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Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill — (BICAR-ICU)  

Metabolic Acidosis Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02476253
Study type Interventional
Source University Hospital, Montpellier
Contact
Status Completed
Phase Phase 3
Start date May 5, 2015
Completion date May 29, 2017
View Details
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