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Can baking soda save kidneys? new trial tests cheap treatment for ICU patients

NCT ID NCT07464431

Disease control Sponsor: Universität Münster Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests whether giving sodium bicarbonate (baking soda) intravenously can reduce major kidney problems or death in critically ill patients with metabolic acidosis and acute kidney injury. About 660 adults in intensive care will receive either sodium bicarbonate or a standard balanced fluid. The main goal is to see if fewer patients die, need dialysis, or have lasting kidney damage within 90 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sodium bicarbonate
What this could lead to
If it works, this could provide a simple, low-cost treatment to reduce the risk of kidney failure or death in critically ill patients with acute kidney injury.
What could go wrong
This is a phase 4 trial, but previous evidence is limited to a subgroup analysis. The treatment may not show benefit, and sodium bicarbonate can cause side effects like fluid overload or electrolyte imbalances.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 660 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult ≥ 18 years 2. Critically ill patients (requiring treatment on an ICU or IMC) 3. Metabolic acidosis, defined as all of the following: 1. Arterial pH ≤7.25 2. PaCO2 \< 6.5kPa (\<49 mmHg) 3. Standard bicarbonate ≤20 mmol/L 4. 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: 1. Pregnant or breastfeeding patients 2. Respiratory acidosis (acute or chronic) \[dynamic, and if corrected, patient may be reconsidered for the trial\] 3. Patients on KRT, or KRT immediately indicated and treating clinician(s) unwilling to defer 4. Deemed unsuitable for KRT 5. High output stoma/ileostomy 6. Percutaneous biliary drainage 7. 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 8. Known renal tubular acidosis 9. Diabetic ketoacidosis 10. High anion gap acid poisoning (e.g. polyethylene glycol (PEG), aspirin, methanol) 11. Symptomatic hypocalcaemia (Ionized calcium \<1.05 mmol/L)\[dynamic, and if corrected, patient may be reconsidered for the trial\] 12. Hypernatremia (plasma sodium \>150 mmol/L)\[dynamic, and if corrected, patient may be reconsidered for the trial\] 13. Severe hypokalemia (potassium \<3.0 mmol/L)\[dynamic, and if corrected, patient may be reconsidered for the trial\] 14. Death perceived as imminent 15. Known hypersensitivity to sodium bicarbonate or EDTA (Disodiumedetate) 16. Previously randomized into ESCALATE

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Conditions

The condition(s) this trial relates to.

Acidosis acute kidney injury Critical Illness metabolic acidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute kidney injury Critical illness Metabolic acidosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Münster, University Hospital Münster

    RECRUITING

    Münster, 48149, Germany

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