Melatonin for Prevention of Kidney Injury

Launched by RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY · Oct 6, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether melatonin can help prevent kidney injury caused by the antibiotic vancomycin in hospitalized patients. Kidney injury can occur when certain medications are given, and this study aims to see if melatonin, a natural hormone that helps regulate sleep and has other health benefits, can reduce this risk. The researchers are currently looking for participants aged 18 to 75 who are receiving vancomycin for at least three days.

To be part of the study, patients must not have severe kidney or liver problems and should not be pregnant, breastfeeding, or have certain other serious health conditions. Participants will take melatonin and will be monitored for its safety and effectiveness in preventing kidney injury. It’s important for patients to know that they can still receive one dose of the antibiotic before agreeing to join the study, ensuring that their treatment is not delayed. The research team will provide support and information throughout the process to ensure a positive experience for all involved.

Gender

ALL

Eligibility criteria

• 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.