Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.

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

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

Study Overview

• Status: Suspended
• Conditions: Cardiovascular Disease; Cardiopulmonary Bypass; Renal Insufficiency, Acute
• Intervention / Treatment: Drug: N-Acetylcysteine 600mg/tab

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei
    • Pan-Chiao, Taipei, Taiwan, 220
      • Far Eastern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Serum creatinine and blood urea nitrogen: before, 48 h and 5 days after the operation procedure.

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital
• Collaborators: Synmosa Biopharma Corp.
• Investigators: Study Chair: Shao-jung Li, M.D., Far Eastern Memorial Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Study Completion (Anticipated): June 1, 2007

Study Registration Dates

• First Submitted: September 11, 2005
• First Submitted That Met QC Criteria: September 11, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Estimate): February 9, 2009
• Last Update Submitted That Met QC Criteria: February 6, 2009
• Last Verified: June 1, 2006

More Information

Terms related to this study

• Keywords: cardiac surgery; cardiopulmonary bypass; acute renal insufficiency; Acetylcysteine
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Cardiovascular Diseases; Renal Insufficiency; Acute Kidney Injury; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Protective Agents; Respiratory System Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine
• Other Study ID Numbers: FEMH-93010; FEMH-93-C-030