BaSICS
Trial question
Is a balanced solution superior to 0.9% saline solution in critically ill patients requiring fluid challenges?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 10520
10520 patients (4650 female, 5870 male).
Inclusion criteria: critically ill patients requiring fluid administration with ≥ 1 risk factors for worse outcomes.
Key exclusion criteria: AKI treated or expected to require RRT within the next 6 hours, severe electrolyte disturbance, imminent death within 24 hours, brain death, receipt of palliative care.
Interventions
N=5522 balanced solution (Plasma-Lyte).
N=5530 saline solution (0.9% sodium chloride).
Primary outcome
Deaths at day 90
26.4%
27.2%
27.2 %
20.4 %
13.6 %
6.8 %
0.0 %
Balanced
solution
Saline
solution
No significant
difference ↔
No significant difference in deaths at day 90 (26.4% vs. 27.2%; aHR 0.97, 95% CI 0.9 to 1.05).
Secondary outcomes
No significant difference in need for RRT in the hospital (7.5% vs. 8.1%; OR 0.93, 95% CI 0.81 to 1.06).
No significant difference in AKI with KDIGO stage ≥ 2 at day 7 (23.4% vs. 23.3%; OR 1.07, 95% CI 0.88 to 1.3).
No significant difference in hospital length of stay (8 days vs. 9 days; AD -0.3 days, 95% CI -1.1 to 0.5).
Conclusion
In critically ill patients requiring fluid administration with ≥ 1 risk factors for worse outcomes, balanced solution was not superior to saline solution with respect to deaths at day 90.
Reference
Fernando G Zampieri, Flávia R Machado, Rodrigo S Biondi et al. 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. JAMA. 2021 Aug 10;326(9):1-12.
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