Health TrialsbyHealthPanel

Melatonin for Prevention of Kidney Injury

ConditionsAcute Kidney InjuryAdverse Drug Event
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRutgers, The State University of New Jersey

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Melatonin

    Drug

    Melatonin 5 mg capsule by mouth at bedtime

  • Placebo Capsule

    Other intervention

    Placebo capsule by mouth at bedtime

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Melatonin ArmExperimental treatment 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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

Secondary outcomes

Other outcomes

1

Melatonin plasma trough concentration

Evaluate the steady state plasma trough concentration of melatonin

Time frame
Days 3, 5, and 7
2

Piperacillin/tazobactam plasma trough concentration

Evaluate the steady state plasma trough concentration of piperacillin/tazobactam

Time frame
Days 3, 5, and 7
3

Vancomycin plasma Area Under the Curve (AUC)

Evaluate the steady state plasma AUC of vancomycin

Time frame
Days 3, 5, and 7
4

Association between Kidney Injury Molecule-1 (KIM-1) and serum creatinine

Measure KIM-1 in plasma and urine and evaluate discordance between serum creatinine.

Time frame
Days 3, 5, and 7

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rutgers, The State University of New Jersey

Lead sponsor

Source ClinicalTrials.gov
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