UMIN ID: UMIN000000581
Registered date:01/02/2007
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
Basic Information
Recruitment status | |
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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 |
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Secondary Outcome | Change in residual renal function after induction of dialysis therapy |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | 85years-old |
Gender | Male and Female |
Include criteria | |
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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | None |
Secondary ID(s) |
Contact
public contact | |
Name | Terumasa Hayashi |
Address | 2-23 Rinku-Orai Kita, Izumisano, Osaka Japan |
Telephone | 072-469-3111 |
t-hayashi@rgmc.izumisano.osaka.jp | |
Affiliation | Rinku General Medical Center, Izumisano Municipal Hospital Department of Nephrology |
scientific contact | |
Name | Terumasa Hayashi |
Address | 2-23 Rinku-Orai Kita, Izumisano, Osaka Japan |
Telephone | 072-469-3111 |
Affiliation | Rinku General Medical Center Izumisano Municipal Hospital Department of Nephrology |