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Biguanide

Metformin for Sepsis-Induced AKI

Phase 2
Waitlist Available
Led By Hernando Gomez, MD
Research Sponsored by Hernando Gomez
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline, day 1, 3, 5

Summary

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.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
While the trial aims to establish safety, potential side effects of metformin may include digestive issues like nausea or diarrhea, risk of lactic acidosis (a rare but serious condition), vitamin B12 deficiency over long-term use, and skin reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline, day 1, 3, 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline, day 1, 3, 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility: Data accrual and loss to follow-up
Feasibility: Investigating the reasons for denial of enrollment by patients, surrogates or clinicians
Feasibility: Recruitment, retention and adherence
+1 more
Secondary study objectives
Acute Kidney Injury at day 30 or discharge
Acute Kidney Injury at day 7
Area under the curve of the concentration of the renal biomarker TIMP2 (Time Point 2)/ Insulin-like growth factor-binding protein (IGFBP7) in time
+6 more

Trial Design

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for sepsis include antimicrobial therapy, fluid resuscitation, and vasopressors. Antimicrobial therapy aims to eradicate the infection by targeting a broad spectrum of likely pathogens, which is crucial for controlling the source of sepsis. Fluid resuscitation helps to maintain blood pressure and organ perfusion, counteracting the effects of septic shock. Vasopressors, such as norepinephrine, are used when fluid resuscitation is insufficient to maintain blood pressure, ensuring vital organs receive adequate blood flow. Additionally, the activation of AMP-activated protein kinase (AMPK) by agents like Metformin is being studied for its potential to ameliorate sepsis-induced organ damage, such as acute kidney injury, by improving cellular energy homeostasis and reducing inflammation. These treatments are vital as they address both the infection and the systemic effects of sepsis, improving patient outcomes.
Activation of AMP-Activated Protein Kinase by A769662 Ameliorates Sepsis-Induced Acute Lung Injury in Adult Mice.

Find a Location

Who is running the clinical trial?

Hernando GomezLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,455 Previous Clinical Trials
4,335,028 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,826 Previous Clinical Trials
8,166,476 Total Patients Enrolled
Hernando Gomez, MDPrincipal InvestigatorUniversity of Pittsburgh

Media Library

Metformin high dose (Biguanide) Clinical Trial Eligibility Overview. Trial Name: NCT05900284 — Phase 2
Acute Kidney Failure Research Study Groups: Metformin 1,000 mg, Metformin 500 mg, Placebo
Acute Kidney Failure Clinical Trial 2023: Metformin high dose Highlights & Side Effects. Trial Name: NCT05900284 — Phase 2
Metformin high dose (Biguanide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05900284 — Phase 2
~40 spots leftby Feb 2026