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

NCT01444235 | Completed Phase 2 DMC

• 1 other identifier: CL-N-CSM-III/01/08
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Coronary Artery Disease (CAD)

Keywords

CAD, ACVB

Outcome Measures

Primary Outcomes (1)

• CK-MB area under the curve within 24 hours

  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

  Up to 24 hours after the aortic clamp release

Secondary Outcomes (3)

• Catecholamine requirement

  24 hours (cumulative dose)

• CK-MB peak

  Up to day 5

• Mortality any time during post-op through Day 30

  Up to Day 30

Study Arms (2)

Custodiol

ACTIVE COMPARATOR

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

Custodiol-N

EXPERIMENTAL

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

Interventions

Custodiol-N DRUG

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

Custodiol-N

Custodiol DRUG

Route of administration: by infusion duration: infusion technique will be continued for seven minutes dosage: until 1500-2000 mL of solution have been infused

Custodiol

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients \>/=35 and \</=80 years of age
• Male or female with 2 or 3 vessel coronary disease, who are scheduled for elective CBP surgery for coronary revascularisation
• 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.
• Eligibility for Swan-Ganz-Catheter
• Able to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study
• No evidence of severe organic or psychiatric disease by history or physical examination
• 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.

You may not qualify if:

• Patients undergoing valve repair or replacement
• History of recent (\< 6 weeks) Q-wave myocardial infarction
• Left ventricular ejection fraction \< 35% (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)
• Dialysis or creatinine \> 2 mmol/L
• BMS-Stent \< 4 weeks
• DES-Stent \< 6 month
• Guidance depended Plavix therapy

Sponsors & Collaborators

• Dr. F. Köhler Chemie GmbH: lead

Study Sites (4)

Klinik für Thorax- und Kardiovaskuläre Chirurgie, Universitätsklinikum Essen

Essen, 45147, Germany

Location

Abt. Herzchirugie, Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena

Jena, 07740, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Custodiol-N solution

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: September 30, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 17, 2013

Record last verified: 2013-05

Locations

DE (4)