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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin Arm | Experimental | Melatonin 5 mg capsule by mouth at bedtime for the duration of hospitalization or discontinuation of broad spectrum antibiotics, whichever comes first. |
|
| Placebo Arm | Placebo Comparator | Placebo capsule by mouth at bedtime for the duration of hospitalization or discontinuation of broad spectrum antibiotics, whichever comes first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | Melatonin 5 mg capsule by mouth at bedtime |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Acute 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. | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Melatonin plasma trough concentration | Evaluate the steady state plasma trough concentration of melatonin | Days 3, 5, and 7 |
| Piperacillin/tazobactam plasma trough concentration | Evaluate the steady state plasma trough concentration of piperacillin/tazobactam |
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luigi Brunetti, PhD | Contact | 908-595-2645 | luigi.brunetti@rutgers.edu |
| Name | Affiliation | Role |
|---|---|---|
| Luigi Brunetti, PhD | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Wood Johnson University Hospital | Recruiting | New Brunswick | New Jersey | 08901 | United States |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo Capsule |
| Other |
Placebo capsule by mouth at bedtime |
|
| Days 3, 5, and 7 |
| Vancomycin plasma Area Under the Curve (AUC) | Evaluate the steady state plasma AUC of vancomycin | Days 3, 5, and 7 |
| Association between Kidney Injury Molecule-1 (KIM-1) and serum creatinine | Measure KIM-1 in plasma and urine and evaluate discordance between serum creatinine. | Days 3, 5, and 7 |
| Mitochondrial stress assessment via extracellular flux analysis to measure oxygen consumption rate of cells | Evaluate mitochondrial stress in peripheral blood mononuclear cells from a subset of subjects in each group. In addition, mitochondrial stress will be evaluated on day 3 in a subset in the melatonin group. | Days 1 and 3 |
| Urine mitochondrial DNA copy number | Measure mitochondrial DNA (mtDNA) in urine samples using polymerase chain reaction (PCR). | Days 1, 3, 5, and 7 |
| Fold-change in NRF-2 gene expression in peripheral blood mononuclear cells | Measure gene expression level at baseline and then on day 5 (or last day of study if earlier) using polymerase chain reaction (PCR) and compare the fold-change from baseline between groups. | Days 1 and 5 |
| Number of subjects with NRF2 DNA single nucleotide polymorphisms | Determination of the number of individuals with NRF2 DNA single nucleotide polymorphisms in the study population and compare the incidence of primary outcome in those with and without polymorphisms. | Day 1 |
| Number of subjects with KEAP1 DNA single nucleotide polymorphisms | Determination of the number of individuals with KEAP1 DNA single nucleotide polymorphisms in the study population and compare the incidence of primary outcome in those with and without polymorphisms. | Day 1 |
| Robert Wood Johnson University Hospital Somerset | Recruiting | Somerville | New Jersey | 08876 | United States |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D064419 | Chemically-Induced Disorders |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |