Melatonin for Prevention of Kidney Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Melatonin, Placebo Capsule.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury, Adverse Drug Event. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Melatonin for the Prevention of Antibiotic Associated Acute Kidney Injury
Overview
This study will evaluate the safety and effectiveness of melatonin for the prevention of antibiotic associated acute kidney injury in hospitalized patients.
Detailed description
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.
Interventions
- Drug Melatonin
Melatonin 5 mg capsule by mouth at bedtime - Other Placebo Capsule
Placebo capsule by mouth at bedtime
Primary outcome measures
- Acute kidney injury [Time frame: 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- Robert Wood Johnson University Hospital — New Brunswick
- Robert Wood Johnson University Hospital Somerset — Somerville
Identifiers
NCT: NCT05084196 · Pro2021001502