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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02476253 |
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Date of registration:
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10/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill
(BICAR-ICU) |
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Scientific title:
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Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill : A Multiple Center Randomized Clinical Trial (BICAR-ICU) |
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Date of first enrolment:
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May 5, 2015 |
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Target sample size:
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400 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02476253 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Boris JUNG, MD |
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Address:
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Telephone:
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0467337271 |
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Email:
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b-jung@chu-montpellier.fr |
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Affiliation:
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Name:
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Samir Jaber, MD, PhD |
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Address:
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Telephone:
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33467337271 |
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Email:
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s-jaber@chu-montpellier.fr |
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Affiliation:
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Key inclusion & exclusion 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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Metabolic Acidosis
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Intervention(s)
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Drug: Sodium Bicarbonate
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Duration of mechanical ventilation and ventilatory free days (days)
[Time Frame: Day 0 to Day 28]
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Evolution of the organ failure scores
[Time Frame: Day 0 to Day 28]
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Hospital acquired infections (incidence)
[Time Frame: Day 0 to Day 28]
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Amount of intravenous fluid (ml)
[Time Frame: Day 0 to Day 2]
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Duration of renal replacement therapy (days)
[Time Frame: Day 0 to Day 28]
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Duration of vasopressors administration (h)
[Time Frame: Day 0 to Day 28]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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