Lung Perfusion With Oxygenated Blood During Aortic Clamping

Postoperative Pulmonary Dysfunction Clinical Trial

— PulPer-001-Sch  

Official title:

Lung Perfusion With Oxygenated Blood During Aortic Clamping

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01186510
• Other study ID #: PulPer-001-Sch
• Status: Completed
• Phase: N/A
• First received: August 19, 2010
• Last updated: June 3, 2013
• Start date: August 2010
• Est. completion date: November 2012

Study information

• Verified date: June 2013
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18-80 ys

• Cardiopulmonary bypass procedure

• FEV1 <80%

• COPD >II

Exclusion Criteria:

• Emergency cases

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative Pulmonary Dysfunction

Intervention

Procedure:
• lung perfusion
see literature of proceeding
• no lung perfusion
see literature of proceeding

Locations

Country	Name	City	State
Germany	Goethe University	Frankfurt am Main

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory marker		5 days	No