Status:
COMPLETED
Prevention of Contrast Nephropathy by Sodium Bicarbonate Versus Sodium Chloride and N-acetylcysteine
Lead Sponsor:
Shaare Zedek Medical Center
Conditions:
Acute Renal Failure Contrast Nephropathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 patien...
Detailed Description
PROTOCOL Prevention of Contrast Nephropathy by Sodium Bicarbonate Versus Sodium Chloride and N-Acetylcysteine Nephrology and Cardiology Services, Shaare Zedek Medical Center, Jerusalem 1. Backgroun...
Eligibility Criteria
Inclusion
- 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
- 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.
- \-
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00353340
Start Date
January 1 2005
End Date
May 1 2009
Last Update
February 25 2010
Active Locations (1)
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1
Shaare Zmc
Jerusalem, Israel, 91031