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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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Oxygenation Index [ Time Frame: From pre operation until 24 hours post operation ] [ Designated as safety issue: No ]
    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)
Genders Eligible for Study:   Both
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
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):

Responsible Party: Daniel Steinbruchel, Prof. dr. med., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01614951     History of Changes
Other Study ID Numbers: 4141  2011-006290-25  4141  H-1-2012-0 24  2007-58-0015. 
Study First Received: June 6, 2012
Last Updated: April 24, 2014
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 28, 2016