Melatonin for Prevention of Kidney Injury

Study Overview
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Brief Summary
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This study will evaluate the safety and effectiveness of melatonin for the prevention of antibiotic associated acute kidney injury in hospitalized patients.

Detailed Description
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Consenting subjects meeting inclusion and exclusion will be randomized to receive melatonin 5 mg daily or a matching placebo. Study subjects will be followed for the duration of hospitalization or discontinuation of broad spectrum antibiotics (vancomycin plus piperacillin/tazobactam). The primary outcome and secondary outcomes will be evaluated by the study team.

Official Title
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Melatonin for the Prevention of Antibiotic Associated Acute Kidney Injury

Conditions
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Acute Kidney Injury, Adverse Drug Event

Intervention / Treatment
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* Drug: Melatonin
* Other: Placebo Capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin Arm<br>Melatonin 5 mg capsule by mouth at bedtime for the duration of hospitalization or discontinuation of broad spectrum antibiotics, whichever comes first. | Drug: Melatonin<br>* Melatonin 5 mg capsule by mouth at bedtime<br>|
| Placebo Comparator: Placebo Arm<br>Placebo capsule by mouth at bedtime for the duration of hospitalization or discontinuation of broad spectrum antibiotics, whichever comes first. | Other: Placebo Capsule<br>* Placebo capsule by mouth at bedtime<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute kidney injury | Acute kidney injury will be defined as an increase in sCr from baseline of >/= 0.3 mg/dL or a >/= 50% increase from baseline. | 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 |