Clinical Trial: Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill : A Multiple Center Randomized Clinical Trial (BICAR-ICU)
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 Summary:
- 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
Sponsor: University Hospital, Montpellier
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Evolution of the organ failure scores [ Time Frame: Day 0 to Day 28 ]use of SOFA score to assess the outcome 2
- Duration of renal replacement therapy (days) [ Time Frame: Day 0 to Day 28 ]need to renal replacement therapy
- Duration of mechanical ventilation and ventilatory free days (days) [ Time Frame: Day 0 to Day 28 ]duration of mechanical ventilation and ventilatory free days
- Duration of vasopressors administration (h) [ Time Frame: Day 0 to Day 28 ]need for vasopressors and fluids using duration of vasopressor infusion (D0 to D28)
- Hospital acquired infections (incidence) [ Time Frame: 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) [ Time Frame: Day 0 to Day 2 ]
Original Secondary Outcome: Same as current
Information By: University Hospital, Montpellier
Dates:
Date Received: June 10, 2015
Date Started: May 5, 2015
Date Completion: October 13, 2017
Last Updated: April 20, 2017
Last Verified: March 2017