RecruitingPhase 3NCT05084196

Melatonin for Prevention of Kidney Injury

Melatonin for the Prevention of Antibiotic Associated Acute Kidney Injury


Sponsor

Rutgers, The State University of New Jersey

Enrollment

300 participants

Start Date

Jun 5, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate the safety and effectiveness of melatonin for the prevention of antibiotic associated acute kidney injury in hospitalized patients.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether melatonin — a natural sleep hormone widely available as a supplement — can prevent kidney injury in patients who are being treated with vancomycin, a powerful antibiotic that is known to sometimes damage the kidneys. Melatonin's antioxidant properties may help protect kidney cells during antibiotic treatment. You may be eligible if... - You are between 18 and 75 years old - You are currently receiving vancomycin and are expected to continue for at least 3 days You may NOT be eligible if... - Your estimated kidney function (creatinine clearance) is below 30 mL/min - You have liver impairment (liver enzymes more than 3 times the upper limit of normal) - You have any allergy or contraindication to melatonin - You are pregnant or breastfeeding - You have an autoimmune disease - You currently require vasopressors (blood pressure–supporting medications) or mechanical ventilation - You had an acute kidney injury in the past 30 days - You are unable to take oral medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMelatonin

Melatonin 5 mg capsule by mouth at bedtime

OTHERPlacebo Capsule

Placebo capsule by mouth at bedtime


Locations(2)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, United States

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NCT05084196


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