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Kidney shield? diabetes drug tested to prevent ICU kidney failure

NCT ID NCT05468203

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 tested whether dapagliflozin, a drug used for diabetes and chronic kidney disease, could prevent acute kidney injury in critically ill patients in the intensive care unit (ICU). The trial planned to enroll 3,000 adults but was terminated early after only 51 participants. Patients were randomly assigned to receive either dapagliflozin or a placebo daily for up to 30 days while in the ICU.

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

51 people

The number who actually took part.

Started

Nov 2023

Finished

Dec 2025

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: * Age 18 years or more * Admitted to ICU within the last 7 days * Expected to be in the ICU the day after tomorrow * An arterial or central venous catheter is in situ, or placement is planned for routine management * Able to receive study treatment orally or via enteral route * At least one of the following risk factors for AKI: * Required fluid resuscitation, defined as a bolus of fluid prescribed to be given over ≤1 hour to increase or maintain intravascular volume that is in addition to maintenance fluids * Being treated with continuous vasopressors or inotropes to maintain a systolic blood pressure \> 90mmHg, or mean arterial blood pressure \> 60mmHg or a MAP target set by the treating clinician for maintaining perfusion * At least one of the following pre-morbid risk factors: * Treatment for high blood pressure * Treatment for type 2 diabetes (minimum diet therapy) * Atherosclerotic cardiovascular disease * History of heart failure * Impaired renal function, defined as an eGFR between 20 - 60 mL/min/1.73m2 * Estimated BMI 30 kg/m2 or more * Age 60 years or more Exclusion Criteria: * Met all inclusion criteria more than 24 hours ago * History of type 1 diabetes mellitus or diabetic ketoacidosis * COVID-19 infection as the reason for ICU admission * Requiring renal replacement therapy for intoxication * eGFR less than 20 mL/min/1.73m2 * Known hypersensitivity to any SGLT-2 inhibitor e.g. dapagliflozin, canagliflozin, empagliflozin, ertugliflozin * Solid organ transplantation within the last 12 months * Likely to be transferred to another hospital in the next 3 days * Known or suspected pregnancy * Death is deemed imminent or inevitable * Life expectancy is estimated to be less than 90 days * Patient or the treating clinician declines to participate * Enrolled in another interventional trial for which co-enrolment is not approved * Patient has previously been enrolled in the PREVENTS-AKI Study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Austin Health

    Heidelberg, Victoria, 3084, Australia

  • Epworth Richmond

    Richmond, Victoria, 3121, Australia

  • Grampians Health

    Ballarat, Victoria, 3350, Australia

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