Overview

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.