The Pulmonary Protection Trial

Chronic Obstructive Lung Disease Clinical Trial

Official title:

Pulmonary Dysfunction After Open Heart Surgery: Randomized Clinical Trial With Focus on Lung-protective Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01614951
• Other study ID #: 4141
• Secondary ID: 2011-006290-2541
• Status: Completed
• Phase: Phase 4
• First received: June 6, 2012
• Last updated: April 24, 2014
• Start date: July 2012
• Est. completion date: November 2013

Study information

• Verified date: April 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Obstructive Lung Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Perfusion of the lungs
Pulmonary perfusion with oxygenated blood during ECC.

Drug:
• HTK Custodiol
Pulmoplegia before ECC.

Other:
• Standard ECC
ECC after standard procedure

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen N

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygenation Index	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).	From pre operation until 24 hours post operation	No