Serpa Neto, A

Fujii, T

McNamara, M

Moore, J

Young, P

Peake, S

Bailey, M

Hodgson, C

Higgins, A

See, E

Secombe, Paul

Campbell, Lewis

Young, M

Maeda, M

Pilcher, D

Nichol, A

Deane, A

Licari, E

White, K

French, C

Shehabi, Y

Cross, A

Maiden, M

Kadam, U

El Khawas, K

Cooper, J

Bellomo, R

Udy, A

2023-06-09

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 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.

Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.

Department of Critical Care, Melbourne Medical School, University of Melbourne, Austin Hospital, Melbourne, Australia.

Data Analytics Research and Evaluation (DARE) Centre, Austin Hospital, Melbourne, Australia.

Department of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil.

Intensive Care Unit, The Jikei University School of Medicine, Tokyo, Japan.

Intensive Care Unit, Wellington Hospital, Wellington, New Zealand.

Medical Research Institute of New Zealand, Wellington, New Zealand.

Department of Intensive Care Medicine, The Queen Elizabeth Hospital, Woodville South, Australia.

Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia.

Department of Intensive Care Medicine, Austin Hospital, Melbourne, Australia.

Intensive Care Unit Alice Springs Hospital, Alice Springs, Australia.

College of Medicine and Public Health, Flinders University, Bedford Park, Australia.

The Australian and New Zealand Intensive Care Society (ANZICS) Centre for Outcome and Resource Evaluation (CORE), Melbourne, Australia.

Intensive Care Unit, Royal Darwin Hospital, Darwin, Australia.

Department of Intensive Care and Hyperbaric Medicine, The Alfred Hospital, Melbourne, Australia.

Department of Pharmacy, St. Marianna University School of Medicine Hospital, Kawasaki, Japan.

Intensive Care Unit, Royal Melbourne Hospital, Melbourne, Victoria, Australia.

Intensive Care Unit, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.

Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia.

Department of Medicine, Western Health, Melbourne Medical School, The University of Melbourne, Melbourne, Victoria, Australia.

Department of Intensive Care, Western Health, Melbourne, Victoria, Australia.

Monash University, School of Clinical Sciences, Clayton, Victoria, Australia.

Intensive Care Services, Monash Health, Clayton, Victoria, Australia.

Intensive Care, University of New South Wales, Kensington Campus, School of Clinical Medicine, Sydney, New South Wales, Australia.

Department of Intensive Care Medicine, Northern Health, Epping, Victoria, Australia.

Centre for Integrated Critical Care, University of Melbourne, Parkville, Victoria, Australia.

Intensive Care Unit, University Hospital Geelong, Barwon Health, Geelong, Victoria, Australia.

Intensive Care Unit, Royal Adelaide Hospital, Adelaide, South Australia, Australia.

Department of Intensive Care Medicine, Werribee Mercy Hospital, Werribee, Victoria, Australia.

Department of Intensive Care Medicine, Monash Health Casey Hospital, Berwick, Victoria, Australia.

Department of Intensive Care Medicine, Epworth Hospital Geelong, Waurn Ponds, Victoria, Australia.

Intensive Care Unit, Grampians Health, Ballarat, Victoria, Australia.

Crit Care Med . 2023 Nov 1;51(11):e221-e233. doi: 10.1097/CCM.0000000000005955. Epub 2023 Jun 9.

https://pubmed.ncbi.nlm.nih.gov/37294139/?otool=iaurydwlib

https://hdl.handle.net/10137/12477

Sodium Bicarbonate for Metabolic Acidosis in the ICU: Results of a Pilot Randomized Double-Blind Clinical Trial.

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