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

NCT02098772 | Completed Phase 3

• 1 other identifier: CL-N-CSM-AV-III/05/12
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 6

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).

Conditions

Aortic Valve Disease; Coronary Artery Disease (CAD)

Keywords

aortic valve disease; coronary bypass surgery; cardioplegic solutions

Outcome Measures

Primary Outcomes (1)

• peak value for CK-MB

  measured at 4, 8, 12, 16, 20 and 24 hours after the release of the aortic cross clamp

Secondary Outcomes (1)

• Catecholamine requirement on SICU

  within 24 hours (cumulative dose)

Other Outcomes (1)

• Safety parameters

  from time of the study inclusion up to the follow-up visit on day 5

Study Arms (2)

Custodiol-N

EXPERIMENTAL

comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery

Drug: Custodiol-N

Custodiol

ACTIVE COMPARATOR

comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery

Drug: Custodiol

Interventions

Custodiol-N DRUG

comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery

Custodiol-N

Custodiol DRUG

comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery

Custodiol

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. F. Köhler Chemie GmbH: lead

Study Sites (6)

Klinik für Herzchirurgie, Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Klinik für Herz- und Gefäßchirurgie GmbH, Herz-Kreislauf-Zentrum Rotenburg

Rotenburg an der Fulda, Hesse, 36199, Germany

Location

Klinik für Herzchirurgie Universität Leipzig/ Herzzentrum Leipzig

Leipzig, Saxony, 04289, Germany

Location

Klinik für Herz- und Thoraxchirurgie Universitätsklinikum Jena

Jena, Thuringia, 07747, Germany

Location

Klinik für Thorax-, Herz- und Gefäßchirurgie, Uniklinik der RWTH Aachen

Aachen, 52074, Germany

Location

Klinik für Gefäßchirurgie, Universitäres Herzzentrum am UKE Hamburg

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Aortic Valve Disease; Coronary Artery Disease

Interventions

Custodiol-N solution

Condition Hierarchy (Ancestors)

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

Study Officials

• Gabor Szabó, Prof.

  Department of Cardiac Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: March 28, 2014
• Study Start: May 1, 2014
• Primary Completion: November 16, 2018
• Study Completion: December 1, 2018
• Last Updated: January 18, 2020

Record last verified: 2018-02

Locations

DE (6)