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

NCT07464431 | Not Yet Recruiting Phase 4 DMC

• 3 other identifiers: UniMS23_00175381172532025-523914-10-00
• Study Type: interventional
• Target: 660
• Locations: 0 countries
• Sites: N/A

Brief 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

Acute Kidney Injury; Metabolic Acidosis; Critical Illness

Keywords

Acute kidney injury; Metabolic acidosis; Critical illness; Sodium bicarbonate

Outcome Measures

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)

  90 days after randomization

Secondary Outcomes (5)

• 90-day all-cause mortality (%)

  90 days after randomization

• Elevation of the creatinine level to ≥200% of base value at day 90 (one measurement between day 80 and 120 after randomization)

  80 - 120 days after randomization

• Receipt of any form of KRT within the 90-day time period after randomization

  90 days after randomization

• KRT-dependence on day 90

  90 days after randomization

• KRT-free days, defined as difference between number of days receiving KRT of any form between randomization and day 90 and number of days alive

  90 days after randomization

Other Outcomes (10)

• ICU-Mortality (%)

  90 days after randomization

• Hospital Mortality (%)

  90 days after randomization

• Incidence of suspected unexpected serious adverse reactions (SUSARs)

  from randomization until the end of treatment phase (up to day 7 OR Discharge from the intensive care unit, whatever comes first

Study Arms (2)

Sodium Bicarbonate

EXPERIMENTAL

Experimental: Sodium Bicarbonate 8.4% w/v Intravenous infusion according to the treatment algorithm targeting a pH\>7.30

Drug: Sodium Bicarbonate 8.4% Solution for Injection

Balanced crystalloid solution

PLACEBO COMPARATOR

Placebo: Balanced crystalloid solution Intravenous infusion according to the treatment algorithm targeting a pH\>7.30

Drug: Balanced crystalloid solution

Interventions

Balanced crystalloid solution DRUG

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.

Balanced crystalloid solution

Sodium Bicarbonate 8.4% Solution for Injection DRUG

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.

Sodium Bicarbonate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• High output stoma/ileostomy
• Percutaneous biliary drainage
• End stage kidney failure defined as documented eGFR \<15ml/min/1.73m 2 prior to onset of this acute illness or end stage kidney disease (ESKD) on dialysis
• Known renal tubular acidosis
• Diabetic ketoacidosis
• High anion gap acid poisoning (e.g. polyethylene glycol (PEG), aspirin, methanol)
• Symptomatic hypocalcaemia (Ionized calcium \<1.05 mmol/L)\[dynamic, and if corrected, patient may be reconsidered for the trial\]
• Hypernatremia (plasma sodium \>150 mmol/L)\[dynamic, and if corrected, patient may be reconsidered for the trial\]
• Severe hypokalemia (potassium \<3.0 mmol/L)\[dynamic, and if corrected, patient may be reconsidered for the trial\]
• Death perceived as imminent
• Known hypersensitivity to sodium bicarbonate or EDTA (Disodiumedetate)

Sponsors & Collaborators

• Universität Münster: lead
• German Research Foundation: collaborator

MeSH Terms

Conditions

Acute Kidney Injury; Acidosis; Critical Illness

Interventions

Sodium Bicarbonate; Solutions; Injections

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Alexander Zarbock, MD

  University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Medicine and Pain Therapy

  STUDY CHAIR

Central Study Contacts

Alexander Zarbock, MD

CONTACT

+49251-8347255; ESCALATE@ukmuenster.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: March 11, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: With whom? Researchers who provide a methodologically sound proposal By what mechanism will data be made available? Proposals should be directed to ESCALATE@ukmuenster.de. To gain access, data requestors will need to sign a data access agreement.