Sodium Bicarbonate for Metabolic Acidosis in the ICU: Results of a Pilot Randomized Double-Blind Clinical Trial.
Crit Care Med
; 51(11): e221-e233, 2023 11 01.
Article
en En
| MEDLINE
| ID: mdl-37294139
ABSTRACT
OBJECTIVES:
To identify the best population, design of the intervention, and to assess between-group biochemical separation, in preparation for a future phase III trial.DESIGN:
Investigator-initiated, parallel-group, pilot randomized double-blind trial.SETTING:
Eight ICUs in Australia, New Zealand, and Japan, with participants recruited from April 2021 to August 2022. PATIENTS Thirty patients greater than or equal to 18 years, within 48 hours of admission to the ICU, receiving a vasopressor, and with metabolic acidosis (pH < 7.30, base excess [BE] < -4 mEq/L, and Pa co2 < 45 mm Hg).INTERVENTIONS:
Sodium bicarbonate or placebo (5% dextrose). MEASUREMENTS AND MAINRESULT:
The primary feasibility aim was to assess eligibility, recruitment rate, protocol compliance, and acid-base group separation. The primary clinical outcome was the number of hours alive and free of vasopressors on day 7. The recruitment rate and the enrollment-to-screening ratio were 1.9 patients per month and 0.13 patients, respectively. Time until BE correction (median difference, -45.86 [95% CI, -63.11 to -28.61] hr; p < 0.001) and pH correction (median difference, -10.69 [95% CI, -19.16 to -2.22] hr; p = 0.020) were shorter in the sodium bicarbonate group, and mean bicarbonate levels in the first 24 hours were higher (median difference, 6.50 [95% CI, 4.18 to 8.82] mmol/L; p < 0.001). Seven days after randomization, patients in the sodium bicarbonate and placebo group had a median of 132.2 (85.6-139.1) and 97.1 (69.3-132.4) hours alive and free of vasopressor, respectively (median difference, 35.07 [95% CI, -9.14 to 79.28]; p = 0.131). Recurrence of metabolic acidosis in the first 7 days of follow-up was lower in the sodium bicarbonate group (3 [20.0%] vs. 15 [100.0%]; p < 0.001). No adverse events were reported.CONCLUSIONS:
The findings confirm the feasibility of a larger phase III sodium bicarbonate trial; eligibility criteria may require modification to facilitate recruitment.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Acidosis
/
Bicarbonato de Sodio
Tipo de estudio:
Clinical_trials
/
Guideline
/
Prognostic_studies
Límite:
Humans
País/Región como asunto:
Oceania
Idioma:
En
Revista:
Crit Care Med
Año:
2023
Tipo del documento:
Article
País de afiliación:
Australia