What side effects are associated with this type of intervention?

Common treatments for sepsis include antibiotics, AMPK activators like Metformin, and supportive therapies. Antibiotics can cause side effects such as allergic reactions, gastrointestinal disturbances, and antibiotic resistance. AMPK activators, like Metformin, may lead to gastrointestinal upset, lactic acidosis, and potential renal impairment. Supportive therapies, including fluid resuscitation and vasopressors, can result in fluid overload, electrolyte imbalances, and cardiovascular complications. It is essential to monitor patients closely to manage these side effects effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for sepsis, primarily focusing on antibiotics and supportive care measures such as vasopressors and intravenous fluids. Antibiotics like vancomycin, ceftriaxone, and piperacillin-tazobactam are commonly used to treat the underlying infections causing sepsis. Vasopressors such as norepinephrine and dopamine are used to manage septic shock by maintaining blood pressure. While Metformin, which activates AMP-activated protein kinase (AMPK), is being studied for its potential benefits in sepsis, there are no FDA-approved treatments specifically targeting AMPK activation for sepsis management at this time.

What other types of research exist?

Promising novel alternatives to Metformin for sepsis patients include Gliptins and GLP-1 analogs. These drugs have shown potential in improving survival and reducing vascular inflammation/dysfunction in animal models of endotoxemia, which may warrant further clinical evaluation in sepsis treatment.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline, day 1, 3, 5

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.

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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.