Could a common diabetes drug help kidneys in sepsis?
NCT ID NCT05900284
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether metformin, a common diabetes drug, is safe and practical to use for treating acute kidney injury caused by sepsis. Researchers gave low-dose metformin to 80 ICU patients with sepsis and kidney injury, monitoring for side effects and feasibility. The goal was to gather data for a larger future trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- metformin (low dose)
- What this could lead to
- If successful, this could point toward a new treatment for kidney injury in sepsis patients, potentially reducing deaths.
- What could go wrong
- This is a small, early-phase trial focused on safety and feasibility, not effectiveness. Metformin may cause side effects like low blood sugar or lactic acidosis in critically ill patients.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
80 people
The number who actually took part.
- Started
-
Nov 2023
- Finished
-
May 2026
- 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 Hide 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. Age \> 18 years 2. Admitted to the ICU with sepsis per sepsis 3 criteria (defined as suspected infection or initiation of anti-biotics plus an increase in SOFA ≥ 2 points) 3. Available enteral access Exclusion Criteria: 1. Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2 prior to study drug administration 2. Not expected to survive more than 24 hours 3. Advanced directive to withhold life-sustaining treatment 4. Metformin use in the last 30 days from admission (assessed by medical or refill prescription history, and by medication reconciliation) 5. The treating clinician believes that participation in the trial would not be in the best interests of the patient 6. Known or suspected pregnancy 7. On mechanical circulatory support of any kind 8. History of allergy to metformin 9. Having severe metabolic acidosis defined by a venous or arterial pH \< 7.2, with PaCO2 \< 45 or PvCO2 \< 50 mmHg at the time of enrolment. * Patients co-enrolled in observational studies will be eligible for enrollment in LiMiT AKI. However, patients enrolled in interventional studies will need to be assessed on an individual basis to define whether the patient will be eligible. * Children will be excluded from recruitment for this study. Etiologic causes of sepsis, acute kidney injury, and prognostic factors for children differ from those for adults; and for these reasons the proposed study focuses only on the adult population (age 18 years or older).
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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
-
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
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