SODium BICarbonate for Metabolic Acidosis in the ICU (NCT05697770) | Clinical Trial Compass
Active ā Not RecruitingPhase 3
SODium BICarbonate for Metabolic Acidosis in the ICU
Australia500 participantsStarted 2023-04-26
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Adults (ā„ 18 years);
ā. 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);
ā. A dedicated intravenous line (central or peripheral) is available (or insertion of such a line is planned within the next hour); and
ā. Metabolic acidosis, defined as:
ā. pH \< 7.30; and
ā. BE ā¤ -4 mEq/L; and
ā. PaCO2 ā¤ 45 mmHg for non-intubated patients or PaCO2 ā¤ 50 mmHg for intubated patients.
Exclusion criteria
ā. Fulfilled all eligibility criteria greater than 48 hours ago; or
ā. 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
ā. DKA; or
ā. Estimated glomerular filtration rate (eGFR) \< 30 mL/min due to chronic kidney disease; or
ā. Currently receiving sodium bicarbonate at the moment of randomisation (doses of sodium bicarbonate prior to randomisation are allowed); or
ā. Currently receiving RRT (acute or chronic) or planned to start RRT in the next 3 hours (according to the treating clinical team); or
What they're measuring
1
MAKE30 score
Timeframe: 30 days or at hospital discharge (whichever occurs first)
Trial details
NCT IDNCT05697770
SponsorAustralian and New Zealand Intensive Care Research Centre