Melatonin for Prevention of Kidney Injury
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRutgers, The State University of New Jersey
About this trial
This study will evaluate the safety and effectiveness of melatonin for the prevention of antibiotic associated acute kidney injury in hospitalized patients.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Melatonin
- Placebo Capsule
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov