Melatonin for Prevention of Kidney Injury (NCT05084196) | Clinical Trial Compass
RecruitingPhase 3
Melatonin for Prevention of Kidney Injury
United States300 participantsStarted 2023-06-05
Plain-language summary
This study will evaluate the safety and effectiveness of melatonin for the prevention of antibiotic associated acute kidney injury in hospitalized patients.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
What they're measuring
1
Acute kidney injury
Timeframe: From date of randomization until the date of first documented acute kidney injury or date of antibiotic discontinuation, whichever came first, assessed up to 28 days
Trial details
NCT IDNCT05084196
SponsorRutgers, The State University of New Jersey