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Completed

NCT Number: NCT02476253

Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill

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.

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Key information

Conditions

Metabolic Acidosis Acid-Base Imbalance Acidosis Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

DAR St Eloi

Montpellier, 34000, France

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sodium bicarbonate

Drug

Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: (BICAR-ICU)

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 19, 2015
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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