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Not Yet Recruiting NCT05697770

SODium BICarbonate for Metabolic Acidosis in the ICU

Conditions: Metabolic Acidosis, Shock

Sex: All
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 500
Sponsor: Australian and New Zealand Intensive Care Research Centre

Location: Australia

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.

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.Adults (≥ 18 years);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);A dedicated intravenous line (central or peripheral) is available (or insertion of such a line is planned within the next hour); andMetabolic acidosis, defined as:pH < 7.30; andBE ≤ -4 mEq/L; andPaCO2 ≤ 45 mmHg.Exclusion Criteria:Fulfilled all eligibility criteria greater than 48 hours ago; orSuspected 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); orDKA; orEstimated glomerular filtration rate (eGFR) < 30 mL/min due to chronic kidney disease; orCurrently receiving sodium bicarbonate at the moment of randomisation (doses of sodium bicarbonate prior to randomisation are allowed); orCurrently receiving RRT (acute or chronic) or planned to start RRT in the next 3 hours (according to the treating clinical team); orSevere dysnatraemia (serum Na ≥ 155 mEq/L or < 120 mEq/L); orHypokalaemia (serum K < 2.5 mEq/L); orPulmonary oedema with PaO2 / FiO2 < 100; orHypocalcaemia (iCa < 0.8mmol/L); orPatients admitted to the ICU after a drug overdose or intoxication (including alcohol intoxication); orPregnancy or breastfeeding; orDeath 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; orPatients with a life expectancy < 30 days due to a chronic or underlying medical condition; orConsidered to be at high risk of cerebral oedema by the treating clinician (e.g. traumatic brain injury or acute brain disease); orClinician believes that being enrolled in intervention or control arm is not in the best interest of the patient; orPrevious enrolment in this study.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05697770). StuddyBuddy aggregates publicly available trial information.