Clinical trial NCT01614951: The Pulmonary Protection Trial
Official title: Pulmonary Dysfunction After Open Heart Surgery: Randomized Clinical Trial With Focus on Lung-protective Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Lung Disease
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2012-06-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility 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

Primary outcomes:
measure: Oxygenation Index
timeFrame: From pre operation until 24 hours post operation
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen N
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Thoracic Surgery
name: Daniel A. Steinbrüchel, prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Risom EC, Buggeskov KB, Mogensen UB, Sundskard M, Mortensen J, Ravn HB. Preoperative pulmonary function in all comers for cardiac surgery predicts mortalitydagger. Interact Cardiovasc Thorac Surg. 2019 Aug 1;29(2):244-251. doi: 10.1093/icvts/ivz049. Epub 2019 Mar 15.
citation: Buggeskov KB, Sundskard MM, Jonassen T, Andersen LW, Secher NH, Ravn HB, Steinbruchel 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.
citation: Buggeskov KB, Jakobsen JC, Secher NH, Jonassen T, Andersen LW, Steinbruchel 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.
citation: Buggeskov KB, Wetterslev J, Secher NH, Andersen LW, Jonassen T, Steinbruchel 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.