Evaluating the clinical effectiveness of sodium bicarbonate for critically ill patients with metabolic acidosis and acute kidney injury

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaet Muenster

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

30 Apr 2026 → ongoing

Decision date (initial)

2026-03-17

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

German Research Foundation (Deutsche Forschungsgemeinschaft, DFG)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To investigate the effect of sodium bicarbonate on major adverse kidney events at day 90

Secondary objectives 4

1. To investigate the effect of sodium bicarbonate on 90-day all-cause mortality
2. To investigate the effect of sodium bicarbonate on persistent renal dysfunction
3. To investigate the effect of sodium bicarbonate on KRT requirement during the first 90 days after randomization and KRT dependence at day 90
4. To investigate the effect of sodium bicarbonate on KRT-free days up to day 90

Conditions and MedDRA coding

Critical illness

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Adult ≥ 18 years
2. Critically ill patients (requiring treatment on an Intensive Care Unit or Intermediate Care Unit)
3. Metabolic acidosis, defined as all of the following: a. Arterial pH ≤7.25 b. PaCO2 < 6.5kPa (<49 mmHg) c. Standard bicarbonate ≤20 mmol/L d. Standard Base Excess <-2
4. AKI stage 2 or 3 of the KDIGO classification
5. Written informed consent of the patient or legal representative or authorized representative or emergency inclusion (according to Article 35 EU-Regulation 536/2014)

Exclusion criteria 12

1. Respiratory acidosis (acute or chronic)
2. Patients on KRT, or KRT immediately indicated and treating clinician(s) unwilling to defer
3. Deemed unsuitable for KRT
4. High output stoma/ileostomy
5. Percutaneous biliary drainage
6. End stage kidney failure defined as documented eGFR <15ml/min/1.73m2 prior to onset of this acute illness or end stage kidney disease (ESKD) on dialysi
7. Known renal tubular acidosis
8. Diabetic ketoacidosis
9. High anion gap acid poisoning (e.g. polyethylene glycol (PEG), aspirin, methanol)
10. Symptomatic hypocalcaemia (Ionized calcium <1.05 mmol/L)
11. Hypernatremia (plasma sodium >150 mmol/L)
12. Severe hypokalemia (potassium <3.0 mmol/L)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Major adverse kidney events (MAKE90) Binary endpoint consisting of mortality or any KRT within 90 days after randomization or persistent renal dysfunction (creatinine value at day 90 ≥200% of baseline value) at day 90

Secondary endpoints 5

1. 90-day all-cause mortality (%)
2. Elevation of the creatinine level to ≥200% of baseline value at day 90 (one measurement between day 80 and 120 after randomization)
3. Receipt of any form of KRT within the 90-day time period after randomization
4. Kidney Replacement Therapy (KRT)-dependence at day 90 after randomization
5. KRT-free days, defined as difference between number of days alive and number of days receiving KRT of any form between randomization and day 90

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaet Muenster

Sponsor organisation

Universitaet Muenster

Address

Schlossplatz 2, Schlossbezirk Schlossbezirk

City

Muenster

Postcode

48149

Country

Germany

Scientific contact point

Organisation

Universitaet Muenster

Contact name

Principal Coordinating Investigator

Public contact point

Organisation

Universitaet Muenster

Contact name

Principal Coordinating Investigator

Locations

1 EU/EEA country · 23 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications