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