Metabolic AcidosisPhase 3(BICAR-ICU)NCT02476253
Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill
A Phase 3 study testing Sodium Bicarbonate in people with Metabolic Acidosis, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Acidosis
- What is being tested?
- Sodium Bicarbonate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2015to 29 May 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Metabolic Acidosis
- Being tested
- Sodium Bicarbonate
- Keywords
- acidosis, shock, sodium bicarbonate, renal replacement therapy
- Medical subject headings
- Acidosis, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium BicarbonateDrug
Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30 Receives: Drug: Sodium Bicarbonate |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0 to Day 28
Secondary outcomes (6)
Evolution of the organ failure scores
use of SOFA score to assess the outcome 2
Measured: Day 0 to Day 28
Duration of renal replacement therapy (days)
need to renal replacement therapy
Measured: Day 0 to Day 28
Duration of mechanical ventilation and ventilatory free days (days)
duration of mechanical ventilation and ventilatory free days
Measured: Day 0 to Day 28
Duration of vasopressors administration (h)
need for vasopressors and fluids using duration of vasopressor infusion (D0 to D28)
Measured: Day 0 to Day 28
Hospital acquired infections (incidence)
hospital acquired infections using United States Centers for Disease Control definitions and a dedicated document
Measured: Day 0 to Day 28
Amount of intravenous fluid (ml)
Measured: Day 0 to Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study start5 May 2015
- Primary completion29 May 2017
- Study completion29 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Metabolic AcidosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476253
- Sponsor's protocol ID
- 9260
- Acronym
- (BICAR-ICU)
- Status last verified
- May 2026
- First submitted
- 10 Jun 2015
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kellum JA, Levin N, Bouman C, Lameire N. Developing a consensus classification system for acute renal failure. Curr Opin Crit Care. 2002 Dec;8(6):509-14. doi: 10.1097/00075198-200212000-00005.
PubMed 12454534Dubin A, Menises MM, Masevicius FD, Moseinco MC, Kutscherauer DO, Ventrice E, Laffaire E, Estenssoro E. Comparison of three different methods of evaluation of metabolic acid-base disorders. Crit Care Med. 2007 May;35(5):1264-70. doi: 10.1097/01.CCM.0000259536.11943.90.
PubMed 17334252Smith I, Kumar P, Molloy S, Rhodes A, Newman PJ, Grounds RM, Bennett ED. Base excess and lactate as prognostic indicators for patients admitted to intensive care. Intensive Care Med. 2001 Jan;27(1):74-83. doi: 10.1007/s001340051352.
PubMed 11280677Gunnerson KJ, Saul M, He S, Kellum JA. Lactate versus non-lactate metabolic acidosis: a retrospective outcome evaluation of critically ill patients. Crit Care. 2006 Feb;10(1):R22. doi: 10.1186/cc3987.
PubMed 16507145Jung B, Rimmele T, Le Goff C, Chanques G, Corne P, Jonquet O, Muller L, Lefrant JY, Guervilly C, Papazian L, Allaouchiche B, Jaber S; AzuRea Group. Severe metabolic or mixed acidemia on intensive care unit admission: incidence, prognosis and administration of buffer therapy. A prospective, multiple-center study. Crit Care. 2011;15(5):R238. doi: 10.1186/cc10487. Epub 2011 Oct 13.
PubMed 21995879Husain FA, Martin MJ, Mullenix PS, Steele SR, Elliott DC. Serum lactate and base deficit as predictors of mortality and morbidity. Am J Surg. 2003 May;185(5):485-91. doi: 10.1016/s0002-9610(03)00044-8.
PubMed 12727572Kellum JA. Clinical review: reunification of acid-base physiology. Crit Care. 2005 Oct 5;9(5):500-7. doi: 10.1186/cc3789. Epub 2005 Aug 5.
PubMed 16277739Forsythe SM, Schmidt GA. Sodium bicarbonate for the treatment of lactic acidosis. Chest. 2000 Jan;117(1):260-7. doi: 10.1378/chest.117.1.260.
PubMed 10631227Fencl V, Jabor A, Kazda A, Figge J. Diagnosis of metabolic acid-base disturbances in critically ill patients. Am J Respir Crit Care Med. 2000 Dec;162(6):2246-51. doi: 10.1164/ajrccm.162.6.9904099.
PubMed 11112147Kellum JA, Song M, Almasri E. Hyperchloremic acidosis increases circulating inflammatory molecules in experimental sepsis. Chest. 2006 Oct;130(4):962-7. doi: 10.1378/chest.130.4.962.
PubMed 17035425Kellum JA, Song M, Venkataraman R. Effects of hyperchloremic acidosis on arterial pressure and circulating inflammatory molecules in experimental sepsis. Chest. 2004 Jan;125(1):243-8. doi: 10.1378/chest.125.1.243.
PubMed 14718447Morimoto Y, Morimoto Y, Kemmotsu O, Alojado ES. Extracellular acidosis delays cell death against glucose-oxygen deprivation in neuroblastoma x glioma hybrid cells. Crit Care Med. 1997 May;25(5):841-7. doi: 10.1097/00003246-199705000-00021.
PubMed 9187605Laffey JG, O'Croinin D, McLoughlin P, Kavanagh BP. Permissive hypercapnia--role in protective lung ventilatory strategies. Intensive Care Med. 2004 Mar;30(3):347-56. doi: 10.1007/s00134-003-2051-1. Epub 2004 Jan 14.
