The Pulmonary Protection Trial

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	90 participants
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
Study Start Date :	July 2012
Actual Primary Completion Date :	November 2013
Actual Study Completion Date :	November 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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).

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 )
First Posted:	June 8, 2012
Last Update Posted:	April 25, 2014
Last Verified:	April 2014

Additional relevant MeSH terms:

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