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The Pulmonary Protection Trial

Primary Purpose

Chronic Obstructive Lung Disease

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Perfusion of the lungs
HTK Custodiol
Standard ECC
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Obstructive Lung Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Planned and urgent surgery on legally competent patients over 18 years:

    • Coronary Artery Bypass Graft Surgery
    • Aortic Valve Replacement
    • Coronary Artery Bypass Graft Surgery + Aortic Valve Replacement
    • Transcatheter Aortic-Valve Implantation
  2. Spirometry FEV1 measurement show less than or equal to 80% of the anticipated. We expect that these patients provide the largest signal with lung protective interventions in relation to lung healthy patients.

Exclusion Criteria:

  • Previous surgery on the heart or lungs
  • Previous thoracic irradiation
  • Preoperative heart failure (ejection fraction below 20%).
  • Surgical demanding mitral regurgitation
  • Unstable patients (heart rate above 100 and systolic blood pressure below 100 mmHg)
  • Intubated patients
  • Patients with an ongoing preoperative treatment with antibiotics for suspected pneumonia.
  • Patients with renal insufficiency requiring hemodialysis
  • Pregnant and lactating

Sites / Locations

  • Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Pulmonary perfusion

Pulmoplegia

Control group

Arm Description

Outcomes

Primary Outcome Measures

Oxygenation Index
To investigate whether patients with a preoperative reduced pulmonary function have a better preserved oxygenation index after open heart surgery, using either pulmonary perfusion or pulmoplegia compared with TAVI and the control-group with standard ECC (Extra Corporal Circulation).

Secondary Outcome Measures

Full Information

First Posted
June 6, 2012
Last Updated
April 24, 2014
Sponsor
Rigshospitalet, Denmark
Collaborators
Lundbeck Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01614951
Brief Title
The Pulmonary Protection Trial
Official Title
Pulmonary Dysfunction After Open Heart Surgery: Randomized Clinical Trial With Focus on Lung-protective Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Lundbeck Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate whether patients with a preoperative reduced pulmonary function have a better preserved oxygenation capacity after open heart surgery, using either pulmonary perfusion or pulmoplegia compared with TAVI and the control-group with standard ECC (Extra Corporal Circulation).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Lung Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary perfusion
Arm Type
Experimental
Arm Title
Pulmoplegia
Arm Type
Experimental
Arm Title
Control group
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Perfusion of the lungs
Intervention Description
Pulmonary perfusion with oxygenated blood during ECC.
Intervention Type
Drug
Intervention Name(s)
HTK Custodiol
Intervention Description
Pulmoplegia before ECC.
Intervention Type
Other
Intervention Name(s)
Standard ECC
Intervention Description
ECC after standard procedure
Primary Outcome Measure Information:
Title
Oxygenation Index
Description
To investigate whether patients with a preoperative reduced pulmonary function have a better preserved oxygenation index after open heart surgery, using either pulmonary perfusion or pulmoplegia compared with TAVI and the control-group with standard ECC (Extra Corporal Circulation).
Time Frame
From pre operation until 24 hours post operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Planned and urgent surgery on legally competent patients over 18 years: Coronary Artery Bypass Graft Surgery Aortic Valve Replacement Coronary Artery Bypass Graft Surgery + Aortic Valve Replacement Transcatheter Aortic-Valve Implantation Spirometry FEV1 measurement show less than or equal to 80% of the anticipated. We expect that these patients provide the largest signal with lung protective interventions in relation to lung healthy patients. Exclusion Criteria: Previous surgery on the heart or lungs Previous thoracic irradiation Preoperative heart failure (ejection fraction below 20%). Surgical demanding mitral regurgitation Unstable patients (heart rate above 100 and systolic blood pressure below 100 mmHg) Intubated patients Patients with an ongoing preoperative treatment with antibiotics for suspected pneumonia. Patients with renal insufficiency requiring hemodialysis Pregnant and lactating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel A. Steinbrüchel, prof.
Organizational Affiliation
Rigshospitalet, Thoracic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen N
ZIP/Postal Code
2200
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
30879046
Citation
Risom EC, Buggeskov KB, Mogensen UB, Sundskard M, Mortensen J, Ravn HB. Preoperative pulmonary function in all comers for cardiac surgery predicts mortalitydagger. Interact Cardiovasc Thorac Surg. 2019 Aug 1;29(2):244-251. doi: 10.1093/icvts/ivz049. Epub 2019 Mar 15.
Results Reference
derived
PubMed Identifier
27651908
Citation
Buggeskov KB, Sundskard MM, Jonassen T, Andersen LW, Secher NH, Ravn HB, Steinbruchel DA, Jakobsen JC, Wetterslev J. Pulmonary artery perfusion versus no pulmonary perfusion during cardiopulmonary bypass in patients with COPD: a randomised clinical trial. BMJ Open Respir Res. 2016 Sep 6;3(1):e000146. doi: 10.1136/bmjresp-2016-000146. eCollection 2016.
Results Reference
derived
PubMed Identifier
25539792
Citation
Buggeskov KB, Jakobsen JC, Secher NH, Jonassen T, Andersen LW, Steinbruchel DA, Wetterslev J. Detailed statistical analysis plan for the pulmonary protection trial. Trials. 2014 Dec 23;15:510. doi: 10.1186/1745-6215-15-510.
Results Reference
derived
PubMed Identifier
23363494
Citation
Buggeskov KB, Wetterslev J, Secher NH, Andersen LW, Jonassen T, Steinbruchel DA. Pulmonary perfusion with oxygenated blood or custodiol HTK solution during cardiac surgery for postoperative pulmonary function in COPD patients: a trial protocol for the randomized, clinical, parallel group, assessor and data analyst blinded Pulmonary Protection Trial. Trials. 2013 Jan 31;14:30. doi: 10.1186/1745-6215-14-30.
Results Reference
derived

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The Pulmonary Protection Trial

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