Clinical trial NCT02476253: Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill
Official title: Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill : A Multiple Center Randomized Clinical Trial (BICAR-ICU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metabolic Acidosis
Keywords: acidosis
shock
sodium bicarbonate
renal replacement therapy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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)

Primary outcomes:
measure: Composite criteria of Day 28 mortality and/or patients with at least one organ failure defined as a SOFA score of 3 or 4
timeFrame: Day 0 to Day 28
Secondary outcomes:
measure: Evolution of the organ failure scores
timeFrame: Day 0 to Day 28
measure: Duration of renal replacement therapy (days)
timeFrame: Day 0 to Day 28
measure: Duration of mechanical ventilation and ventilatory free days (days)
timeFrame: Day 0 to Day 28
measure: Duration of vasopressors administration (h)
timeFrame: Day 0 to Day 28
measure: Hospital acquired infections (incidence)
timeFrame: Day 0 to Day 28
measure: Amount of intravenous fluid (ml)
timeFrame: Day 0 to Day 2
Other outcomes:
Locations:
city: Montpellier
country: France
facility: DAR St Eloi
Study officials:
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