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Can baking soda save kidneys in the ICU? new trial aims to find out

NCT ID NCT05697770

Disease control Sponsor: Australian and New Zealand Intensive Care Research Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving sodium bicarbonate (baking soda) to adults in the intensive care unit with metabolic acidosis can reduce the risk of major kidney problems or death within 30 days. The trial involves 500 participants who will receive either sodium bicarbonate or a placebo (sugar water) through an IV for up to 5 hours. Researchers will track outcomes like death, need for dialysis, and persistent kidney damage.

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 prevent kidney failure or death in critically ill patients with metabolic acidosis.
What could go wrong
This is a phase 3 trial, but previous studies on sodium bicarbonate for acidosis have shown mixed results. The benefit may be small or absent, and the infusion itself carries risks like fluid overload.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

500 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Jul 2026

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: All the diagnostic criteria of metabolic acidosis below have to be fulfilled within the last 2 hours before randomisation (pH, PaCO2 and BE from the same blood gas), and a vasopressor is being infused continuously at the time of randomization. 1. Adults (≥ 18 years); 2. Receiving a continuous infusion of a vasopressor to maintain mean arterial pressure \> 65 mmHg (or a mean arterial pressure target set by the treating clinician); 3. A dedicated intravenous line (central or peripheral) is available (or insertion of such a line is planned within the next hour); and 4. Metabolic acidosis, defined as: 1. pH \< 7.30; and 2. BE ≤ -4 mEq/L; and 3. PaCO2 ≤ 45 mmHg for non-intubated patients or PaCO2 ≤ 50 mmHg for intubated patients. Exclusion Criteria: 1. Fulfilled all eligibility criteria greater than 48 hours ago; or 2. Suspected clinically significant digestive or urinary tract loss of sodium bicarbonate (e.g., diarrhoea, ileostomy losses, renal tubular acidosis, or drainage of pancreatic or bile duct); or 3. DKA; or 4. Estimated glomerular filtration rate (eGFR) \< 30 mL/min due to chronic kidney disease; or 5. Currently receiving sodium bicarbonate at the moment of randomisation (doses of sodium bicarbonate prior to randomisation are allowed); or 6. Currently receiving RRT (acute or chronic) or planned to start RRT in the next 3 hours (according to the treating clinical team); or 7. Severe dysnatraemia (serum Na ≥ 155 mEq/L or \< 120 mEq/L); or 8. Hypokalaemia (serum K \< 2.5 mEq/L); or 9. Pulmonary oedema with PaO2 / FiO2 \< 100; or 10. Hypocalcaemia (iCa \< 0.8mmol/L); or 11. Patients admitted to the ICU after a drug overdose or intoxication (including alcohol intoxication); or 12. Pregnancy or breastfeeding; or 13. Death is deemed to be inevitable as a result of the current acute illness and either the treating clinician, the patient or the substitute decision maker are not committed to full active treatment; or 14. Patients with a life expectancy \< 30 days due to a chronic or underlying medical condition; or 15. Considered to be at high risk of cerebral oedema by the treating clinician (e.g. traumatic brain injury or acute brain disease); or 16. Clinician believes that being enrolled in intervention or control arm is not in the best interest of the patient; or 17. Previous enrolment in this study.

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Conditions

The condition(s) this trial relates to.

Acidosis metabolic acidosis Shock

As listed by the trial registrant

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

Metabolic acidosis Shock

Contacts and locations

Locations

  • Auckland City Hospital (CVICU)

    Auckland, Auckland, 1023, New Zealand

  • Auckland City Hospital (DCCM)

    Auckland, Auckland, 1023, New Zealand

  • Bendigo Hospital

    Bendigo, Victoria, 3550, Australia

  • Bunbury Regional Hospital

    Bunbury, Western Australia, 6230, Australia

  • Cairns Hospital

    Cairns, Queensland, 4870, Australia

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298, Australia

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605, Australia

  • Casey Hospital

    Berwick, Victoria, 3806, Australia

  • Centro de Estudos e de Pesquisas em Terapia Intensiva

    Curitiba, Paraná, 82530-200, Brazil

  • Christchurch Hospital

    Christchurch, Christchurch, 4710, New Zealand

  • Dandenong Hospital

    Dandenong, Victoria, 3175, Australia

  • Deep Hospital

    Ludhiana, Punjab, 141002, India

  • Dunedin Hospital

    Dunedin, Dunedin, 9016, New Zealand

  • Epworth

    Richmond, Victoria, 3121, Australia

  • Flinders Medical Centre

    Bedford Park, South Australia, Australia

  • Footscray Hospital

    Footscray, Victoria, 3011, Australia

  • Frankston Hospital

    Frankston, Victoria, 3199, Australia

  • Gold Coast University Hospital

    Southport, Queensland, 4215, Australia

  • Gosford Hospital

    Gosford, New South Wales, 2250, Australia

  • Grapmians Health

    Ballarat, Victoria, 3350, Australia

  • Ipswich Hospital

    Ipswich, Queensland, 4305, Australia

  • Jawaharlal Institute of Postgraduate Medical Education and Research

    Puducherry, Puducherry, 605006, India

  • King Abdullah International Medical Research Center

    Riyadh, Riyadh Region, 11481, Saudi Arabia

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia, 5112, Australia

  • Mater Hospital

    South Brisbane, Queensland, 4101, Australia

  • Middlemore Hospital

    Auckland, Auckland, 2025, New Zealand

  • Monash Medical Centre

    Clayton, Victoria, 3168, Australia

  • Nepean Hospital

    Kingswood, New South Wales, 2747, Australia

  • Orange Health Service

    Orange, New South Wales, 2800, Australia

  • Peninsula Private Hospital

    Langwarrin, Victoria, 3910, Australia

  • Princess Alexandra Hopsital

    Woolloongabba, Queensland, 4102, Australia

  • Queen Elizabeth II Jubilee Hospital

    Coopers Plains, Queensland, 4108, Australia

  • Rotorua Hospital

    Rotorua, Rotorua, 3010, New Zealand

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4006, Australia

  • Royal Darwin Hospital

    Tiwi, Northern Territory, 0810, Australia

  • Royal North Shore Hospital

    Saint Leonards, New South Wales, 2065, Australia

  • Royal Perth Hospital

    Perth, Western Australia, 6000, Australia

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050, Australia

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010, Australia

  • St. Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065, Australia

  • Sultan Qaboos Comprehensive Cancer Care and Research Center

    Seeb, Oman

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575, Australia

  • Sunshine Hospital

    St Albans, Victoria, 3021, Australia

  • Sutherland Hospital

    Caringbah, New South Wales, 2229, Australia

  • Sydney Adventist Hospital

    Wahroonga, New South Wales, 2076, Australia

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The Austin Hospital

    Heidelberg, Victoria, 3084, Australia

  • The Jikei University Hospital

    Minato, Tokyo, 105-0003, Japan

  • The Queen Elizabeth Hospital

    Woodville, South Australia, 5011, Australia

  • The Victorian Heart Hospital

    Clayton, Victoria, 3065, Australia

  • Townsville University Hospital

    Douglas, Queensland, 4814, Australia

  • University Hospital Geelong

    Geelong, Victoria, 3220, Australia

  • Waikato Hospital

    Hamilton, Hamilton, 3204, New Zealand

  • Wellington Regional Hospital

    Wellington, New Zealand

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