Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.
Primary Purpose
Cardiovascular Disease, Renal Insufficiency, Acute, Cardiopulmonary Bypass
Status
Suspended
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
N-Acetylcysteine 600mg/tab
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Disease focused on measuring Acetylcysteine, cardiac surgery, cardiopulmonary bypass, acute renal insufficiency
Eligibility Criteria
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
Sites / Locations
- Far Eastern Memorial Hospital
Outcomes
Primary Outcome Measures
Serum creatinine and blood urea nitrogen: before, 48 h and 5 days after the operation procedure.
Secondary Outcome Measures
Full Information
NCT ID
NCT00190034
First Posted
September 11, 2005
Last Updated
February 6, 2009
Sponsor
Far Eastern Memorial Hospital
Collaborators
Synmosa Biopharma Corp.
1. Study Identification
Unique Protocol Identification Number
NCT00190034
Brief Title
Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.
Official Title
N-Acetylcysteine Protects Against Acute Renal Insult in Patients With Abnormal Renal Function Undergoing Cardiopulmonary Bypass.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2006
Overall Recruitment Status
Suspended
Why Stopped
opposite result
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Far Eastern Memorial Hospital
Collaborators
Synmosa Biopharma Corp.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether N-acetylcysteine is effective in the prophylaxis of post-cardiopulmonary bypass acute renal impairment.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Renal Insufficiency, Acute, Cardiopulmonary Bypass
Keywords
Acetylcysteine, cardiac surgery, cardiopulmonary bypass, acute renal insufficiency
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
N-Acetylcysteine 600mg/tab
Primary Outcome Measure Information:
Title
Serum creatinine and blood urea nitrogen: before, 48 h and 5 days after the operation procedure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shao-jung Li, M.D.
Organizational Affiliation
Far Eastern Memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Far Eastern Memorial Hospital
City
Pan-Chiao
State/Province
Taipei
ZIP/Postal Code
220
Country
Taiwan
12. IPD Sharing Statement
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Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.
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