Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill

• Status: Unknown status
• Trial end date: 2017-10-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Montpellier

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)