Influence of effective noninvasive positive pressure ventilation on biomarkers in stable hypercapnic COPD patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00007644

Enrollment

Registered

2015-01-23

Start date

2010-11-08

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J44.9

Interventions

Group 1: Comparison of blood gas analysis and systemic inflammation parameters in COPD patients, in whom NPPV will be initiated

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: COPD patients in stadium GOLD iV with hypercapnia (PaCO2 > 50 mmHg) Stable state of disease (pH >7,33)

Exclusion criteria

Exclusion criteria: • Severe Obesity (BMI > 35 kg/m2) • Restrictive lung disease (total lung capacity <80%) • Acute infections including acute pulmonary exacerbation • Chronic inflammatory diseases other than COPD or atherosclerosis that could be potential confounders (e.g. rheumatic disease, collagenoses, etc.) • Malignant disease • Anti-inflammatory or immunosuppressive drugs other than statins, aspirin or clopidogrel

Design outcomes

Primary

Measure	Time frame
Nocturnal PaCO2 measured at 4 a.m. before and after initiation of noninvasive ventilation	—

Secondary

Measure	Time frame
Sleep lab / Dep. Of Pneumology: • lung function parameters (body plethysmogrpahy) during daytime at study inclusion and 3 months after study inclusion • blood gases (pH, PaO2, PaCO2, HCO3-) during daytime at study inclusion, under NIV at study inclusion and during daytime 3 months after study inclusion and under NIV 3 months after study inclusion • health related quality of life (SRI) at study inclusion and 3 months after study inclusion • compliance (ventilator hours) 3 months after study inclusion Experimental lab: at study inclusion and 3 months after study inclusion • Plasma: i) IL1ß, IL-6, IL-8, MCP-1, TNFa, IL-10, IL-12 by cytokine bead array ii) PAI-1, IL-18, sCD40L by ELISA • RNA: TRAFs 1-7 by qPCR • FACS: CD3, CD4, CD8 T cells, Tregs, patrolling and inflammatory monocyte subtypes (CD14/CD16), B cells (CD20), oxidative stress by kit. Routine laboratory: at study inclusion and 3 months after study inclusion • Diff BB, Na, K, Urea, Creatinine, proBNP, hsTnT, Lipidelpho, CRP, HbA1c, hsCRP	—

Measure

Time frame

Sleep lab / Dep. Of Pneumology: • lung function parameters (body plethysmogrpahy) during daytime at study inclusion and 3 months after study inclusion • blood gases (pH, PaO2, PaCO2, HCO3-) during daytime at study inclusion, under NIV at study inclusion and during daytime 3 months after study inclusion and under NIV 3 months after study inclusion • health related quality of life (SRI) at study inclusion and 3 months after study inclusion • compliance (ventilator hours) 3 months after study inclusion Experimental lab: at study inclusion and 3 months after study inclusion • Plasma: i) IL1ß, IL-6, IL-8, MCP-1, TNFa, IL-10, IL-12 by cytokine bead array ii) PAI-1, IL-18, sCD40L by ELISA • RNA: TRAFs 1-7 by qPCR • FACS: CD3, CD4, CD8 T cells, Tregs, patrolling and inflammatory monocyte subtypes (CD14/CD16), B cells (CD20), oxidative stress by kit. Routine laboratory: at study inclusion and 3 months after study inclusion • Diff BB, Na, K, Urea, Creatinine, proBNP, hsTnT, Lipidelpho, CRP, HbA1c, hsCRP

—

Countries

Germany

Contacts

Public ContactMichael Dreher

Universitätsklinikum Aachen, Medizinische Klinik I

mdreher@ukaachen.de+49 241 8088763

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 15, 2026