Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill

Metabolic Acidosis Clinical Trial

— (BICAR-ICU)  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02476253
• Other study ID #: 9260
• Status: Recruiting
• Phase: Phase 3
• First received: June 10, 2015
• Last updated: April 20, 2017
• Start date: May 5, 2015
• Est. completion date: October 13, 2017

Study information

• Verified date: March 2017
• Source: University Hospital, Montpellier
• Contact: Boris JUNG, MD
• Phone: 0467337271
• Email: b-jung[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 13, 2017
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acidosis
• Critical Illness
• Metabolic Acidosis

Intervention

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

Locations

Country	Name	City	State
France	DAR St Eloi	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (38)

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 0 to Day 28
Secondary	Evolution of the organ failure scores	use of SOFA score to assess the outcome 2	Day 0 to Day 28
Secondary	Duration of renal replacement therapy (days)	need to renal replacement therapy	Day 0 to Day 28
Secondary	Duration of mechanical ventilation and ventilatory free days (days)	duration of mechanical ventilation and ventilatory free days	Day 0 to Day 28
Secondary	Duration of vasopressors administration (h)	need for vasopressors and fluids using duration of vasopressor infusion (D0 to D28)	Day 0 to Day 28
Secondary	Hospital acquired infections (incidence)	hospital acquired infections using United States Centers for Disease Control definitions and a dedicated document	Day 0 to Day 28
Secondary	Amount of intravenous fluid (ml)		Day 0 to Day 2