Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol

Study Overview
=================
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).

Official Title
-----------------
A Prospective Randomized Double Blind Multicenter Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol

Conditions
-----------------
Aortic Valve Disease, Coronary Artery Disease (CAD)

Intervention / Treatment
-----------------
* Drug: Custodiol-N
* Drug: Custodiol


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Custodiol-N<br>comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery | Drug: Custodiol-N<br>* comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery<br>|
| Active Comparator: Custodiol<br>comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery | Drug: Custodiol<br>* comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catecholamine requirement on SICU |  | within 24 hours (cumulative dose) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aortic valve disease, coronary bypass surgery, cardioplegic solutions