mL/h), was conducted to assess whether slower infusion rates would be associated with improved 90-day survival in critically ill patients.…”

Section: Introductionmentioning

confidence: 99%

Effect of Slower vs Faster Intravenous Fluid Bolus Rates on Mortality in Critically Ill Patients

Zampieri

Machado

Biondi

et al. 2021

JAMA

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for the BaSICS investigators and the BRICNet members 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 MEASURESThe 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.

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Hierarchical endpoint analysis using win ratio in critical care: An exploration using the balanced solutions in intensive care study (BaSICS)

Cited by 9 publications

References 17 publications

Effect of Intravenous Fluid Treatment With a Balanced Solution vs 0.9% Saline Solution on Mortality in Critically Ill Patients

Effect of Intravenous Fluid Treatment With a Balanced Solution vs 0.9% Saline Solution on Mortality in Critically Ill Patients

Effects of balanced solution on short-term outcomes in traumatic brain injury patients: a secondary analysis of the BaSICS randomized trial

Effect of Slower vs Faster Intravenous Fluid Bolus Rates on Mortality in Critically Ill Patients

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