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| Sponsored by: |
Shaare Zedek Medical Center |
|---|---|
| Information provided by: | Shaare Zedek Medical Center |
| ClinicalTrials.gov Identifier: | NCT00353340 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Acute Renal Failure Contrast Nephropathy |
Drug: n acetylcystein Drug: sodium bicarbonate Drug: sodium chloride |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Bio-availability Study |
| Official Title: | Prevention of Contrast Nephropathy by Sodium Bicarbonate Versus Sodium Chloride and N-Acetylcysteine in Patients Undergoing Cardiac Catheterization |
| Estimated Enrollment: | 250 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | May 2007 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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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Contacts and Locations| Israel | |
| Shaare Zmc | Recruiting |
| jerusalem, Israel, 91031 | |
| Contact: linda shavit 026555086 lindashavit@yahoo.com | |
| Contact: Itzchak slotki, md 026555085 islotki@szmc.org.il | |
| Principal Investigator: linda shavit, md | |
| Principal Investigator: | linda shavit, md | Unaffiliated. |
More Information
| Study ID Numbers: | 70202 |
| Study First Received: | July 17, 2006 |
| Last Updated: | May 7, 2007 |
| ClinicalTrials.gov Identifier: | NCT00353340 History of Changes |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
|
sodium bicarbonate, n-acetylcistein,contrast nephropathy, cardiac catheterisation |
|
Anti-Infective Agents Renal Insufficiency Antioxidants Urologic Diseases Expectorants Acetylcysteine |
Renal Insufficiency, Acute Kidney Failure, Acute Kidney Diseases Antiviral Agents N-monoacetylcystine Kidney Failure |
|
Anti-Infective Agents Respiratory System Agents Renal Insufficiency Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Protective Agents Antiviral Agents Pharmacologic Actions Urologic Diseases |
Expectorants Therapeutic Uses Free Radical Scavengers Acetylcysteine Kidney Diseases Kidney Failure, Acute Renal Insufficiency, Acute N-monoacetylcystine Antidotes Kidney Failure |
