Safety and Feasibility of Metformin for Sepsis Induced AKI (NCT05900284) | Clinical Trial Compass
CompletedPhase 2
Safety and Feasibility of Metformin for Sepsis Induced AKI
United States80 participantsStarted 2023-11-08
Plain-language 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 randomized clinical trial.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age \> 18 years
. 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)
. Available enteral access
Exclusion criteria
. Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2 prior to study drug administration
. Not expected to survive more than 24 hours
. Advanced directive to withhold life-sustaining treatment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial has already completed and was focused on whether metformin is safe and practical to use in sepsis-related kidney injury, has my doctor seen any of the results yet, and what do those early safety signals suggest about risks like low blood sugar, high lactate levels, or stomach problems?
2Because this was a Phase 2 study primarily designed to test safety and feasibility rather than prove that metformin actually improves outcomes, does my doctor think the evidence is strong enough yet to consider metformin as part of my care, or is standard treatment still the better-supported path right now?
3Metformin is typically avoided in people with kidney problems because of concerns about a condition called lactic acidosis — so how would my doctor weigh those existing concerns against whatever this trial found about its use in sepsis-related acute kidney injury?
4Given that the trial tracked why some patients or their families declined to enroll, can my doctor help me understand what the common concerns were, so I can think through whether any of those same concerns apply to my situation?
5If there is a follow-up Phase 3 trial planned based on these completed results, would my doctor consider that worth exploring, and in the meantime what is the current standard of care for managing sepsis-related acute kidney injury?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The development of metformin associated serious adverse events (mSAE) which will include hyperlactatemia, hypoglycemia, metabolic acidosis and/or gastrointestinal intolerance during the treatment period
Timeframe: Hospital discharge or 30 days, whatever occurs first
2
Feasibility: Recruitment, retention and adherence
Timeframe: Hospital discharge or 30 days, whatever occurs first
3
Feasibility: Investigating the reasons for denial of enrollment by patients, surrogates or clinicians
Timeframe: Hospital discharge or 30 days, whatever occurs first
4
Feasibility: Data accrual and loss to follow-up
Timeframe: Hospital discharge or 30 days, whatever occurs first