Back to Trials
NCT05084196PHASE3Recruiting

Melatonin for Prevention of Kidney Injury

Rutgers, The State University of New Jersey

Start Date

6/5/2023

Completion Date

12/31/2027

Summary

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

Detailed Description

Consenting subjects meeting inclusion and exclusion will be randomized to receive melatonin 5 mg daily or a matching placebo. Study subjects will be followed for the duration of hospitalization or discontinuation of broad spectrum antibiotics (vancomycin plus piperacillin/tazobactam). The primary outcome and secondary outcomes will be evaluated by the study team.

Eligibility Criteria

Age Range: 18 years to 75 years

Inclusion criteria: * Aged 18 to 75 years * Currently prescribed vancomycin with the presumption that therapy will be continued for at least 3 days based on a review of subject status. Because of the critical nature of starting empiric broad-spectrum antibiotics, we will allow one dose of the antibiotic combination before consent and enrollment. This strategy is necessary for the ethical conduct of the study. Exclusion criteria: * Estimated creatinine clearance \< 30 mL/min * Liver impairment (liver enzymes \> 3 times upper limit) * Any history of allergy or contraindication to melatonin * Pregnancy or breastfeeding * Autoimmune disease * Requiring vasopressors * Requiring mechanical ventilation * History of acute kidney injury in the past 30 days * Inability to take oral medications * Clinical evidence of significant unstable or uncontrolled illness which, in the opinion of the research team, could confound the results of the study or put the patient at undue risk.

Interventions

DRUG

Melatonin

OTHER

Placebo Capsule

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Acute Kidney InjuryAdverse Drug Event

Locations

Robert Wood Johnson University Hospital

New Brunswick, New Jersey 08901

United States

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey 08876

United States