ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02098772
Recruitment Status : Recruiting
First Posted : March 28, 2014
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. F. Köhler Chemie GmbH

February 14, 2014
March 28, 2014
February 21, 2018
May 2014
July 2018   (Final data collection date for primary outcome measure)
peak value for CK-MB [ Time Frame: measured at 4, 8, 12, 16, 20 and 24 hours after the release of the aortic cross clamp ]
Same as current
Complete list of historical versions of study NCT02098772 on ClinicalTrials.gov Archive Site
Catecholamine requirement on SICU [ Time Frame: within 24 hours (cumulative dose) ]
Same as current
Safety [ Time Frame: from time of the study inclusion up to the follow-up visit on day 5 ]
documentation and reporting of AE and SAE
Same as current
 
Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
A Prospective Randomized Double Blind Multicenter Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus 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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Aortic Valve Disease
  • Coronary Artery Disease (CAD)
  • Drug: Custodiol-N
    comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery
  • Drug: Custodiol
    comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery
  • Experimental: Custodiol-N
    comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery
    Intervention: Drug: Custodiol-N
  • Active Comparator: Custodiol
    comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery
    Intervention: Drug: Custodiol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
530
437
December 2018
July 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
30 Years to 85 Years   (Adult, Older Adult)
No
Germany
 
 
NCT02098772
CL-N-CSM-AV-III/05/12
No
Not Provided
Not Provided
Dr. F. Köhler Chemie GmbH
Dr. F. Köhler Chemie GmbH
Not Provided
Principal Investigator: Gabor Szabó, Prof. Department of Cardiac Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg
Dr. F. Köhler Chemie GmbH
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP