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Sodium Bicarbonate for Critically Ill Patients With Metabolic Acidosis and Acute Kidney Injury

NCT07464431 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2026-05-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Balanced crystalloid solution

Intravenous 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.

DRUG

Sodium Bicarbonate 8.4% Solution for Injection

Intravenous 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.

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER

  • Universität Münster

    lead OTHER

Principal Investigators

  • Alexander Zarbock, MD · University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Medicine and Pain Therapy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-06-30
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07464431 on ClinicalTrials.gov