Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|