NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedPatients with advanced CKD planned to dialysis therapy
Date of first enrollment2007/02/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeChange in creatinine clearance, serum creatinine and urine volume during two weeks after radio-contrast agent administration
Secondary OutcomeChange in residual renal function after induction of dialysis therapy

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum85years-old
GenderMale and Female
Include criteria
Exclude criteria1)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

Contact

public contact
Name Terumasa Hayashi
Address 2-23 Rinku-Orai Kita, Izumisano, Osaka Japan
Telephone 072-469-3111
E-mail 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
E-mail
Affiliation Rinku General Medical Center Izumisano Municipal Hospital Department of Nephrology