Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
- Conditions
- Aortic Valve DiseaseCoronary Artery Disease (CAD)
- Interventions
- Drug: Custodiol-NDrug: Custodiol
- Registration Number
- NCT02098772
- Lead Sponsor
- Dr. F. Köhler Chemie GmbH
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 530
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Custodiol-N Custodiol-N comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery Custodiol Custodiol comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery
- Primary Outcome Measures
Name Time Method 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
Name Time Method Catecholamine requirement on SICU within 24 hours (cumulative dose)
Trial Locations
- Locations (6)
Klinik für Herz- und Thoraxchirurgie Universitätsklinikum Jena
🇩🇪Jena, Thüringen, Germany
Klinik für Herzchirurgie, Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Baden-Württemberg, Germany
Klinik für Herz- und Gefäßchirurgie GmbH, Herz-Kreislauf-Zentrum Rotenburg
🇩🇪Rotenburg an der Fulda, Hessen, Germany
Klinik für Gefäßchirurgie, Universitäres Herzzentrum am UKE Hamburg
🇩🇪Hamburg, Germany
Klinik für Herzchirurgie Universität Leipzig/ Herzzentrum Leipzig
🇩🇪Leipzig, Sachsen, Germany
Klinik für Thorax-, Herz- und Gefäßchirurgie, Uniklinik der RWTH Aachen
🇩🇪Aachen, Germany