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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

Awards & highlights

Study Summary

This trial aims to find if a drug, metformin, can help prevent or reverse septic AKI, a condition that affects many hospitalized patients and causes 11 million deaths globally each year.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hernando GomezLead Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,358 Previous Clinical Trials

4,315,161 Total Patients Enrolled

3 Trials studying Sepsis

456 Patients Enrolled for Sepsis

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,459 Total Patients Enrolled

13 Trials studying Sepsis

9,664 Patients Enrolled for Sepsis

Media Library

Metformin high dose (Biguanide) Clinical Trial Eligibility Overview. Trial Name: NCT05900284 — Phase 2

Sepsis Research Study Groups: Metformin 1,000 mg, Metformin 500 mg, Placebo

Sepsis 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent could Metformin 500 mg be considered a risk for patients?

"Considering the Phase 2 status of Metformin 500 mg, our team concluded it is relatively safe and assigned a score of 2. However, we need more data to determine its efficacy."

Answered by AI

Are there any vacancies available for participation in this experiment?

"The public information on clinicaltrials.gov indicates this trial is no longer recruiting patients as of June 2nd, 2023. Despite the abrupt halt in recruitment for this particular study, there are still 375 other medical trials actively seeking participants at present time."

Answered by AI

What outcomes are investigators striving to achieve in this experiment?

"The primary objective of this clinical trial, which will be checked over the course of a month or until hospital discharge, is to assess feasibility: specifically, analyzing any rejection for enrolment by patients and their clinicians. Secondary goals involve tracking metformin accumulation levels from blood samples on day 5 after administration (pharmacokinetic accumulation profile), measuring absorption kinetics from Day 2 testing (pharmacokinetic absorption profile), and observing platelet bioenergetic profiles with the Seahorse Analyzer in participants from each treatment arm (change in platelet mitochondrial respiration)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Feasibility of Metformin for Sepsis Induced AKI

Hernando Gomez 2023. "Safety and Feasibility of Metformin for Sepsis Induced AKI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05900284.

All > Sepsis