RecruitingPhase 3NCT05084196
Melatonin for Prevention of Kidney Injury
Melatonin for the Prevention of Antibiotic Associated Acute Kidney Injury
Sponsor
Rutgers, The State University of New Jersey
Enrollment
300 participants
Start Date
Jun 5, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
This study will evaluate the safety and effectiveness of melatonin for the prevention of antibiotic associated acute kidney injury in hospitalized patients.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria2
- 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 Criteria10
- 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.
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Interventions
DRUGMelatonin
Melatonin 5 mg capsule by mouth at bedtime
OTHERPlacebo Capsule
Placebo capsule by mouth at bedtime
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05084196
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