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
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: 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 September 18, 2014