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 ]

Composite criteria of Day 28 mortality and/or patients with at least one organ failure defined as a SOFA score of 3 or 4


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