Sodium Bicarbonate for Critically Ill Patients With Metabolic Acidosis and Acute Kidney Injury
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversität Münster
About this trial
The study investigates whether sodium bicarbonate is able to reduce the occurrence of major adverse kidney events on day 90 (MAKE90) in critically ill patients with metabolic acidosis and acute kidney injury (AKI). While its efficacy in this context has been suggested in a subgroup analysis of the BICAR-ICU trial it has not been confirmed in a double-blinded randomized controlled trial to date.
Eligibility criteria
Qualifiers
Adult ≥ 18 years
Critically ill patients (requiring treatment on an ICU or IMC)
Arterial pH ≤7.25
PaCO2 < 6.5kPa (<49 mmHg)
Disqualifiers
Pregnant or breastfeeding patients
Respiratory acidosis (acute or chronic) [dynamic, and if corrected, patient may be reconsidered for the trial]
Patients on KRT, or KRT immediately indicated and treating clinician(s) unwilling to defer
Deemed unsuitable for KRT
Trial design
Treatments tested in this trial
- Sodium Bicarbonate 8.4% Solution for Injection
- Balanced crystalloid solution
Treatment groups
660 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Universität Münster
Lead sponsor
German Research Foundation
Collaborator
Source ClinicalTrials.gov