Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
Information source: Dr. F. Köhler Chemie GmbH
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Aortic Valve Disease; Coronary Artery Disease (CAD)
Intervention: Custodiol-N (Drug); Custodiol (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Dr. F. Köhler Chemie GmbH Official(s) and/or principal investigator(s): Gabor Szabó, Prof., Principal Investigator, Affiliation: Department of Cardiac Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg
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).
Clinical Details
Official title: A Prospective Randomized Double Blind Multicenter Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: peak value for CK-MB
Secondary outcome: Catecholamine requirement on SICU
Eligibility
Minimum age: 30 Years.
Maximum age: 85 Years.
Gender(s): Both.
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.
Locations and Contacts
Klinik für Thorax-, Herz- und Gefäßchirurgie, Uniklinik der RWTH Aachen, Aachen 52074, Germany; Recruiting Rüdiger Autschbach, Prof. Dr. med., Phone: 0241, Ext: 8089221, Email: rautschbach@ukaachen.de Andreas Goetzenich, PD Dr. med., Phone: 0241, Ext: 8035556, Email: agoetzenich@ukaachen.de
Klinik für Gefäßchirurgie, Universitäres Herzzentrum am UKE Hamburg, Hamburg 20246, Germany; Recruiting Florian Wagner, Dr. med., Phone: +49 40 74105 8949, Email: fl.wagner@uke.de Johannes Schirmer, Dr. med. Florian Wagner, Dr. med., Principal Investigator Johannes Schirmer, Dr. med., Sub-Investigator
Klinik für Herzchirurgie, Universitätsklinikum Heidelberg, Heidelberg, Baden-Württemberg 69120, Germany; Recruiting Gabor Szabo, Prof. Dr. med., Phone: +49 6221 566 111, Email: Gabor.Szabo@urz.uni-heidelberg.de Gabor Veres, Dr. med., Phone: +49 6221 56 36126 Gabor Szabo, Prof. Dr. med., Principal Investigator Alexander Weymann, Dr. med., Sub-Investigator Gabor Veres, Dr. med., Sub-Investigator
Klinik für Herz- und Gefäßchirurgie GmbH, Herz-Kreislauf-Zentrum Rotenburg, Rotenburg an der Fulda, Hessen 36199, Germany; Active, not recruiting
Klinik für Herzchirurgie Universität Leipzig/ Herzzentrum Leipzig, Leipzig, Sachsen 04289, Germany; Recruiting Martin Misfeld, Prof. Dr. med., Phone: +49 341 865 0, Email: Martin.Misfeld@herzzentrum-leipzig.de Piroze Davierwala, Dr. med., Phone: +49 341 865 251 049 Martin Misfeld, Prof. Dr. med., Principal Investigator Piroze Davierwala, D. med., Sub-Investigator
Klinik für Herz- und Thoraxchirurgie Universitätsklinikum Jena, Jena, Thüringen 07747, Germany; Recruiting Thorsten Doenst, Prof. Dr. med, Phone: +49 3641 932 2901, Email: doenst@med.uni-jena.de Paulo Amorim, Dr., Phone: +49 3641 932 2948, Email: Paulo.amorim@med.uni-jena.de Thorsten Doenst, Prof. Dr. med., Principal Investigator Paulo Amorim, Dr. med., Sub-Investigator Tim Sandhaus, Dr. med., Sub-Investigator
Additional Information
Starting date: May 2014
Last updated: February 20, 2015
|