Acetylcysteine Against Acute Renal Insult During 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.
Renal Insufficiency, Acute
Drug: N-Acetylcysteine 600mg/tab
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
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.
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190034
|Far Eastern Memorial Hospital|
|Pan-Chiao, Taipei, Taiwan, 220|
|Study Chair:||Shao-jung Li, M.D.||Far Eastern Memorial Hospital|