Pharmacokinetics of Pavaverine After Intraluminal Administration

This study has been completed.
Sponsor:
Collaborator:
Klinikum Ludwigshafen
Information provided by (Responsible Party):
Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01436981
First received: September 14, 2011
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to determine the pharmacokinetic of papaverine after administration into the artery mammaria interna.


Condition Intervention
Injury of Internal Mammary Artery
Complications Due to Coronary Artery Bypass Graft
Procedure: CABG

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study on Papaverine During Cardiac Surgical Procedures

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Maximum plasma concentration of papaverine [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    Serum probes will be analysed for the concentrations of papaverine.


Enrollment: 12
Study Start Date: October 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CABG with papaverine
Patients with CABG procedure
Procedure: CABG
Preparation of artery mammaria interna
Other Name: Paveron N

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

CABG patients

Criteria

Inclusion Criteria:

  • CABG
  • Administration of papaverine into mammaria interna

Exclusion Criteria:

  • Allergy against papaverine
  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: NCT01436981

Locations
Germany
Klinikum der Goethe Universität Frankfurt
Frankfurt am Main, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Klinikum Ludwigshafen
Investigators
Principal Investigator: Arndt H Kiessling, MD Johann Wolfgang Goethe University Hospitals
  More Information

No publications provided

Responsible Party: Arndt-H. Kiessling, Head cardiovascular research, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01436981     History of Changes
Other Study ID Numbers: PAV002-AHK
Study First Received: September 14, 2011
Last Updated: June 3, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
papaverine
pharmacokinetic
CABG
Injury of Internal Mammary Artery
Complications Due to Coronary Artery Bypass Graft

Additional relevant MeSH terms:
Papaverine
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on September 16, 2014