Title
Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.
N-Acetylcysteine Protects Against Acute Renal Insult in Patients With Abnormal Renal Function Undergoing Cardiopulmonary Bypass.
Phase
Phase 4Lead Sponsor
Far Eastern Memorial HospitalStudy Type
InterventionalStatus
SuspendedIndication/Condition
Cardiovascular Disease Renal Insufficiency, Acute Cardiopulmonary BypassIntervention/Treatment
acetylcysteine ...Study Participants
60The 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.
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
