Using melatonin to prevent kidney injury in hospitalized patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of melatonin in preventing acute kidney injury associated with antibiotic treatment in hospitalized patients. Participants aged 18 to 75 who are prescribed vancomycin will be randomly assigned to receive either melatonin or a placebo daily. The study will monitor patients throughout their hospitalization or until they stop taking broad-spectrum antibiotics. The primary and secondary outcomes will be assessed by the research team to determine the impact of melatonin on kidney health.

Why it matters

Who can join: the full rules

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.

Where it's running

• Robert Wood Johnson University Hospital
  New Brunswick, New Jersey, United States Recruiting
• Robert Wood Johnson University Hospital Somerset
  Somerville, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Luigi Brunetti, PhD — Rutgers, The State University of New Jersey
• Study coordinator: Luigi Brunetti, PhD
• Email: luigi.brunetti@rutgers.edu
• Phone: 908-595-2645

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.