Metabolic Acidosis
Conditions
Keywords
acidosis, shock, sodium bicarbonate, renal replacement therapy
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
Interventions
DRUGSodium Bicarbonate
Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Evolution of the organ failure scores | Day 0 to Day 28 | use of SOFA score to assess the outcome 2 |
| Duration of renal replacement therapy (days) | Day 0 to Day 28 | need to renal replacement therapy |
| 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) |
| 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 | — |
Countries
France
Outcome results
None listed