Aortic Valve Disease, Coronary Artery Disease (CAD)
Conditions
Keywords
aortic valve disease, coronary bypass surgery, cardioplegic solutions
Brief summary
The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients undergoing aortic valve surgery. The study design is a prospective, double blind, multicenter, randomized, Phase III comparison study intended to demonstrate superiority in surgical outcome between Custodiol and Custodiol-N as determined by CK-MB peak value 4-24 hours after opening of the aortic cross-clamp (primary endpoint), catecholamine requirement (cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively (e.g., myocardial infarction).
Interventions
DRUGCustodiol-N
comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery
DRUGCustodiol
comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery
Sponsors
Dr. F. Köhler Chemie GmbH
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients \>/= 30 and \</= 85 years of age * Male or female with aortic valve disease * Able to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study * Women of childbearing potential (ie, those who have not undergone a hysterectomy or who have not been post-menopausal for at least 12 consecutive months) must test negative for pregnancy prior to bypass surgery.
Exclusion criteria
* History of recent (\< 6 weeks) Q-wave myocardial infarction * Left ventricular ejection fraction \< 25% (as assessed by any one of the following: contrast ventriculography, multigated acquisition scanning \[MUGA\], or 2-D ECHO) * Patients on intra-aortic balloon devices or with history of previous coronary artery bypass surgery * Pregnant or lactating patients * Patients who have participated in any other investigational studies within 30 days previous to enrollment * Patients in cardiogenic shock (defined as a systolic BP \< 90 mmHg for over one hour despite inotropic and chronotropic support) * Patients with severe chronic obstructive lung disease (FEV1 \< 50%) * Previous cardiac valvular disease (clinical relevant) * GFR \<60 ml/min * Planned Ross-procedure, Mitral valve surgery, Aortic valve reconstruction, double valve surgery, other concomitant operations excluding coronary artery bypass surgery or closing a patent foramen ovale * Evidence of severe organic (e.g. cirrhosis of the liver) or psychiatric disease by history or physical examination * History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| peak value for CK-MB | measured at 4, 8, 12, 16, 20 and 24 hours after the release of the aortic cross clamp |
Secondary
| Measure | Time frame |
|---|---|
| Catecholamine requirement on SICU | within 24 hours (cumulative dose) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety parameters | from time of the study inclusion up to the follow-up visit on day 5 | documentation and reporting of AE and SAE |
Countries
Germany
Outcome results
None listed