Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00190034
Recruitment Status : Suspended (opposite result)
First Posted : September 19, 2005
Last Update Posted : February 9, 2009
Synmosa Biopharma Corp.
Information provided by:
Far Eastern Memorial Hospital

September 11, 2005
September 19, 2005
February 9, 2009
January 2005
Not Provided
Serum creatinine and blood urea nitrogen: before, 48 h and 5 days after the operation procedure.
Same as current
Complete list of historical versions of study NCT00190034 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.
N-Acetylcysteine Protects Against Acute Renal Insult in Patients With Abnormal Renal Function Undergoing Cardiopulmonary Bypass.
The purpose of this study is to determine whether N-acetylcysteine is effective in the prophylaxis of post-cardiopulmonary bypass acute renal impairment.

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
  • Cardiovascular Disease
  • Renal Insufficiency, Acute
  • Cardiopulmonary Bypass
Drug: N-Acetylcysteine 600mg/tab
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2007
Not Provided

Inclusion Criteria:

  • All patients who will received cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

  1. Dialyzed patients
  2. Acute renal failure
  3. Advanced left ventricular systolic dysfunction defined as left ventricular ejection fraction ≦ 35%.
  4. Acute chronic obstructive lung disease or asthma exacerbation
  5. Allergy to N-acetylcysteine
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Not Provided
Far Eastern Memorial Hospital
Synmosa Biopharma Corp.
Study Chair: Shao-jung Li, M.D. Far Eastern Memorial Hospital
Far Eastern Memorial Hospital
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP