Metformin for Sepsis-Induced AKI

Recruiting in Palo Alto (17 mi)

Overseen byHernando Gomez, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Hernando Gomez

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing if metformin, a diabetes drug, can help patients with severe infections who develop kidney problems. The drug works by activating a protein that protects the kidneys. Researchers want to see if it is safe and effective for these patients. Metformin has been studied for its effects on kidney function, with some studies suggesting potential harmful effects and others indicating possible protective benefits.

Research Team

Hernando Gomez, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for adults in the ICU with sepsis or septic shock who can take oral medication and meet specific criteria indicating early-stage kidney injury due to sepsis. It's not for those with type 1 diabetes, advanced kidney injury, pregnancy, severe metabolic acidosis, recent metformin use, or expected short survival.

Inclusion Criteria

Available enteral access

I am older than 18 years.

I was admitted to the ICU for a severe infection with worsening health.

Exclusion Criteria

I have taken Metformin in the last 30 days.

Advanced directive to withhold life-sustaining treatment

The treating clinician believes that participation in the trial would not be in the best interests of the patient

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Treatment Details

Interventions

Metformin high dose (Biguanide)
Metformin low dose (Biguanide)
Placebo (Drug)

Trial OverviewThe study tests low and high doses of metformin against a placebo to see if it's safe and feasible for treating acute kidney injury caused by sepsis. This initial step could lead to larger trials assessing its effectiveness in reversing such injuries.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Metformin 500 mgExperimental Treatment1 Intervention

One 500mg tablet will be administered twice a day for the first (5) days of study treatment.

Group II: Metformin 1,000 mgExperimental Treatment1 Intervention

One 1,000mg tablet will be administered twice a day for the first (5) days of study treatment.

Group III: PlaceboPlacebo Group1 Intervention

One inactive tablet will be administered twice a day for the first (5) days of study treatment.