Prevention of Contrast Nephropathy by Sodium Bicarbonate Versus Sodium Chloride and N-acetylcysteine

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to assess the efficacy of sodium bicarbonate compared with sodium chloride and oral N-acetylcysteine (NAC ) pretreatment for prevention of contrast nephropathy in patients with advanced renal disease undergoing cardiac catheterisation.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shaare Zedek Medical Center
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

Eligible patients include individuals aged 18 year or older with GFR 15-60ml/min calculated by MDRD formula, who were scheduled to undergo cardiac catheterization. During the randomized study, consecutive eligible patients scheduled for exposure to the nonionic radiographic contrast agent iopamidol (796 mOsm/kg H2O, 755 mg of iopamidol per milliliter, and 370 mg iodine per milliliter) will be considered for enrollment.

Exclusion Criteria:

i. Serum creatinine levels more than 8mg/dl or GFR less than 15ml/min

ii. Change in serum creatinine levels of ³0.5mg/dl during the previous 24 hours.

iii. Preexisting dialysis

iv. Multiple myeloma.

v. Pulmonary edema.

vi. Uncontrolled hypertension (treated systolic blood pressure more than 160 mmHg, or diastolic blood pressure more than 100mmHg.)

vii. Emergency catheterization.

viii. Recent exposure to radiographic contrast (within two days of the study).

ix. Allergy to radiocontrast.

x. Pregnancy.

xi. Administration of dopamine, mannitol or NAC before the study.

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