Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00190034
• Date of registration: 11/09/2005
• Prospective Registration: No
• Primary sponsor: Far Eastern Memorial Hospital
• Public title: Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.
• Scientific title: N-Acetylcysteine Protects Against Acute Renal Insult in Patients With Abnormal Renal Function Undergoing Cardiopulmonary Bypass.
• Date of first enrolment: January 2005
• Target sample size: 60
• Recruitment status: Suspended
• URL: http://clinicaltrials.gov/show/NCT00190034
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
• Phase: Phase 4

Countries of recruitment

Taiwan

Contacts

• Name: Shao-jung Li, M.D.
• Affiliation: Far Eastern Memorial Hospital

Key inclusion & exclusion criteria

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



Age minimum: 16 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cardiopulmonary Bypass

Renal Insufficiency, Acute

Cardiovascular Disease

Intervention(s)

Drug: N-Acetylcysteine 600mg/tab

Primary Outcome(s)

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

Secondary ID(s)

FEMH-93-C-030

FEMH-93010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

SYNMOSA BIOPHARMA