RECRUITING

Melatonin for Prevention of Kidney Injury

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Melatonin for the Prevention of Antibiotic Associated Acute Kidney Injury

Quick Facts

Study Start:2023-06-05

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05084196

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Luigi Brunetti, PhD

CONTACT

908-595-2645

luigi.brunetti@rutgers.edu

Principal Investigator

Luigi Brunetti, PhD

PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Study Locations (Sites)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901

United States

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, 08876

United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

Luigi Brunetti, PhD, PRINCIPAL_INVESTIGATOR, Rutgers, The State University of New Jersey

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-05

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-06-05

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

Acute Kidney Injury
Adverse Drug Event