Trial document





This trial has been registered retrospectively.
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  DRKS00007644

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Main purpose of the study is to evaluate, if effective noninvasive ventilation can influence cardiovascular biomarkers in the blood, which might influence inflammatory processes or cardiovascular mechanisms.
Our study group has shown, that noninvasive positive pressure ventilation is capable in reducing elevated carbondioxide levels in patients suffering from chronic obstructive pulmonary disease. Furthermore, noninvasive ventilation improves lung function parameters, health-related quality of life and exercise capacity in these patients.
Taking blood samples before and after initiation of noninvasive ventilation should evaluate the influence of noninvasive ventilation in patients with chronic obstruktive pulmonary disease on inflammation parameters.
Potential study partcipants are patients suffering from chronic obstructive pulmonary disease, in whom a non-invasive ventilation is initiated.
Aim of the study is an better understanding of certain inflammatory markers and therefore improvement of prognosis of patients with chronic obstructive pulmonary disease and cardiovascular diseases. We hypothesize in this study that noninvasive ventilation may reduce inflammatory markers.

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Brief Summary in Scientific Language

Background: Noninvasive positive pressure ventilation (NPPV) using effective pressure levels to reduce chronic hypercapnia have recently been shown to improve survival in stable hypercapnic COPD. However, the underlying mechanism of this improvement remains unclear. One mechanism might be an influence on inflammatory processes or cardiovascular mechanisms.
Methods: The present studies investigated the influence of effective NPPV on a panel of cytokines and established cardiovascular biomarkers. Peripheral blood samples were drawn before and three month after the initiation of NPPV and analyzed by flow cytometric bead array and ELISA.

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Organizational Data

  •   DRKS00007644
  •   2015/01/23
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  •   no
  •   Approved
  •   190/10, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   J44.9 -  Chronic obstructive pulmonary disease, unspecified
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Interventions/Observational Groups

  •   Comparison of blood gas analysis and systemic inflammation parameters in COPD patients, in whom NPPV will be initiated
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Nocturnal PaCO2 measured at 4 a.m. before and after initiation of noninvasive ventilation

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Secondary Outcome

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) IL1β, IL-6, IL-8, MCP-1, TNFα, 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2010/11/08
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

COPD patients in stadium GOLD iV with hypercapnia (PaCO2 > 50 mmHg)

Stable state of disease (pH >7,33)

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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

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Addresses

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    • Firma Resmed
    • Fraunhoferstr.16
    • 82152  Martinsried
    • Germany
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    • Atherogenesis Research GroupUniversitäts-Herz-Zentrum
    • Mr.  Prof. Dr. med.  Andreas  Zirlik 
    • Hugstetter Str.55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Aachen, Medizinische Klinik I
    • Mr.  Prof. Dr.med.  Michael  Dreher 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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    • Universitätsklinikum Aachen, Medizinische Klinik I
    • Mr.  Prof. Dr.med.  Michael  Dreher 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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Sources of Monetary or Material Support

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    • Firma Resmed
    • Fraunhoferstr.16
    • 82152  Martinsried
    • Germany
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    • Abteilung PneumologieUniversitätsklinik Freiburg
    • Killianstr.5
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/10/19
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.