Phase III Study Comparing Two Methods of Cardioplegia in Coronary Artery Bypass Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. F. Köhler Chemie GmbH
ClinicalTrials.gov Identifier:
NCT01444235
First received: September 29, 2011
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

Comparison of the cardioprotective effects and safety of two cardioplegic solutions (solutions used during a cardiac arrest in the heart surgery) in patients undergoing cardiopulmonary bypass for coronary artery bypass surgery.


Condition Intervention Phase
Coronary Artery Disease (CAD)
Drug: Custodiol-N
Drug: Custodiol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Double Blind Multicenter Phase III Study Comparing Two Methods of Cardioplegia in Coronary Artery Bypass Surgery Custodiol-N Versus Custodiol

Resource links provided by NLM:


Further study details as provided by Dr. F. Köhler Chemie GmbH:

Primary Outcome Measures:
  • CK-MB area under the curve within 24 hours [ Time Frame: Up to 24 hours after the aortic clamp release ] [ Designated as safety issue: Yes ]
    Measurements will be carried out at the following timepoints: 4,8,12,16,20,24 hours (± 30 min) after release of the aortic cross clamp


Secondary Outcome Measures:
  • Catecholamine requirement [ Time Frame: 24 hours (cumulative dose) ] [ Designated as safety issue: Yes ]
    Catecholamine requirement on surgical ICU within 24 hours

  • CK-MB peak [ Time Frame: Up to day 5 ] [ Designated as safety issue: Yes ]
    CK-MB peak on the days 2, 3, 4 and 5 after removal of aortic cross clamp

  • Mortality any time during post-op through Day 30 [ Time Frame: Up to Day 30 ] [ Designated as safety issue: Yes ]
    Mortality will be documented at any time during post-op through Day 30


Enrollment: 102
Study Start Date: March 2011
Study Completion Date: July 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Custodiol
After cross clamping of the aorta on cardiopulmonary bypass, the Custodiol solution, at a temperature of 4 - 6°C, will be infused antegrade into the root of the aorta.
Drug: Custodiol
Route of administration: by infusion duration: infusion technique will be continued for seven minutes dosage: until 1500-2000 mL of solution have been infused
Experimental: Custodiol-N
After cross clamping of the aorta on cardiopulmonary bypass, the Custodiol-N solution, at a temperature of 4 - 6°C, will be infused antegrade into the root of the aorta.
Drug: Custodiol-N
Route of administration: by infusion Dosage: will be infused antegrade into the root of the aorta until 1500-2000 mL of solution have been infused Duration: infusion technique will be continued for seven minutes

Detailed Description:

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 cardiopulmonary bypass for coronary artery bypass surgery. The study design is a prospective, double blind, multicenter, randomized, Phase III comparison study intended to demonstrate non-inferiority in surgical outcome between Custodiol and Custodiol-N as determined by CK-MB area under the curve (primary endpoint), catecholamine requirement(cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively (e.g., myocardial infarction).

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The study population will be selected from patients of either sex with coronary artery disease (CAD) who are to undergo cardiopulmonary bypass for coronary artery bypass surgery.

  1. Patients >/=35 and </=80 years of age
  2. Male or female with 2 or 3 vessel coronary disease, who are scheduled for elective CBP surgery for coronary revascularisation
  3. Presence of definite CAD for which surgical intervention is deemed necessary, without evidence of ongoing infarction.

    Patients with unstable angina can be included as long as there is no objective (negative cardiac isoenzymes in the immediate six hours preceding CABG, current intravenous use of nitrate therapy) or subjective (absence of prolonged symptoms suggestive of coronary insufficiency that do not respond to pharmacologic intervention) evidence of myocardial necrosis.

  4. Eligibility for Swan-Ganz-Catheter
  5. Able to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study
  6. No evidence of severe organic or psychiatric disease by history or physical examination
  7. No history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or no any history of drug abuse or addiction within 12 months of study enrollment.

Exclusion Criteria:

  1. Patients undergoing valve repair or replacement
  2. History of recent (< 6 weeks) Q-wave myocardial infarction
  3. Left ventricular ejection fraction < 35% (as assessed by any one of the following: contrast ventriculography, multigated acquisition scanning [MUGA], or 2-D ECHO)
  4. Patients on intra-aortic balloon devices or with history of previous coronary artery bypass surgery
  5. Pregnant or lactating patients
  6. Patients who have participated in any other investigational studies within 30 days previous to enrollment
  7. Patients in cardiogenic shock (defined as a systolic BP < 90 mmHg for over one hour despite inotropic and chronotropic support)
  8. Patients with severe chronic obstructive lung disease (FEV1 < 50%)
  9. Previous cardiac valvular disease (clinical relevant)
  10. Dialysis or creatinine > 2 mmol/L
  11. BMS-Stent < 4 weeks
  12. DES-Stent < 6 month
  13. Guidance depended Plavix therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444235

Locations
Germany
Klinik für Thorax- und Kardiovaskuläre Chirurgie, Universitätsklinikum Essen
Essen, Germany, 45147
Abt. Herzchirugie, Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena
Jena, Germany, 07740
Herzzentrum Leipzig GmbH
Leipzig, Germany, 04289
Sponsors and Collaborators
Dr. F. Köhler Chemie GmbH
Investigators
Principal Investigator: Gabor Szabo, Prof. Dr. Department of Cardiac Surgery of University of Heidelberg
Principal Investigator: Nikolaus Pizanis, Dr. Klinik für Thorax- und Kardiovaskuläre Chirurgie, Universitätsklinikum Essen
Principal Investigator: Florian Wagner, Dr. Klinik für Herz- und Gefäßchirurgie, Universitäts-Krankenhaus Eppendorf
Principal Investigator: Thorsten Doenst, Prof. Dr. Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena
Principal Investigator: Martin Misfeld, Dr. Herzzentrum Leipzig GmbH, Klinik für Herzchirurgie
  More Information

No publications provided

Responsible Party: Dr. F. Köhler Chemie GmbH
ClinicalTrials.gov Identifier: NCT01444235     History of Changes
Other Study ID Numbers: CL-N-CSM-III/01/08
Study First Received: September 29, 2011
Last Updated: May 16, 2013
Health Authority: Federal Institute for Drugs and Medical Devices(BfArM): Germany

Keywords provided by Dr. F. Köhler Chemie GmbH:
CAD, ACVB

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014