Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill
NCT ID: NCT02476253
Last Updated: 2024-05-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
400 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-05-05
Study Completion Date
2017-05-29
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.
The study is a randomized multiple center clinical trial with the outcome as a primary endpoint.
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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
* 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
Conditions
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Metabolic Acidosis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Intervention
Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30
Group Type
EXPERIMENTAL
Sodium Bicarbonate
Intervention Type
DRUG
Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30
Control
No intervention
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Sodium Bicarbonate
Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30
Intervention Type
DRUG
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
* 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)
* 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)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University Hospital, Montpellier
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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DAR St Eloi
Montpellier, , France
Site Status
Countries
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France
References
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Jaber S, Paugam C, Futier E, Lefrant JY, Lasocki S, Lescot T, Pottecher J, Demoule A, Ferrandiere M, Asehnoune K, Dellamonica J, Velly L, Abback PS, de Jong A, Brunot V, Belafia F, Roquilly A, Chanques G, Muller L, Constantin JM, Bertet H, Klouche K, Molinari N, Jung B; BICAR-ICU Study Group. Sodium bicarbonate therapy for patients with severe metabolic acidaemia in the intensive care unit (BICAR-ICU): a multicentre, open-label, randomised controlled, phase 3 trial. Lancet. 2018 Jul 7;392(10141):31-40. doi: 10.1016/S0140-6736(18)31080-8. Epub 2018 Jun 14.
Reference Type
DERIVED
Other Identifiers
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9260
Identifier Type: -
Identifier Source: org_study_id
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