The Pulmonary Protection Trial

Phase 4

Completed

• Conditions: Chronic Obstructive Lung Disease
• Interventions: Drug: HTK Custodiol; Other: Standard ECC; Procedure: Perfusion of the lungs

• Registration Number: NCT01614951
• Lead Sponsor: Rigshospitalet, Denmark

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-06
• Study First Submitted QC: 2012-06-07
• Study First Posted: 2012-06-08
• Study Start: 2012-07
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-24
• Last Update Posted: 2014-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulmoplegia	HTK Custodiol	-
Control group	Standard ECC	-
Pulmonary perfusion	Perfusion of the lungs	-

Primary Outcome Measures

Name	Time	Method
Oxygenation Index	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).

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen N, Denmark