N-Acetylcysteine Protects Against Acute Renal Insult in Patients With Abnormal Renal Function Undergoing Cardiopulmonary Bypass.
Trial Snapshot
- Phase
- Phase 4
- Status
- Suspended
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Serum creatinine and blood urea nitrogen: before, 48 h and 5 days after the operation procedure.
Study Overview
Brief Summary
The purpose of this study is to determine whether N-acetylcysteine is effective in the prophylaxis of post-cardiopulmonary bypass acute renal impairment.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Serum creatinine and blood urea nitrogen: before, 48 h and 5 days after the operation procedure.
Secondary Outcomes
No secondary outcomes reported