Sodium Bicarbonate for Critically Ill Patients With Metabolic Acidosis and Acute Kidney Injury
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Sodium Bicarbonate 8.4% Solution for Injection
DrugIntravenous infusion according to the treatment algorithm. Infusion starts with 100ml/hr until a pH of 7.30 - 7.35 and a Base Excess of ≥ 0 is reached. Then, infusion is reduced to 25ml/hr and maintained for 5 hours. After 5 hours, infusion is titrated to a pH of \>7.30.
Balanced crystalloid solution
DrugIntravenous infusion according to the treatment algorithm. Infusion starts with 100ml/hr until a pH of 7.30 - 7.35 and a Base Excess of ≥ 0 is reached. Then, infusion is reduced to 25ml/hr and maintained for 5 hours. After 5 hours, infusion is titrated to a pH of \>7.30.
Treatment groups
660 Participants
are divided into 2 treatment groupsGroup A: Sodium BicarbonateExperimental treatment 1 intervention
Group B: Balanced crystalloid solutionPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
MAKE90 (consisting of mortality, dialysis within 90 days, persistent renal dysfunction (defined as serum creatinine ≥ 2x compared to baseline value at day 90)
Time frame
90 days after randomizationSecondary outcomes
1
90-day all-cause mortality (%)
Time frame
90 days after randomization2
Elevation of the creatinine level to ≥200% of base value at day 90 (one measurement between day 80 and 120 after randomization)
Time frame
80 - 120 days after randomization3
Receipt of any form of KRT within the 90-day time period after randomization
Time frame
90 days after randomization4
KRT-dependence on day 90
Time frame
90 days after randomizationOther outcomes
1
ICU-Mortality (%)
Time frame
90 days after randomization2
Hospital Mortality (%)
Time frame
90 days after randomization3
Incidence of suspected unexpected serious adverse reactions (SUSARs)
Time frame
from randomization until the end of treatment phase (up to day 7 OR Discharge from the intensive care unit, whatever comes first4
KRT-free days up to day 28
Time frame
28 days after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universität Münster
Lead sponsor
German Research Foundation
Collaborator
Source ClinicalTrials.gov