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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30
DAR St Eloi
Montpellier, France
Composite criteria of Day 28 mortality and/or patients with at least one organ failure defined as a SOFA score of 3 or 4
Composite criteria of Day 28 mortality and/or patients with at least one organ failure defined as a SOFA score of 3 or 4
Time frame: Day 0 to Day 28
Evolution of the organ failure scores
use of SOFA score to assess the outcome 2
Time frame: Day 0 to Day 28
Duration of renal replacement therapy (days)
need to renal replacement therapy
Time frame: Day 0 to Day 28
Duration of mechanical ventilation and ventilatory free days (days)
duration of mechanical ventilation and ventilatory free days
Time frame: Day 0 to Day 28
Duration of vasopressors administration (h)
need for vasopressors and fluids using duration of vasopressor infusion (D0 to D28)
Time frame: Day 0 to Day 28
Hospital acquired infections (incidence)
hospital acquired infections using United States Centers for Disease Control definitions and a dedicated document
Time frame: Day 0 to Day 28
Amount of intravenous fluid (ml)
Time frame: Day 0 to Day 2
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