The Pulmonary Protection Trial

This study has been completed.

Sponsor:

Collaborator:

Lundbeck Foundation

Information provided by (Responsible Party):

Daniel Steinbruchel, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT01614951

First received: June 6, 2012

Last updated: April 24, 2014

Last verified: April 2014

History of Changes

Purpose

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).

Condition	Intervention	Phase
Chronic Obstructive Lung Disease	Procedure: Perfusion of the lungs Drug: HTK Custodiol Other: Standard ECC	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention
Official Title:	Pulmonary Dysfunction After Open Heart Surgery: Randomized Clinical Trial With Focus on Lung-protective Interventions

Further study details as provided by Daniel Steinbruchel, Rigshospitalet, Denmark:

Primary Outcome Measures:

Oxygenation Index [ Time Frame: From pre operation until 24 hours post operation ]
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).


Enrollment:	90
Study Start Date:	July 2012
Study Completion Date:	November 2013
Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pulmonary perfusion	Procedure: Perfusion of the lungs Pulmonary perfusion with oxygenated blood during ECC.
Experimental: Pulmoplegia	Drug: HTK Custodiol Pulmoplegia before ECC.
Control group	Other: Standard ECC ECC after standard procedure

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

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: NCT01614951

Locations


Denmark
Rigshospitalet
Copenhagen N, Denmark, 2200

Sponsors and Collaborators

Rigshospitalet, Denmark

Lundbeck Foundation

Investigators


Principal Investigator:	Daniel A. Steinbrüchel, prof.	Rigshospitalet, Thoracic Surgery

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Buggeskov KB, Sundskard MM, Jonassen T, Andersen LW, Secher NH, Ravn HB, Steinbrüchel 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.

Buggeskov KB, Jakobsen JC, Secher NH, Jonassen T, Andersen LW, Steinbrüchel 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.

Buggeskov KB, Wetterslev J, Secher NH, Andersen LW, Jonassen T, Steinbrüchel 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.


Responsible Party:	Daniel Steinbruchel, Prof. dr. med., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT01614951 History of Changes
Other Study ID Numbers:	4141 2011-006290-25 ( EudraCT Number ) 4141 ( Other Identifier: EudraCT Protocol kode ) H-1-2012-0 24 ( Other Identifier: The Danish Scientific Ethical Committee protocol code ) 2007-58-0015. ( Other Identifier: The Danish Data Protection Agency journal number )
Study First Received:	June 6, 2012
Last Updated:	April 24, 2014

Additional relevant MeSH terms:


Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 21, 2017

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