Journal article
Sodium Bicarbonate for Metabolic Acidosis in the ICU: Results of a Pilot Randomized Double-Blind Clinical Trial
A Serpa Neto, T Fujii, M McNamara, J Moore, PJ Young, S Peake, M Bailey, C Hodgson, AM Higgins, EJ See, P Secombe, L Campbell, M Young, M Maeda, D Pilcher, A Nichol, A Deane, E Licari, K White, C French Show all
Critical Care Medicine | LIPPINCOTT WILLIAMS & WILKINS | Published : 2023
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 Paco2 45 mm Hg). INTERVENTIONS: Sodium bicarbonate or placebo (5% dextrose). MEASUREMENTS AND MAIN RESULT: The primary feasibili..
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Funding Acknowledgements
Dr. Higgins' institution received funding from the National Health and Medical Research Council (NHMRC) investigator grant. Dr. Young disclosed government work. Dr. Maeda disclosed work for hire. Dr. French disclosed the off-label product use of Sodium bicarbonate in critical illness. Dr. Cooper's institution received funding from the NHMRC of Australia and Eustralis Pharmaceuticals Pty Ltd (Pressura Neuro). Dr. Udy disclosed that he received trial consumables from Integra Lifesciences. The remaining authors have disclosed that they do not have any potential conflicts of interest.