Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
A randomised controlled trial will be performed to evaluate the effects of lung volume reduction surgery (LVRS) in patients with COPD on systemic inflammation, oxidative stress, endothelial function, arterial stiffness and blood pressure. We hypothesize that LVRS will lead to a reduction of systemic inflammation, oxidative stress, arterial stiffness and blood pressure and to improved endothelial function. For this purpose 30 patients with severe/very severe COPD (GOLD III-IV) and pulmonary emphysema who are to undergo LVRS will be randomised to one of two groups: group 1 receiving immediate LVRS and group 2 receiving LVRS after a delay of 3 months. Measures of systemic inflammation, oxidative stress, endothelial function, arterial stiffness and blood pressure will be measured at baseline and 3 months after surgery and no surgery, respectively (group 2 receiving surgery only after a delay of 3 months will serve as control group) to investigate the effects of LVRS on the described outcomes.
Detailed description
Not desired
Interventions
PROCEDURELung volume reduction surgery
Lung volume reduction surgery
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Dyspnea at rest or at minimal physical activity, severe limitation of exercise capacity (6-min walk distance \< 350 m). * Acceptance of an increased perioperative mortality (approximately 2 %) and/or morbidity (long lasting hospitalization due to prolonged air leaks) * COPD (GOLD guidelines) with severe obstructive ventilatory defect (FEV1 \<35% predicted) * Functional aspects of lung emphysema, i.e. irreversible hyperinflation with a residual volume to total lung capacity ratio (RV/TLC) of \>0.65 and an impaired total lung diffusion capacity (DLCO), usually \< 40% predicted. * Pulmonary emphysema confirmed by high resolution computer tomography
Exclusion criteria
- Current smokers * Age \> 75years * Vanishing lung or diffuse lung emphysema on CT, FEV1 \<20% predicted and DLCO \<20% predicted, and hypercapnia (PaCO2 \>7.3kPa) * Overt active coronary artery disease, severe left ventricular function impairment * Pulmonary hypertension with a mean pulmonary artery pressure \>35 mmHg at rest * Acute bronchopulmonary infection, bronchiectasis on high resolution tomography * Pulmonary cachexia (body mass index \<18kg/m2) * Neoplastic disease with a life expectancy of less than 2 years * Addiction to alcohol/drugs * Relevant renal (creatinine \>150ug/ml), active gastroenterological (GI-bleeding in the previous year, abnormal liver function, active inflammatory bowel disease) or active neurological disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Systemic inflammation 2. Vascular function | Before and 3 months after surgery/no surgery |
Secondary
| Measure | Time frame |
|---|---|
| 1. Oxidative stress 2. Blood pressure 3. Physical Activity 4. Lung function 5. Hypoxemia | Before and 3 months after surgery/no surgery |
Countries
Switzerland
Outcome results
None listed