Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.

Cardiovascular Disease Clinical Trial

Official title:

N-Acetylcysteine Protects Against Acute Renal Insult in Patients With Abnormal Renal Function Undergoing Cardiopulmonary Bypass.

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00190034
• Other study ID #: FEMH-93010
• Secondary ID: FEMH-93-C-030
• Status: Suspended
• Phase: Phase 4
• First received: September 11, 2005
• Last updated: February 6, 2009
• Start date: January 2005
• Est. completion date: June 2007

Study information

• Verified date: June 2006
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether N-acetylcysteine is effective in the prophylaxis of post-cardiopulmonary bypass acute renal impairment.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardiopulmonary Bypass
• Cardiovascular Disease
• Cardiovascular Diseases
• Renal Insufficiency
• Renal Insufficiency, Acute

Intervention

Drug:
• N-Acetylcysteine 600mg/tab

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	Pan-Chiao	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital	Synmosa Biopharma Corp.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum creatinine and blood urea nitrogen: before, 48 h and 5 days after the operation procedure.