Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | N-Acetylcysteine Protects Against Acute Renal Insult in Patients With Abnormal Renal Function Undergoing Cardiopulmonary Bypass. |
- Serum creatinine and blood urea nitrogen: before, 48 h and 5 days after the operation procedure.
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | June 2007 |
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:
- All patients who will received cardiac surgery with cardiopulmonary bypass
Exclusion Criteria:
- Dialyzed patients
- Acute renal failure
- Advanced left ventricular systolic dysfunction defined as left ventricular ejection fraction ≦ 35%.
- Acute chronic obstructive lung disease or asthma exacerbation
- Allergy to N-acetylcysteine
Contacts and Locations| Taiwan | |
| Far Eastern Memorial Hospital | |
| Pan-Chiao, Taipei, Taiwan, 220 | |
| Study Chair: | Shao-jung Li, M.D. | Far Eastern Memorial Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00190034 History of Changes |
| Other Study ID Numbers: | FEMH-93010, FEMH-93-C-030 |
| Study First Received: | September 11, 2005 |
| Last Updated: | February 6, 2009 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Far Eastern Memorial Hospital:
|
Acetylcysteine cardiac surgery cardiopulmonary bypass acute renal insufficiency |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Renal Insufficiency Acute Kidney Injury Kidney Diseases Urologic Diseases Acetylcysteine N-monoacetylcystine Antiviral Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes |
ClinicalTrials.gov processed this record on May 22, 2013