BICAR-ICU
Trial question
What is the role of sodium bicarbonate therapy among ICU patients with severe metabolic acidemia?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
39.0% female
61.0% male
N = 389
389 patients (151 female, 238 male).
Inclusion criteria: adult patients admitted to the ICU within 48 hours experiencing severe acidemia and a total SOFA score ≥ 4 or an arterial lactate concentration ≥ 2 mmol/L.
Key exclusion criteria: respiratory acidosis, proven digestive or urinary tract loss of sodium bicarbonate, stage IV CKD, ketoacidosis, and sodium bicarbonate infusion within 24 h before the screening.
Interventions
N=195 bicarbonate (4.2% of intravenous sodium bicarbonate infusion).
N=194 control (no sodium bicarbonate).
Primary outcome
Death from any cause by day 28 and presence of at least one organ failure at day 7
66%
71%
71.0 %
53.3 %
35.5 %
17.8 %
0.0 %
Bicarbonate
Control
No significant
difference ↔
No significant difference in death from any cause by day 28 and the presence of at least one organ failure at day 7 (66% vs. 71%; ARD -5.5, 95% CI -15.2 to 4.2).
Secondary outcomes
Significant decrease in death by day 28 and the presence of at least one organ failure at day 7 in patients with AKI scores of 2-3 (70% vs. 82%; ARD -12.3, 95% CI -26 to -0.1).
Significant increase in RRT-free days during ICU stay (19 days vs. 8 days).
No significant difference in dependence on dialysis at ICU discharge (22% vs. 34%; ARD -12.5, 95% CI -34.3 to 9.3).
Safety outcomes
No significant difference in ICU-acquired infections.
Significant difference in RRT during ICU stay (35% vs. 52%).
Conclusion
In adult patients admitted to the ICU within 48 hours experiencing severe acidemia and a total SOFA score ≥ 4 or an arterial lactate concentration ≥ 2 mmol/L, bicarbonate was not superior to control with respect to death from any cause by day 28 and the presence of at least one organ failure at day 7.
Reference
Samir Jaber, Catherine Paugam, Emmanuel Futier et al. Sodium bicarbonate therapy for patients with severe metabolic acidaemia in the intensive care unit (BICAR-ICU): a multicentre, open-label, randomised controlled, phase 3 trial. Lancet. 2018 Jul 7;392(10141):31-40.
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