- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01436981
Pharmacokinetics of Pavaverine After Intraluminal Administration
June 3, 2013 updated by: Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospital
Observational Study on Papaverine During Cardiac Surgical Procedures
The purpose of this study is to determine the pharmacokinetic of papaverine after administration into the artery mammaria interna.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
12
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hessen
-
Frankfurt am Main, Hessen, Germany, 60590
- Klinikum der Goethe Universität Frankfurt
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
CABG patients
Description
Inclusion Criteria:
- CABG
- Administration of papaverine into mammaria interna
Exclusion Criteria:
- Allergy against papaverine
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CABG with papaverine
Patients with CABG procedure
|
Preparation of artery mammaria interna
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum plasma concentration of papaverine
Time Frame: 4 hours
|
Serum probes will be analysed for the concentrations of papaverine.
|
4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Arndt H Kiessling, MD, Johann Wolfgang Goethe University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
September 14, 2011
First Submitted That Met QC Criteria
September 19, 2011
First Posted (Estimate)
September 20, 2011
Study Record Updates
Last Update Posted (Estimate)
June 4, 2013
Last Update Submitted That Met QC Criteria
June 3, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PAV002-AHK
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Complications Due to Coronary Artery Bypass Graft
-
Centre hospitalier de l'Université de Montréal...Centre de Recherche du Centre Hospitalier de l'Université de MontréalUnknownGraft Failure | Complications Due to Coronary Artery Bypass GraftCanada
-
The Royal Wolverhampton Hospitals NHS TrustMaquet CardiovascularCompletedComplications Due to Coronary Artery Bypass GraftUnited Kingdom
-
Riphah International UniversityCompletedComplications Due to Coronary Artery Bypass GraftPakistan
-
Universidade Federal de Santa MariaCompletedComplications Due to Coronary Artery Bypass GraftBrazil
-
Rigshospitalet, DenmarkCompletedMyocardial Ischemia | Heart Diseases | Cardiovascular Diseases | Vascular Diseases | Coronary Artery Disease | Coronary Disease | Arteriosclerosis | Arterial Occlusive Diseases | Complications Due to Coronary Artery Bypass GraftDenmark
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São Paulo; InCor Heart InstituteCompletedLeukocyte Disorders | Systemic Inflammatory Response Syndrome (SIRS) | Complications Due to Coronary Artery Bypass Graft
-
Riphah International UniversityCompleted
-
Loma Linda UniversityEdwards LifesciencesCompletedCoronary Artery Bypass GraftUnited States
-
Montreal Heart InstituteCompletedCoronary Artery Bypass GraftCanada
-
South Valley UniversityActive, not recruitingCoronary Artery Bypass Graft SurgeryEgypt
Clinical Trials on CABG
-
Assiut UniversityRecruitingCAD - Coronary Artery DiseaseEgypt
-
Kuopio University HospitalTerminatedCoronary Artery Disease | Paroxysmal Atrial FibrillationFinland
-
St. Petersburg State Pavlov Medical UniversityRecruitingIschemic Heart Disease | Valve Heart Disease | Cardiac Procedure Complication | Defect SeptalRussian Federation
-
St. Petersburg State Pavlov Medical UniversityCompletedCoronary Artery Disease | CABG | Ischemic Heart Disease | Ischemic Reperfusion InjuryRussian Federation
-
Peking University Third HospitalNot yet recruitingMinimally Invasive Cardiac Surgery
-
University of AarhusUnknown
-
Chinese Academy of SciencesThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical...CompletedChronic Ischemic CardiomyopathyChina
-
St. Petersburg State Pavlov Medical UniversityRecruitingIschemic Heart Disease | Coronary Artery Bypass GraftingRussian Federation
-
Imperial College LondonUniversity Hospitals, Leicester; Medical University of Silesia; Royal Brompton... and other collaboratorsCompletedCoronary Artery Disease | Mitral RegurgitationUnited Kingdom, Poland
-
Diagram B.V.RecruitingCoronary Artery DiseaseBelgium, Poland, Slovakia