Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill
- Registration Number
- NCT02476253
- Lead Sponsor
- University Hospital, Montpellier
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Sodium Bicarbonate Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30
- Primary Outcome Measures
Name Time Method Composite criteria of Day 28 mortality and/or patients with at least one organ failure defined as a SOFA score of 3 or 4 Day 0 to Day 28 Composite criteria of Day 28 mortality and/or patients with at least one organ failure defined as a SOFA score of 3 or 4
- Secondary Outcome Measures
Name Time Method Evolution of the organ failure scores Day 0 to Day 28 use of SOFA score to assess the outcome 2
Duration of mechanical ventilation and ventilatory free days (days) Day 0 to Day 28 duration of mechanical ventilation and ventilatory free days
Duration of vasopressors administration (h) Day 0 to Day 28 need for vasopressors and fluids using duration of vasopressor infusion (D0 to D28)
Duration of renal replacement therapy (days) Day 0 to Day 28 need to renal replacement therapy
Hospital acquired infections (incidence) Day 0 to Day 28 hospital acquired infections using United States Centers for Disease Control definitions and a dedicated document
Amount of intravenous fluid (ml) Day 0 to Day 2
Trial Locations
- Locations (1)
DAR St Eloi
🇫🇷Montpellier, France