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The Pulmonary Protection Trial

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ClinicalTrials.gov Identifier: NCT01614951
Recruitment Status : Completed
First Posted : June 8, 2012
Last Update Posted : April 25, 2014
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Daniel Steinbruchel, Rigshospitalet, Denmark

Study Description
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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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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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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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01614951


Locations
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Denmark
Rigshospitalet
Copenhagen N, Denmark, 2200
Sponsors and Collaborators
Rigshospitalet, Denmark
Lundbeck Foundation
Investigators
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Principal Investigator: Daniel A. Steinbrüchel, prof. Rigshospitalet, Thoracic Surgery
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Daniel Steinbruchel, Prof. dr. med., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01614951    
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    Key Record Dates
Last Update Posted: April 25, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases