Long-Term Outcome of Severe Metabolic Acidemia in ICU Patients, a BICAR-ICU Trial Post Hoc Analysis

Abstract

Long-term prognosis of ICU survivors is a major issue. Severe acidemia upon ICU admission is associated with very high short-term mortality. Since the long-term prognosis of these patients is unknown, we aimed to determine the long-term health-related quality of life and survival of these patients. DESIGN:Post hoc analysis of a multicenter, randomized, controlled trial. SETTING: Twenty-six French ICUs.PATIENTS: Day 28 critically ill survivors admitted with severe acidemia and enrolled in the BICAR-ICU trial. INTERVENTION:Sodium bicarbonate versus no sodium bicarbonate infusion according to the randomization group. MEASUREMENTS AND MAIN RESULTS:The primary outcome was healthrelated quality of life (HRQoL) measured with the 36-item Short Form Health Survey and the EuroQol 5-D questionnaires. Secondary outcomes were mortality, end-stage renal disease treated with renal replacement therapy or renal transplantation, place of residence, professional status, and ICU readmission. HRQoL was reduced with no significant difference between the two groups. HRQoL was reduced particularly in the role-physical health domain (64/100 ± 41 in the control group and 49/100 ± 43 in the bicarbonate group, p = 0.28), but it was conserved in the emotional domains (96/100 ± 19 in the control group and 86/100 ± 34 in the bicarbonate group, p = 0.44). Forty percent of the survivors described moderate to severe problems walking, and half of the survivors described moderate to severe problems dealing with usual activities. Moderate to severe anxiety or depression symptoms were present in one third of the survivors. Compared with the French general population, HRQoL was decreased in the survivors mostly in the physical domains. The 5-year overall survival rate was 30% with no significant difference between groups. CONCLUSIONS:Long-term HRQoL was decreased in both the control and the sodium bicarbonate groups of the BICAR-ICU trial and was lower than the general population, especially in the physical domains.

Sodium bicarbonate for the treatment of severe metabolic acidosis with moderate or severe acute kidney injury in the critically ill: protocol for a randomised clinical trial (BICARICU-2)

“…Based on the BICARICU-1 trial where day 90 mortality was 81% in the control group and 64% in the bicarbonate group (post hoc analysis of BICARICU-1 trial, 17 ) in the population of interest for the BICARICU-2 trial (severe metabolic acidosis and severe acute kidney injury in the critically ill patients), we calculated that a total of 588 patients would be needed for 80% power to show an absolute between-groups difference of 10% in the primary outcome (day 90 all-cause mortality) at a two-sided alpha level of 0.05 (overall p value for the trial), assuming that the administration of bicarbonate would be associated with a day 90 mortality of 70% vs 80% in the control group. Assuming less than 8% non-analyzable patients (lost to follow-up or consent withdrawal; the same rate as in the BICARICU-1 trial), we plan to enrol 640 patients.…”