Status:
COMPLETED
The RAS, Fibrinolysis and Cardiopulmonary Bypass
Lead Sponsor:
Vanderbilt University
Conditions:
Coronary Artery Disease
Angiotensin Converting Enzyme
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary bypass (CPB).1 CPB is associated with significant morbidity including hemodynamic instability, the transfu...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subjects, 18 to 80 years of age, scheduled for elective cardiac surgery requiring CPB
- For female subjects, the following conditions must be met:
- postmenopausal for at least 1 year, or status-post surgical sterilization, or if of childbearing potential, utilizing adequate birth control and willing to undergo urine beta-hcg testing prior to drug treatment and on every study day
Exclusion
- Left ventricle ejection fraction less than 30%
- History of ACE inhibitor-induced angioedema
- Hypotension (systolic blood pressure \<100 mmHg and evidence of hypoperfusion)
- Hyperkalemia (baseline potassium \>5.0 mEq/L)
- Inability to discontinue current ACE inhibitor or AT1 receptor antagonist.
- Emergency surgery
- Impaired renal function (serum creatinine \>1.6 mg/dl)
- Pregnancy
- Breast-feeding
- Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
- History of alcohol or drug abuse
- Treatment with any investigational drug in the 1 month preceding the study
- Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
- Inability to comply with the protocol, e.g. uncooperative attitude and unlikelihood of completing the study
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00607672
Start Date
August 1 2006
End Date
December 1 2011
Last Update
October 10 2012
Active Locations (2)
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1
TN Valley Healthcare System
Nashville, Tennessee, United States, 37212
2
Vanderbilt University
Nashville, Tennessee, United States, 37232