Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.

Phase 4

Suspended

• Conditions: Cardiovascular Disease; Renal Insufficiency, Acute; Cardiopulmonary Bypass

• Registration Number: NCT00190034
• Lead Sponsor: Far Eastern Memorial Hospital

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 Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-19
• Status Verified: 2006-06
• Study Completion: 2007-06
• Last Update Submitted: 2009-02-06
• Last Update Posted: 2009-02-09

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• All patients who will received cardiac surgery with cardiopulmonary bypass

Exclusion Criteria

1. Dialyzed patients
2. Acute renal failure
3. Advanced left ventricular systolic dysfunction defined as left ventricular ejection fraction ≦ 35%.
4. Acute chronic obstructive lung disease or asthma exacerbation
5. Allergy to N-acetylcysteine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Serum creatinine and blood urea nitrogen: before, 48 h and 5 days after the operation procedure.

Trial Locations

Locations (1)

Far Eastern Memorial Hospital; 🇨🇳 Pan-Chiao, Taipei, Taiwan