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Protective effects of melatonin on kidney function against contrast media-induced kidney damage in patients with chronic kidney disease: A prospective, randomized, double-blinded, placebo-controlled trial

Effect of melatonin on the reduction of oxidative stress and the prevention of contrast-induced acute kidney injury

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210123004
Enrollment
40
Registered
2021-01-23
Start date
2021-01-11
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing PCI with chronic kidney disease stage 3-5 (non-dialysis) with estimated glomerular filtration rate (eGFR) below than 60 mL/min/1.73 m2 measured by CKD-EPI method Contrast-induced acute kidney injury, Oxidative stress, Mitochondria, Prevention, Melatonin

Interventions

Melatonin slow release 10 mg (Natrol, Natrol LLC, USA) will be started at the dose of 10 mg twice a day orally at 48 hours prior to PCI and continue up to 72 hours after PCI in totally 6 doses if they
Active Comparator Drug,Placebo Comparator Drug

Sponsors

Cardiac Electrophysiology Research and Training Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age more than 18 years old 2. Undergoing PCI 3. CKD stage 3-5 (non-dialysis) with estimated glomerular filtration rate (eGFR) below than 60 mL/min/1.73 m2 measured by CKD-EPI method

Exclusion criteria

Exclusion criteria: - ESRD on long term renal replacement therapy - AKI with renal replacement therapy - Receiving contrast media within 5 days - Acute coronary syndrome within 5 days - Acute decompensated heart failure - Life-threatening cardiac arrhythmia (including ventricular tachycardia and ventricular fibrillation) - Cardiac arrest - Cardiogenic shock - Sepsis or septic shock - Active malignancy - Volume of contrast in mL <3 times of eGFR - Lupus nephritis - Autosomal dominant polycystic kidney disease - Severe anemia with hemoglobin <7 mg/dL - Prior treatment with melatonin and other antioxidants; such as vitamin C, curcumin, and herbal medicine; in past 5 days

Design outcomes

Primary

MeasureTime frame
Incidence of CI-AKI 7 days after intervention Chi squre test

Secondary

MeasureTime frame
Oxidative stress 7 days after end of the intervention Mitochondrial antioxidant and oxidative stress

Countries

Thailand

Contacts

Public ContactPrit Kusirisin

Chiang Mai University

jingprit@hotmail.com0897574028

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026