Baking soda treatment tested for ICU kidney patients
NCT ID NCT04010630
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether giving sodium bicarbonate (a common substance that neutralizes acid) to critically ill patients with severe metabolic acidosis and moderate-to-severe acute kidney injury could improve survival at 90 days. The trial enrolled 640 adults in the ICU who had very acidic blood and kidney problems. The goal was to see if this simple treatment could reduce the high death rate (around 55-60%) seen in these patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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640 people
The number who actually took part.
- Started
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Oct 2019
- Finished
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Jun 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged from 18 years old * Admitted in the ICU where the BICARICU-2 trial takes place * Within 6h before enrolment, the patient MUST present on the same arterial blood gas (the last available before enrollment) the 3 following criteria: pH ≤ 7.20 ; Bicarbonatemia ≤ 20 mmol/l ; AND PaCO2 ≤ 45mmHg ; * Moderate to severe acute kidney injury ("Kidney Disease Improving Global Outcome", KDIGO group of 2 or 3) * Within 48h of ICU admission, a total SOFA ≥ 4 OR an arterial lactate concentration ≥ 2 mmol/l * Signed informed consent form. According to the French law, considering the severity of the illness, the fact that most of these patients would be unable to consent (sedation or potential delirium) and that their proxies might not be contactable at the time of inclusion, a deferred consent process for emergency situations will be enabled. When deferred consent will be used, written permission to pursue the research will be obtained from the patient or proxy as soon as possible. If this consent is not obtained, the patient's data will not be used and they will be withdrawn from the trial. * Subjects must be covered by public health insurance Exclusion Criteria: * Pure respiratory acidosis (defined by pH 7.20, PaCO2 \>50 mmHg, bicarbonatemia equal or greater than (PaCO2-40)/10 + 24), digestive or urinary tract proven loss of fluid (equal or greater than 1500ml/24h) with concomitant loss of sodium bicarbonate, chronic kidney insufficiency (creatinine clearance ≤ 10ml/min), proven tubular acidosis, ketoacidosis, exogenous acids poisoning (aspirin, methanol, ), PaCO2 \> 45 mmHg and spontaneous breathing, sodium bicarbonate infusion or renal replacement therapy within 24h prior to screening prior to screening or imminent in the next 6h. * Pregnant or breast feeding patient * Patient who is in a dependency or employment with the sponsor or the investigator * Patient who was enrolled in another study and who is in the exclusion period for any enrolment in the present study * Life expectancy less than 48h * Consent refusal from the patient or his/her next of kin and the impossibility to enrol using the emergency procedure * Patients protected by law (Art.L 1121-5, 1121-6, 1121-8 du Code de la santé publique) * Absence of a French Health Care Insurance coverage
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Service de médecine intensive et réanimation
Montpellier, 34000, France
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