Metabolic Acidosis Clinical Trials

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Evaluating the Clinical Effectiveness of Sodium Bicarbonate for Critically Ill Patients With Metabolic Acidosis and Acute Kidney Injury (ESCALATE)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult ≥ 18 years

• Critically ill patients (requiring treatment on an ICU or IMC)

• Metabolic acidosis, defined as all of the following:

‣ Arterial pH ≤7.25

⁃ PaCO2 \< 6.5kPa (\<49 mmHg)

⁃ Standard bicarbonate ≤20 mmol/L

⁃ Standard Base Excess \<-2

• AKI stage 2 or 3 of the KDIGO classification

• Written informed consent of the patient or legal representative or authorized representative or emergency inclusion (according to Article 35 EU-Regulation 536/2014)

Locations
Other Locations
Germany
University Münster, University Hospital Münster
RECRUITING
Münster
Contact Information
Primary
Alexander Zarbock, MD
ESCALATE@ukmuenster.de
+49251-8347255
Time Frame
Start Date: 2026-05-07
Estimated Completion Date: 2028-12
Participants
Target number of participants: 660
Treatments
Experimental: Sodium Bicarbonate
Experimental: Sodium Bicarbonate 8.4% w/v Intravenous infusion according to the treatment algorithm targeting a pH\>7.30
Placebo_comparator: Balanced crystalloid solution
Placebo: Balanced crystalloid solution Intravenous infusion according to the treatment algorithm targeting a pH\>7.30
Related Therapeutic Areas
Sponsors
Collaborators: German Research Foundation
Leads: Universität Münster

This content was sourced from clinicaltrials.gov