Lung Perfusion With Oxygenated Blood During Aortic Clamping (PulPer-001-Sch)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01186510
First received: August 19, 2010
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

Pulmonary dysfunction presumably linked to an inflammatory response is frequent after cardiac operations using cardiopulmonary bypass (CPB) and pulmonary hypoperfusion.

Aim of the study: To evaluate the protective effect of continuous pulmonary perfusion with oxygenated blood during aortic crossclamping on the inflammatory response.


Condition Intervention
Postoperative Pulmonary Dysfunction
Procedure: lung perfusion
Procedure: no lung perfusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lung Perfusion With Oxygenated Blood During Aortic Clamping

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

Primary Outcome Measures:
  • Inflammatory marker [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: August 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lung perfusion Procedure: lung perfusion
see literature of proceeding
Active Comparator: no lung perfusion Procedure: no lung perfusion
see literature of proceeding

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-80 ys
  • Cardiopulmonary bypass procedure
  • FEV1 <80%
  • COPD >II

Exclusion Criteria:

  • Emergency cases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186510

Locations
Germany
Goethe University
Frankfurt am Main, Germany, 60590
Sponsors and Collaborators
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: NCT01186510     History of Changes
Other Study ID Numbers: PulPer-001-Sch
Study First Received: August 19, 2010
Last Updated: June 3, 2013
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on April 17, 2014