The Pulmonary Protection Trial

Rigshospitalet

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Lung Disease

Treatments: Drug: HTK Custodiol; Procedure: Perfusion of the lungs; Other: Standard ECC

Study type: Interventional

Funder types: Other

Identifiers

NCT01614951

2011-006290-25 (EudraCT Number)

4141 (Other Identifier)

H-1-2012-0 24 (Other Identifier)

2007-58-0015. (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Pulmonary perfusion

Experimental group

Treatment:

Procedure: Perfusion of the lungs

Pulmoplegia

Experimental group

Treatment:

Drug: HTK Custodiol

Control group

Other group

Treatment:

Other: Standard ECC