PubMed 14722644Kraut JA, Madias NE. Metabolic acidosis: pathophysiology, diagnosis and management. Nat Rev Nephrol. 2010 May;6(5):274-85. doi: 10.1038/nrneph.2010.33. Epub 2010 Mar 23.
PubMed 20308999Cohen MV, Yang XM, Downey JM. The pH hypothesis of postconditioning: staccato reperfusion reintroduces oxygen and perpetuates myocardial acidosis. Circulation. 2007 Apr 10;115(14):1895-903. doi: 10.1161/CIRCULATIONAHA.106.675710. Epub 2007 Mar 26.
PubMed 17389262
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill : A Multiple Center Randomized Clinical Trial (BICAR-ICU)
- ClinicalTrials.gov ID
- NCT02476253
- Acronym / sponsor ID
- (BICAR-ICU) / 9260
- Conditions
- Metabolic Acidosis
- Keywords
- acidosis, shock, sodium bicarbonate, renal replacement therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 5 May 2015 (actual)
- Primary completion
- 29 May 2017 (actual)
- Study completion
- 29 May 2017 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Sodium BicarbonateIntravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30 |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium BicarbonateIntravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30 | Drug | Intervention |
Primary outcome
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
6 secondary outcomes
Evolution of the organ failure scores
Time frame: Day 0 to Day 28
Duration of renal replacement therapy (days)
Time frame: Day 0 to Day 28
Duration of mechanical ventilation and ventilatory free days (days)
Time frame: Day 0 to Day 28
Duration of vasopressors administration (h)
Time frame: Day 0 to Day 28
Hospital acquired infections (incidence)
Time frame: Day 0 to Day 28
Amount of intravenous fluid (ml)
Time frame: Day 0 to Day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Background: PubMed 12454534Kellum JA, Levin N, Bouman C, Lameire N. Developing a consensus classification system for acute renal failure. Curr Opin Crit Care. 2002 Dec;8(6):509-14. doi: 10.1097/00075198-200212000-00005.
- Background: PubMed 17334252Dubin A, Menises MM, Masevicius FD, Moseinco MC, Kutscherauer DO, Ventrice E, Laffaire E, Estenssoro E. Comparison of three different methods of evaluation of metabolic acid-base disorders. Crit Care Med. 2007 May;35(5):1264-70. doi: 10.1097/01.CCM.0000259536.11943.90.
- Background: PubMed 11280677Smith I, Kumar P, Molloy S, Rhodes A, Newman PJ, Grounds RM, Bennett ED. Base excess and lactate as prognostic indicators for patients admitted to intensive care. Intensive Care Med. 2001 Jan;27(1):74-83. doi: 10.1007/s001340051352.
- Background: PubMed 16507145Gunnerson KJ, Saul M, He S, Kellum JA. Lactate versus non-lactate metabolic acidosis: a retrospective outcome evaluation of critically ill patients. Crit Care. 2006 Feb;10(1):R22. doi: 10.1186/cc3987.
- Background: PubMed 21995879Jung B, Rimmele T, Le Goff C, Chanques G, Corne P, Jonquet O, Muller L, Lefrant JY, Guervilly C, Papazian L, Allaouchiche B, Jaber S; AzuRea Group. Severe metabolic or mixed acidemia on intensive care unit admission: incidence, prognosis and administration of buffer therapy. A prospective, multiple-center study. Crit Care. 2011;15(5):R238. doi: 10.1186/cc10487. Epub 2011 Oct 13.
- Background: PubMed 12727572Husain FA, Martin MJ, Mullenix PS, Steele SR, Elliott DC. Serum lactate and base deficit as predictors of mortality and morbidity. Am J Surg. 2003 May;185(5):485-91. doi: 10.1016/s0002-9610(03)00044-8.
- Background: PubMed 16277739Kellum JA. Clinical review: reunification of acid-base physiology. Crit Care. 2005 Oct 5;9(5):500-7. doi: 10.1186/cc3789. Epub 2005 Aug 5.
- Background: PubMed 10631227Forsythe SM, Schmidt GA. Sodium bicarbonate for the treatment of lactic acidosis. Chest. 2000 Jan;117(1):260-7. doi: 10.1378/chest.117.1.260.
- Background: PubMed 11112147Fencl V, Jabor A, Kazda A, Figge J. Diagnosis of metabolic acid-base disturbances in critically ill patients. Am J Respir Crit Care Med. 2000 Dec;162(6):2246-51. doi: 10.1164/ajrccm.162.6.9904099.
- Background: PubMed 17035425Kellum JA, Song M, Almasri E. Hyperchloremic acidosis increases circulating inflammatory molecules in experimental sepsis. Chest. 2006 Oct;130(4):962-7. doi: 10.1378/chest.130.4.962.
- Background: PubMed 14718447Kellum JA, Song M, Venkataraman R. Effects of hyperchloremic acidosis on arterial pressure and circulating inflammatory molecules in experimental sepsis. Chest. 2004 Jan;125(1):243-8. doi: 10.1378/chest.125.1.243.
- Background: PubMed 9187605Morimoto Y, Morimoto Y, Kemmotsu O, Alojado ES. Extracellular acidosis delays cell death against glucose-oxygen deprivation in neuroblastoma x glioma hybrid cells. Crit Care Med. 1997 May;25(5):841-7. doi: 10.1097/00003246-199705000-00021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium Bicarbonate in people with Metabolic Acidosis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02476253, which also lists 39 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.