Overview

SODium BICarbonate for Metabolic Acidosis in the ICU

Status:
Not yet recruiting

Trial end date:
2027-06-01

Target enrollment:
0

Participant gender:
All

Summary

This trial aims to assess if, among adults in the ICU with metabolic acidosis, an infusion of sodium bicarbonate diluted in 5% dextrose, compared with an infusion of 5% dextrose, reduces Major Adverse Kidney Events within 30 days of randomization.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Australian and New Zealand Intensive Care Research Centre

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.

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.