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

University Hospital Center (CHU)

Status and phase

Completed

Phase 3

Conditions

Metabolic Acidosis

Treatments

Drug: Sodium Bicarbonate

Study type

Interventional

Funder types

Other

Identifiers

NCT02476253

9260

Details and patient eligibility

About

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.

Full 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

Enrollment

400 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

Administration of Sodium Bicarbonate 24 hours before inclusion
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)