Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill ((BICAR-ICU))
Primary Purpose
Metabolic Acidosis
Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Sodium Bicarbonate
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Acidosis focused on measuring acidosis, shock, sodium bicarbonate, renal replacement therapy
Eligibility 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)
Sites / Locations
- DAR St EloiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30
No intervention
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Evolution of the organ failure scores
use of SOFA score to assess the outcome 2
Duration of renal replacement therapy (days)
need to renal replacement therapy
Duration of mechanical ventilation and ventilatory free days (days)
duration of mechanical ventilation and ventilatory free days
Duration of vasopressors administration (h)
need for vasopressors and fluids using duration of vasopressor infusion (D0 to D28)
Hospital acquired infections (incidence)
hospital acquired infections using United States Centers for Disease Control definitions and a dedicated document
Amount of intravenous fluid (ml)
Full Information
NCT ID
NCT02476253
First Posted
June 10, 2015
Last Updated
April 20, 2017
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02476253
Brief Title
Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill
Acronym
(BICAR-ICU)
Official Title
Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill : A Multiple Center Randomized Clinical Trial (BICAR-ICU)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 5, 2015 (Actual)
Primary Completion Date
September 15, 2017 (Anticipated)
Study Completion Date
October 13, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Acidosis
Keywords
acidosis, shock, sodium bicarbonate, renal replacement therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
Sodium Bicarbonate
Intervention Description
Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30
Primary Outcome Measure Information:
Title
Composite criteria of Day 28 mortality and/or patients with at least one organ failure defined as a SOFA score of 3 or 4
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
Time Frame
Day 0 to Day 28
Secondary Outcome Measure Information:
Title
Evolution of the organ failure scores
Description
use of SOFA score to assess the outcome 2
Time Frame
Day 0 to Day 28
Title
Duration of renal replacement therapy (days)
Description
need to renal replacement therapy
Time Frame
Day 0 to Day 28
Title
Duration of mechanical ventilation and ventilatory free days (days)
Description
duration of mechanical ventilation and ventilatory free days
Time Frame
Day 0 to Day 28
Title
Duration of vasopressors administration (h)
Description
need for vasopressors and fluids using duration of vasopressor infusion (D0 to D28)
Time Frame
Day 0 to Day 28
Title
Hospital acquired infections (incidence)
Description
hospital acquired infections using United States Centers for Disease Control definitions and a dedicated document
Time Frame
Day 0 to Day 28
Title
Amount of intravenous fluid (ml)
Time Frame
Day 0 to Day 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boris JUNG, MD
Phone
0467337271
Email
b-jung@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Samir Jaber, MD
Phone
0467337271
Email
s-jaber@chu-montpellier.fr
Facility Information:
Facility Name
DAR St Eloi
City
Montpellier
ZIP/Postal Code
34000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samir Jaber, MD, PhD
Phone
33467337271
Email
s-jaber@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Boris Jung, MD, PhD
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Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill
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