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: November 18, 2013
Last verified: November 2013
  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

Resource links provided by NLM:


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
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
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

No publications provided by Rigshospitalet, Denmark

Additional 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: November 18, 2013
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 April 17, 2014