An Open-label Controlled Trial to Assess the Prophylactic Efficacy of N-Acetylcysteine on Radio-contrast Induced Nephropathy in Patients With Advanced Chronic Kidney Disease Planned to Start Dialysis Therapy

UMIN ID: UMIN000000581

Registered date:01/02/2007

Basic Information

• Health condition(s) or Problem(s) studied: Patients with advanced CKD planned to dialysis therapy
• Date of first enrollment: 2007/02/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Oral administration of N-Acetylcysteine
Saline infusion at a rate of 1 ml/kg/hour for 12 hours before and after radiocontrast agent administration

Outcome(s)

• Primary Outcome: Change in creatinine clearance, serum creatinine and urine volume during two weeks after radio-contrast agent administration
• Secondary Outcome: Change in residual renal function after induction of dialysis therapy

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: 1)Contraindicated to radiocontrast agent or N-Acetylcysteine 2)Malignancy 3)Congestive heart failure(NYHA III, IV) 4)Acute myocardial infarction, pulmonary embolism and cerebral infarction within 6 months 5)Diastolic blood pressure of 100 mmHg or more

Related Information

• Primary Sponsor: Department of Nephrology, Rinku General Medical Center Izumisano Municipal Hospital
• Source(s) of Monetary Support: None