Melatonin for Prevention of Kidney Injury

Rutgers The State University of New Jersey

Status and phase: Enrolling; Phase 3

Conditions: Adverse Drug Event; Acute Kidney Injury

Treatments: Other: Placebo Capsule; Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT05084196

Pro2021001502

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups, including a placebo group

Melatonin Arm

Experimental group

Description:

Melatonin 5 mg capsule by mouth at bedtime for the duration of hospitalization or discontinuation of broad spectrum antibiotics, whichever comes first.

Treatment:

Drug: Melatonin

Placebo Arm

Placebo Comparator group

Description:

Placebo capsule by mouth at bedtime for the duration of hospitalization or discontinuation of broad spectrum antibiotics, whichever comes first.

Treatment:

Other: Placebo Capsule