The Pulmonary Protection Trial (PP-Trial)Pulmonary dysfunction after open heart surgery: Randomized clinical trial with focus on lung-protective interventions - The Pulmonary Protection Trial (PP-Trial)

Copenhagen University Hospital Rigshospitalet, The Heart Center - Department of Thoracic Surgery0 sites120 target enrollmentMay 2, 2012

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Dysfunction of the lungs after open heart surgery.
Sponsor: Copenhagen University Hospital Rigshospitalet, The Heart Center - Department of Thoracic Surgery
Enrollment: 120
Status: Active, not recruiting
Last Updated: 9 years ago

No summary available.

Registry

who.int

Start Date

May 2, 2012

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Copenhagen University Hospital Rigshospitalet, The Heart Center - Department of Thoracic Surgery

•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 40

•\- 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