Safety and Feasibility of Metformin for Sepsis Induced AKI

• Status: Not yet recruiting
• Trial end date: 2026-12-21
• Target enrollment: 0
• Participant gender: All

Summary

Acute kidney injury (AKI) is an independent risk factor for death that affects 10-15% of hospitalized patients and more than 50% of patients admitted to the intensive care unit. Sepsis is the most frequent cause of AKI, affecting 48 million people worldwide every year, and accounting for approximately 11 million of annual global deaths. Despite these figures, there are no known therapies to prevent or reverse septic AKI; hence this study aims to establish the safety and feasibility of the implementation of metformin in the treatment of AKI in patients with sepsis.

This study is the first critical step to inform the design of a future, full-scale efficacy RCT.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hernando Gomez
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Patients >=18 years of age

• Admitted to the Intensive Care Unit

• Septic defined by Sepsis 3 criteria or septic shock defined as patients with sepsis with persistent hypotension requiring vasopressors to maintain a MAP >=65 mmHg, and having serum lactate >= 2 mmol/L despite adequate volume resuscitation.

• Able to take oral medication through any enteral access (including but not limited to naso/oro gastric/duodenal tube or gastrostomy tube).

Exclusion Criteria:

• Patients with pre-existing diabetes type 1.

• Evidence of moderate to severe AKI (KDIGO stage 2 or 3) at admission to the ICU

• Patients not expected to survive more than 24h after admission to the ICU

• The decision to withhold life-sustaining treatment, not including those patients committed to full support except cardiopulmonary resuscitation

• Using metformin at the time of admission or within the last month

• Physician strongly believes that the study treatment will not be continued according to the study protocol

• Confirmed pregnancy

• Patients treated with extracorporeal membrane oxygenation (ECMO) or with ventricular assist devices (VAD)

• Organ donors with a neurological determination of death

• Patients with history of allergy to metformin

• Patients in chronic dialysis use

• Patients with estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 in prior 30 days

• Patients with severe metabolic acidosis defined by a pH < 7.2