Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill

Study Overview
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Brief Summary
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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
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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

Official Title
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Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill : A Multiple Center Randomized Clinical Trial (BICAR-ICU)

Conditions
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Metabolic Acidosis

Intervention / Treatment
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* Drug: Sodium Bicarbonate


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30 | Drug: Sodium Bicarbonate<br>* Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30<br>|
| No Intervention: Control<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite criteria of Day 28 mortality and/or patients with at least one organ failure defined as a SOFA score of 3 or 4 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the organ failure scores | use of SOFA score to assess the outcome 2 | Day 0 to Day 28 | 
| Duration of renal replacement therapy (days) | need to renal replacement therapy | Day 0 to Day 28 | 
| Duration of mechanical ventilation and ventilatory free days (days) | duration of mechanical ventilation and ventilatory free days | Day 0 to Day 28 | 
| Duration of vasopressors administration (h) | need for vasopressors and fluids using duration of vasopressor infusion (D0 to D28) | Day 0 to Day 28 | 
| Hospital acquired infections (incidence) | hospital acquired infections using United States Centers for Disease Control definitions and a dedicated document | Day 0 to Day 28 | 
| Amount of intravenous fluid (ml) |  | Day 0 to Day 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acidosis, shock, sodium bicarbonate, renal replacement therapy