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Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill ((BICAR-ICU))

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ClinicalTrials.gov Identifier: NCT02476253
Recruitment Status : Recruiting
First Posted : June 19, 2015
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease Intervention/treatment Phase
Metabolic Acidosis Drug: Sodium Bicarbonate Phase 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill : A Multiple Center Randomized Clinical Trial (BICAR-ICU)
Actual Study Start Date : May 5, 2015
Estimated Primary Completion Date : September 15, 2017
Estimated Study Completion Date : October 13, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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
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: Control
No intervention



Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Evolution of the organ failure scores [ Time Frame: Day 0 to Day 28 ]
    use of SOFA score to assess the outcome 2

  2. Duration of renal replacement therapy (days) [ Time Frame: Day 0 to Day 28 ]
    need to renal replacement therapy

  3. Duration of mechanical ventilation and ventilatory free days (days) [ Time Frame: Day 0 to Day 28 ]
    duration of mechanical ventilation and ventilatory free days

  4. Duration of vasopressors administration (h) [ Time Frame: Day 0 to Day 28 ]
    need for vasopressors and fluids using duration of vasopressor infusion (D0 to D28)

  5. Hospital acquired infections (incidence) [ Time Frame: Day 0 to Day 28 ]
    hospital acquired infections using United States Centers for Disease Control definitions and a dedicated document

  6. Amount of intravenous fluid (ml) [ Time Frame: Day 0 to Day 2 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476253


Contacts
Contact: Boris JUNG, MD 0467337271 b-jung@chu-montpellier.fr
Contact: Samir Jaber, MD 0467337271 s-jaber@chu-montpellier.fr

Locations
France
DAR St Eloi Recruiting
Montpellier, France, 34000
Contact: Samir Jaber, MD, PhD    33467337271    s-jaber@chu-montpellier.fr   
Principal Investigator: Boris Jung, MD, PhD         
Sponsors and Collaborators
University Hospital, Montpellier

Publications:
Ichai C, Massa H, Hubert S. c. In: SAS EM, editor. EMC Anesthésie-Réanimation. Paris; 2006.
Correction de l'acidose métabolique en réanimation. 1999 [cited; Available from: http://www.urgences-serveur.fr/IMG/pdf/correction_acidose.pdf

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02476253     History of Changes
Other Study ID Numbers: 9260
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: March 2017

Keywords provided by University Hospital, Montpellier:
acidosis
shock
sodium bicarbonate
renal replacement therapy

Additional relevant MeSH terms:
Critical Illness
Acidosis
Disease Attributes
Pathologic Processes
Acid-Base Imbalance
Metabolic Diseases