A Prospective Randomized Double Blind Multicenter Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
| Registry | NCT02098772, acronym Custodiol-AV |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional; randomized, factorial, masking: double, treatment |
| Enrollment | 530 (Actual) |
| Sponsor | Dr. F. Köhler Chemie GmbH (Industry) |
| Conditions | Aortic Valve Disease, Coronary Artery Disease (CAD) |
| Interventions | Custodiol-N, Custodiol (Drug) |
| Dates | start 2014-05-01, primary completion 2018-11-16, completion 2018-12-01, first posted 2014-03-28, last updated 2020-01-18 |
| Locations | 6 sites in Germany |
Related Papers Related Patents Related Grants Related Experts
All trials for Aortic Valve Disease All trials for Coronary Artery Disease (CAD) All trials of Custodiol-N All trials of Custodiol
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Custodiol-N | Experimental | Drug: Custodiol-N | comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery |
| Custodiol | Active comparator | Drug: Custodiol | comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery |
Sex: All, ages: 30 Years to 85 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Klinik für Herzchirurgie, Universitätsklinikum Heidelberg | Heidelberg, Baden-Wurttemberg | Germany | |
| Klinik für Herz- und Gefäßchirurgie GmbH, Herz-Kreislauf-Zentrum Rotenburg | Rotenburg an der Fulda, Hesse | Germany | |
| Klinik für Herzchirurgie Universität Leipzig/ Herzzentrum Leipzig | Leipzig, Saxony | Germany | |
| Klinik für Herz- und Thoraxchirurgie Universitätsklinikum Jena | Jena, Thuringia | Germany | |
| Klinik für Thorax-, Herz- und Gefäßchirurgie, Uniklinik der RWTH Aachen | Aachen | Germany | |
| Klinik für Gefäßchirurgie, Universitäres Herzzentrum am UKE Hamburg | Hamburg | Germany |