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

Phase 2
Recruiting
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
Registration Number
TCTR20210123004
Lead Sponsor
Cardiac Electrophysiology Research and Training Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
40
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

-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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Reduction of oxidative stress and acute kidney injury biomarker 12 months after end of the intervention Urine NGA
Secondary Outcome Measures
NameTimeMethod
Oxidative stress 12 months after end of the intervention Mitochondrial antioxidant and oxidative stress
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