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

April 20, 2017 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Montpellier, France, 34000
        • Recruiting
        • DAR St Eloi
        • Contact:
        • Principal Investigator:
          • Boris Jung, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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
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
Day 0 to Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of the organ failure scores
Time Frame: Day 0 to Day 28
use of SOFA score to assess the outcome 2
Day 0 to Day 28
Duration of renal replacement therapy (days)
Time Frame: Day 0 to Day 28
need to renal replacement therapy
Day 0 to Day 28
Duration of mechanical ventilation and ventilatory free days (days)
Time Frame: Day 0 to Day 28
duration of mechanical ventilation and ventilatory free days
Day 0 to Day 28
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)
Day 0 to Day 28
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
Day 0 to Day 28
Amount of intravenous fluid (ml)
Time Frame: Day 0 to Day 2
Day 0 to Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2015

Primary Completion (Anticipated)

September 15, 2017

Study Completion (Anticipated)

October 13, 2017

Study Registration Dates

First Submitted

June 10, 2015

First Submitted That Met QC Criteria

June 18, 2015

First Posted (Estimate)

June 19, 2015

Study Record Updates

Last Update Posted (Actual)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 20, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9260

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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