Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.
|ClinicalTrials.gov Identifier: NCT00190034|
Recruitment Status : Suspended (opposite result)
First Posted : September 19, 2005
Last Update Posted : February 9, 2009
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease Renal Insufficiency, Acute Cardiopulmonary Bypass||Drug: N-Acetylcysteine 600mg/tab||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||N-Acetylcysteine Protects Against Acute Renal Insult in Patients With Abnormal Renal Function Undergoing Cardiopulmonary Bypass.|
|Study Start Date :||January 2005|
|Estimated Study Completion Date :||June 2007|
- Serum creatinine and blood urea nitrogen: before, 48 h and 5 days after the operation procedure.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00190034
|Far Eastern Memorial Hospital|
|Pan-Chiao, Taipei, Taiwan, 220|
|Study Chair:||Shao-jung Li, M.D.||Far Eastern Memorial Hospital|