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NCT00607672 · ClinicalTrials.gov registry record · Phase 4
The RAS, Fibrinolysis and Cardiopulmonary Bypass
A Phase 4 study, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 4
- Development phase
- 111
- Enrollment target
NCT00607672 is a Phase 4 study that has completed, run by Vanderbilt University. The registered enrollment target is 111 participants.
The verdict
NCT00607672, a Phase 4 study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 111 participants
- Enrollment target
Study 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 transfusion of allogenic blood products, and inflammation. Blood product transfusion increases mortality after cardiac surgery. Enhanced fibrinolysis contributes to increased blood product transfusion requirements in the perioperative period. CPB activates the kallikrein-kinin system (KKS), leading to increased bradykinin concentrations. Bradykinin, acting through its B2 receptor, stimulates the release of nitric oxide, inflammatory cytokines and tissue-type plasminogen activator (t-PA). Based on data indicating that angiotensin-converting enzyme (ACE) inhibitors reduce mortality in patients with coronary artery disease, many patients undergoing CPB are taking ACE inhibitors. While interruption of the renin-angiotensin system (RAS) reduces inflammation in response to CPB, ACE inhibitors also potentiate the effects of bradykinin and may augment B2-mediated change in fibrinolytic balance and inflammation. In contrast, angiotensin II type 1 receptor antagonism does not potentiate bradykinin and does not inhibit bradykinin metabolism. Studies in animals suggest that bradykinin receptor antagonism inhibits reperfusion-induced increases in vascular permeability and neutrophil recruitment.A randomized, placebo controlled clinical trial of a bradykinin B2 receptor antagonist demonstrated some effect on survival in patients with systemic inflammatory response syndrome and gram-negative sepsis. In addition, we and others have shown bradykinin B2 receptor antagonism reduces vascular t-PA release during ACE inhibition. The current proposal derives from data from our laboratory and others elucidating the role of the KKS in the inflammatory, hypotensive and fibrinolytic response to CPB. Specifically, we have found that CPB activates the KKS and that ACE inhibition and smoking further incre
Interventions
- DRUG Placebo
- DRUG Ramipril
- DRUG Candesartan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2006-08 |
| Est. Completion | 2011-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00607672
The ClinicalTrials.gov registry entry for NCT00607672 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00607672 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00607672 about?
NCT00607672 is a clinical study titled "The RAS, Fibrinolysis and Cardiopulmonary Bypass". 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 transfusion of allogenic blood products, and inflammation. Blood product transfusion increases mortality af...
What is the current status of trial NCT00607672?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 111 participants. The study started on 2006-08. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00607672?
The interventions under investigation include: Placebo (DRUG), Ramipril (DRUG), Candesartan (DRUG).
Who is sponsoring clinical trial NCT00607672?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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