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

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.

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

PURPOSE: To reanalyze the results of the Balanced Solutions in Intensive Care Study (BaSICS) through hierarchical endpoint analysis with win ratio. METHODS: All patients with full data in BaSICS trial were elected for the analysis. BaSICS compared balanced solutions (Plasma Lye 148) versus 0.9% saline in critically ill patients requiring fluid challenge. The win ratio was defined as a hierarchical endpoint of 90-day mortality, recepit of kidney replacement therapy, hospital length-of-stay (LOS), and intensive care unit (ICU) LOS. Both unstratified and stratified (by admission type: planned admission, unplanned admission with sepsis, and unplanned admission without sepsis) approaches were used. A subgroup analysis was performed in patients with traumatic brain injury. RESULTS: A total of 10,490 patients were included in the analysis, resulting in 27,587,566 unique combinations for unstratified WR. Unstratified Win ratio was 1.02 (95% confidence interval 0.97; 1.07), which was similar to stratified WR. No stratum in the stratified analysis resulted in significant results. Subgroup analysis confirmed the possible harm of balanced solutions in traumatic brain injury patients (WR 0.80; 95% confidence interval 0.64; 0.99). CONCLUSION: In this reanalysis of BaSICS, a win ratio analysis largely replicated the results of the main trial, yielding neutral results except for the subgroup of patients with traumatic brain injury where a signal of harm was found.

Early determinants of death due to multiple organ failure after noncardiac surgery in high-risk patients.

BACKGROUND: Prediction of perioperative cardiac complications is important in the medical management of patients undergoing noncardiac surgery. However, these patients frequently die as a consequence of primary or secondary multiple organ failure (MOF), often as a result of sepsis. We investigated the early perioperative risk factors for in-hospital death due to MOF in surgical patients. METHODS: This was a prospective, multicenter, observational cohort study performed in 21 Brazilian intensive care units (ICUs). Adult patients undergoing noncardiac surgery who were admitted to the ICU within 24 hours after operation were evaluated. MOF was characterized by the presence of at least 2 organ failures. To determine the relative risk (RR) of in-hospital death due to MOF, we performed a logistic regression multivariate analysis. RESULTS: A total of 587 patients were included (mean age, 62.4 ± 17 years). ICU and hospital mortality rates were 15% and 20.6%, respectively. The main cause of death was MOF (53%). Peritonitis (RR 4.17, 95% confidence interval [CI] 1.38-12.6), diabetes (RR 3.63, 95% CI 1.17-11.2), unplanned surgery (RR 3.62, 95% CI 1.18-11.0), age (RR 1.04, 95% CI 1 0.01-1.08), and elevated serum lactate concentrations (RR 1.52, 95% CI 1.14-2.02), a high central venous pressure (RR 1.12, 95% CI 1.04-1.22), a fast heart rate (RR 3.63, 95% CI 1.17-11.2) and pH (RR 0.04, 95% CI 0.0005-0.38) on the day of admission were independent predictors of death due to MOF. CONCLUSIONS: MOF is the main cause of death after surgery in high-risk patients. Awareness of the risk factors for death due to MOF may be important in risk stratification and can suggest routes for therapy.