NCT02476253

Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill

Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill : A Multiple Center Randomized Clinical Trial (BICAR-ICU)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the present study is to compare the adjunct treatment of metabolic or mixed severe acidosis in the critically ill using Sodium Bicarbonate as a buffer to increase the plasma pH vs no buffering therapy. The study is a randomized multiple center clinical trial with the outcome as a primary endpoint.

Detailed description

* Design: randomized multiple center clinical trial, open label * Arms: intravenous 4.2% Sodium Bicarbonate vs no additional treatment * Inclusion: age of 18 yo or above, critically ill patient with a SOFA score of 4 or above, lactatemia of 2mmol/l or above, with pH of 7.20 or below and PaCO2 of 45mmHg or below and bicarbonatemia of 20mmol/l or below * Exclusion: single respiratory disorder (PaCO2 \> 50 mmHg, Bicarbonatemia equal or higher than (PaCO2-40)/10 + 24 ; acute diarrhea, ileostomy or biliary drainage ; stage IV kidney failure or chronic dialysis ; tubular acidosis, ketoacidosis, high anion gap acids poisoning (PEG, aspirin, methanol) ; PaCO2 equal to 45mmHg or above and spontaneous breathing, pregnancy, protected patients, moribund patient (life expectancy of 48h or below) * Randomization: website randomization with stratification on age, presence of sepsis at inclusion, renal failure * Intervention: experimental arm: intravenous 4.2% Sodium Bicarbonate 125 to 250ml in 30min up to 1000ml/24h. The target is a plasma pH of 7.30 or above. * An interim statistical analysis is planned when 200 patients will be included

Conditions

• Metabolic Acidosis

Interventions

Type	Name	Description
DRUG	Sodium Bicarbonate	Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30

Timeline

• Start date: 2015-05-05
• Primary completion: 2017-05-29
• Completion: 2017-05-29
• First posted: 2015-06-19
• Last updated: 2024-05-29

Locations

1 site across 1 country: France