NCT01186510

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 23, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

2.3 years

First QC Date

August 19, 2010

Last Update Submit

June 3, 2013

Conditions

Postoperative Pulmonary Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Inflammatory marker

    5 days

Study Arms (2)

Lung perfusion

EXPERIMENTAL
Procedure: lung perfusion

no lung perfusion

ACTIVE COMPARATOR
Procedure: no lung perfusion

Interventions

lung perfusionPROCEDURE

see literature of proceeding

Lung perfusion
no lung perfusionPROCEDURE

see literature of proceeding

no lung perfusion

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Emergency cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goethe University

Frankfurt am Main, 60590, Germany

Location

Related Publications (1)

  • Kiessling AH, Guo FW, Gokdemir Y, Thudt M, Reyher C, Scherer M, Beiras-Fernandez A, Moritz A. The influence of selective pulmonary perfusion on the inflammatory response and clinical outcome of patients with chronic obstructive pulmonary disease undergoing cardiopulmonary bypass. Interact Cardiovasc Thorac Surg. 2014 Jun;18(6):732-9. doi: 10.1093/icvts/ivu062. Epub 2014 Mar 14.

    PMID: 24632426DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Cardiovascular Research

Study Record Dates

First Submitted

August 19, 2010

First Posted

August 23, 2010

Study Start

August 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

DE(1)