Clinical trial NCT02098772: Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Aortic Valve Disease
Coronary Artery Disease (CAD)
Keywords: aortic valve disease
coronary bypass surgery
cardioplegic solutions
Lead sponsor: Dr. F. Köhler Chemie GmbH
Sponsor class: INDUSTRY
First posted: 2014-03-28
Enrollment: 530
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: peak value for CK-MB
timeFrame: measured at 4, 8, 12, 16, 20 and 24 hours after the release of the aortic cross clamp
Secondary outcomes:
measure: Catecholamine requirement on SICU
timeFrame: within 24 hours (cumulative dose)
Other outcomes:
measure: Safety parameters
timeFrame: from time of the study inclusion up to the follow-up visit on day 5
Locations:
city: Heidelberg
country: Germany
facility: Klinik für Herzchirurgie, Universitätsklinikum Heidelberg
state: Baden-Württemberg
city: Rotenburg an der Fulda
country: Germany
facility: Klinik für Herz- und Gefäßchirurgie GmbH, Herz-Kreislauf-Zentrum Rotenburg
state: Hessen
city: Leipzig
country: Germany
facility: Klinik für Herzchirurgie Universität Leipzig/ Herzzentrum Leipzig
state: Sachsen
city: Jena
country: Germany
facility: Klinik für Herz- und Thoraxchirurgie Universitätsklinikum Jena
state: Thüringen
city: Aachen
country: Germany
facility: Klinik für Thorax-, Herz- und Gefäßchirurgie, Uniklinik der RWTH Aachen
city: Hamburg
country: Germany
facility: Klinik für Gefäßchirurgie, Universitäres Herzzentrum am UKE Hamburg
Study officials:
affiliation: Department of Cardiac Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg
name: Gabor Szabó, Prof.
role: PRINCIPAL_INVESTIGATOR
References: