6/27/23, 11:43 PM BICAR-ICU Pathway Feedback Search Clinical Topics Home Studies BICAR ICU BICAR ICU Disease Metabolic acidosis 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 38.8% female N = 400 61.2% male 400 patients (151 female, 238 male) Inclusion criteria: adult patients admitted to the ICU within 48 hours experiencing severe acidemia and a total Sequential Organ Failure Assessment 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 https://web.pathway.md/studies/recjbv8hbMdJ0MOla 1/2 6/27/23, 11:43 PM BICAR-ICU Pathway 71.0 % 71 66 53.3 % 35.5 % 17.8 % No significant difference 0.0 % Bicarbonate Control 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) 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 Sequential Organ Failure Assessment 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. Open reference URL https://web.pathway.md/studies/recjbv8hbMdJ0MOla 2/2