๐ฌIn plain words
What the trial is, and whether it could suit you
This study will evaluate the safety and effectiveness of melatonin for the prevention of antibiotic associated acute kidney injury in hospitalized patients.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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.
Robert Wood Johnson University Hospital
New Brunswick, United States
Robert Wood Johnson University Hospital Somerset
Somerville, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.