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| Sponsors and Collaborators: |
Far Eastern Memorial Hospital SYNMOSA BIOPHARMA |
|---|---|
| Information provided by: | Far Eastern Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT00190034 |
Purpose
The purpose of this study is to determine whether N-acetylcysteine is effective in the prophylaxis of post-cardiopulmonary bypass acute renal impairment.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Disease Renal Insufficiency, Acute Cardiopulmonary Bypass |
Drug: N-Acetylcysteine 600mg/tab |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | N-Acetylcysteine Protects Against Acute Renal Insult in Patients With Abnormal Renal Function Undergoing Cardiopulmonary Bypass. |
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | June 2006 |
BACKGROUND Reactive oxygen species have been shown to cause contrast-induced nephrotoxicity (CIN). According to previous studies, the N-acetylcysteine has been proved to be advantageous in the avoidance of CIN. We seek to evaluate the efficacy of the antioxidant N-acetylcysteine in limiting the nephrotoxicity after cardiovascular surgery with cardiopulmonary bypass.
METHODS We will prospectively study 60 patients who will receive a cardiovascular surgery with cardiopulmonary bypass. Patients will be randomly assigned to receive either N-acetylcysteine (600 mg orally twice daily for 4 doses) with 0.45% saline intravenously, before and after cardiopulmonary bypass, or placebo with 0.45% saline. Serum creatinine and blood urea nitrogen will be measured before, 48 h and 5 days after the operation procedure.
Expected results Prophylactic oral administration of the antioxidant N-acetylcysteine, along with hydration, will significantly reduce the acute renal damage induced by CPB in patients with chronic renal insufficiency that need cardiovascular procedures.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Shao-jung Li, M.D. | 886-2-8966-7000 ext 1618 | shaojung@ms24.hinet.net |
| Taiwan, Taipei | |
| Far Eastern Memorial Hospital | Recruiting |
| Pan-Chiao, Taipei, Taiwan, 220 | |
| Contact: Shu-Hsun Chu, M.D. 866-2-8966-7000 | |
| Study Chair: | Shao-jung Li, M.D. | Far Eastern Memorial Hospital |
| Study Chair: | Shao-jung Li, M.D. | Far Eastern Memorial Hospital |
More Information
| Study ID Numbers: | FEMH-93010, FEMH-93-C-030 |
| Study First Received: | September 11, 2005 |
| Last Updated: | March 5, 2006 |
| ClinicalTrials.gov Identifier: | NCT00190034 |
| Health Authority: | Taiwan: Department of Health |
|
Acetylcysteine cardiac surgery cardiopulmonary bypass acute renal insufficiency |
|
Renal Insufficiency Urologic Diseases Acetylcysteine |
Kidney Diseases Renal Insufficiency, Acute N-monoacetylcystine |
|
Respiratory System Agents Anti-Infective Agents Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antiviral Agents Protective Agents |
Pharmacologic Actions Expectorants Therapeutic Uses Free Radical Scavengers Cardiovascular Diseases Antidotes |
