Using sodium bicarbonate to treat metabolic acidosis in ICU patients

SODium BICarbonate for Metabolic Acidosis in the Intensive Care Unit (SODa-BIC): a Multicentre, Randomised, Double-blind Clinical Trial

This study is testing if giving sodium bicarbonate to critically ill ICU patients with metabolic acidosis can help prevent serious kidney problems compared to a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Australian and New Zealand Intensive Care Research Centre (Academic / other)
• Locations: 27 sites (Garran, Australian Capital Territory and 26 other locations)
• Trial ID: NCT05697770 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of sodium bicarbonate infusion compared to a placebo (5% dextrose) in adults with metabolic acidosis in the ICU. The study aims to determine if sodium bicarbonate can reduce Major Adverse Kidney Events within 30 days of treatment. It is a Phase 3, international, multicenter, double-blind, randomized trial involving patients who are critically ill and receiving vasopressor support. Participants must meet specific criteria for metabolic acidosis and be admitted to the ICU within 48 hours.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are in the ICU with metabolic acidosis and receiving vasopressor therapy.

Not a fit: Patients who do not have metabolic acidosis or are not receiving vasopressor support may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce kidney complications in critically ill patients with metabolic acidosis.

How similar studies have performed: Previous studies on sodium bicarbonate have shown variable results, making this approach both relevant and necessary to explore further.

Eligibility criteria

Inclusion Criteria:

All the diagnostic criteria of metabolic acidosis below have to be fulfilled within the last 2 hours before randomisation (pH, PaCO2 and BE from the same blood gas), and a vasopressor is being infused continuously at the time of randomization.

1. Adults (≥ 18 years);
2. Receiving a continuous infusion of a vasopressor to maintain mean arterial pressure \> 65 mmHg (or a mean arterial pressure target set by the treating clinician);
3. A dedicated intravenous line (central or peripheral) is available (or insertion of such a line is planned within the next hour); and
4. Metabolic acidosis, defined as:

   1. pH \< 7.30; and
   2. BE ≤ -4 mEq/L; and
   3. PaCO2 ≤ 45 mmHg for non-intubated patients or PaCO2 ≤ 50 mmHg for intubated patients.

Exclusion Criteria:

1. Fulfilled all eligibility criteria greater than 48 hours ago; or
2. Suspected clinically significant digestive or urinary tract loss of sodium bicarbonate (e.g., diarrhoea, ileostomy losses, renal tubular acidosis, or drainage of pancreatic or bile duct); or
3. DKA; or
4. Estimated glomerular filtration rate (eGFR) \< 30 mL/min due to chronic kidney disease; or
5. Currently receiving sodium bicarbonate at the moment of randomisation (doses of sodium bicarbonate prior to randomisation are allowed); or
6. Currently receiving RRT (acute or chronic) or planned to start RRT in the next 3 hours (according to the treating clinical team); or
7. Severe dysnatraemia (serum Na ≥ 155 mEq/L or \< 120 mEq/L); or
8. Hypokalaemia (serum K \< 2.5 mEq/L); or
9. Pulmonary oedema with PaO2 / FiO2 \< 100; or
10. Hypocalcaemia (iCa \< 0.8mmol/L); or
11. Patients admitted to the ICU after a drug overdose or intoxication (including alcohol intoxication); or
12. Pregnancy or breastfeeding; or
13. Death is deemed to be inevitable as a result of the current acute illness and either the treating clinician, the patient or the substitute decision maker are not committed to full active treatment; or
14. Patients with a life expectancy \< 30 days due to a chronic or underlying medical condition; or
15. Considered to be at high risk of cerebral oedema by the treating clinician (e.g. traumatic brain injury or acute brain disease); or
16. Clinician believes that being enrolled in intervention or control arm is not in the best interest of the patient; or
17. Previous enrolment in this study.

Where this trial is running

Garran, Australian Capital Territory and 26 other locations

• Canberra Hospital — Garran, Australian Capital Territory, Australia (Recruiting)
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (Recruiting)
• St Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia (Recruiting)
• Gosford Hospital — Gosford, New South Wales, Australia (Recruiting)
• Calvary Mater Newcastle — Waratah, New South Wales, Australia (Recruiting)
• Royal Darwin Hospital — Tiwi, Northern Territory, Australia (Recruiting)
• Cairns Hospital — Cairns, Queensland, Australia (Recruiting)
• Queen Elizabeth II Jubilee Hospital — Coopers Plains, Queensland, Australia (Recruiting)
• Royal Brisbane and Women's Hospital — Herston, Queensland, Australia (Recruiting)
• Mater Hospital — South Brisbane, Queensland, Australia (Recruiting)
• Princess Alexandra Hopsital — Woolloongabba, Queensland, Australia (Recruiting)
• Royal Adelaide Hospital — Adelaide, South Australia, Australia (Recruiting)
• Flinders Medical Centre — Bedford Park, South Australia, Australia (Recruiting)
• The Queen Elizabeth Hospital — Woodville, South Australia, Australia (Recruiting)
• Grapmians Health — Ballarat, Victoria, Australia (Recruiting)
• Casey Hospital — Berwick, Victoria, Australia (Recruiting)
• Footscray Hospital — Footscray, Victoria, Australia (Recruiting)
• Frankston Hospital — Frankston, Victoria, Australia (Recruiting)
• The Austin Hospital — Heidelberg, Victoria, Australia (Recruiting)
• Peninsula Private Hospital — Langwarrin, Victoria, Australia (Recruiting)
• The Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
• Epworth — Richmond, Victoria, Australia (Recruiting)
• Sunshine Hospital — St Albans, Victoria, Australia (Recruiting)
• Auckland City Hospital — Auckland, New Zealand (Recruiting)
• Christchurch Hospital — Christchurch, New Zealand (Recruiting)
• Wellington Regional Hospital — Wellington, New Zealand (Recruiting)
• Sultan Qaboos Comprehensive Cancer Care and Research Center — Seeb, Oman (Recruiting)

Study contacts

• Principal investigator: Ary Serpa Neto, PhD — ANZIC RC, Monash university
• Study coordinator: Mairead McNamara

Conditions Metabolic Acidosis; Shock; Sodium bicarbonate; Metabolic acidosis; Clinical trial