Melatonin for Prevention of Kidney Injury

• Status: Not yet recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Treatments: Melatonin

Criteria

Inclusion criteria:

• Aged 18 to 65 years

• Currently prescribed vancomycin and piperacillin/tazobactam 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.