Melatonin for Prevention of Kidney Injury

Description

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

Conditions

Acute Kidney Injury, Adverse Drug Event

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Study Overview

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Study Details

Study overview

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

Melatonin for the Prevention of Antibiotic Associated Acute Kidney Injury

Melatonin for Prevention of Kidney Injury

Condition
Acute Kidney Injury
Intervention / Treatment

-

Contacts and Locations

New Brunswick

Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States, 08901

Somerville

Robert Wood Johnson University Hospital Somerset, Somerville, New Jersey, United States, 08876

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Rutgers, The State University of New Jersey,

Luigi Brunetti, PhD, PRINCIPAL_INVESTIGATOR, Rutgers, The State University of New Jersey

Study Record Dates

2026-12-31