drugset / Trial / NCT04010630

Sodium Bicarbonate for the Treatment of Severe Metabolic Acidosis With Moderate or Severe Acute Kidney Injury in ICU

NCT04010630

Completed 640 enrolled University Hospital, Montpellier
RandomizedParallel-groupOpen-labelOther

Summary

Severe metabolic acidemia in the critically ill (pH equal or less than 7.20; PaCO2 equal or less than 45mmHg and bicarbonate concentration equal or less than of 20 mmol/l) is associated with a 50% rate of day 28 mortality. Moderate to severe acute kidney injury is a frequent cause of metabolic acidemia in the critically ill. When both severe metabolic acidemia and moderate to severe acute kidney injury are observed, day 28 mortality is approximatively 55-60%. Severe acidemia has been shown to be a biomarker of severity but may also contribute by itself to outcome. Investigators recently performed a multiple center randomised clinical trial (BICARICU-1) that suggests that sodium bicarbonate infusion titrated to maintain the pH equal or more than 7.30 is associated with a higher survival rate (secondary endpoint) in patients presenting both severe metabolic acidemia and moderate to severe acute kidney injury patients. Whether sodium bicarbonate infusion may improve long term survival (Day 90, primary outcome) in these severe acute kidney injury patients is currently unknown.

Timeline

Start
2019-10-07
Primary completion
2023-12-19
Completion
2024-06-17

Drugs

EvaluationDrugModalityDoseRoute
Subject sodium bicarbonate Diagnostic / imaging agent 4.2 % Intravenous
Subject sodium bicarbonate Diagnostic / imaging agent 125 ml Intravenous
Subject sodium bicarbonate Diagnostic / imaging agent 250 ml Intravenous
Subject sodium bicarbonate Diagnostic / imaging agent 1000 ml Intravenous