Pulmonary dysfunction after open heart surgery: Clinical trial with focus on protecting of the lungs

Phase 1

• Conditions: Dysfunction of the lungs after open heart surgery.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2011-006290-25-DK
• Lead Sponsor: Copenhagen University Hospital Rigshospitalet, The Heart Center - Department of Thoracic Surgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-02
• Last Update Posted: 16 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

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 clinical trial of medicinal product
• Study Design: Not specified