This study will evaluate the safety and effectiveness of melatonin for the prevention of antibiotic associated acute kidney injury in hospitalized patients.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
300
Melatonin 5 mg capsule by mouth at bedtime
Placebo capsule by mouth at bedtime
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
RECRUITINGRobert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States
RECRUITINGAcute 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.
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.