Trial document




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  DRKS00000650

Trial Description

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Title

Neurological Sequelae of Sepsis: Chronic dysphagia in patients with critical illness polyneuropathy (CIP) or myopathy (CIM)

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Trial Acronym

NeuroSOS-DYSPHAGIA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Patients with blood poisoning in an intensive care unit often also suffer from swallowing and nutrition problems, not only during the acute phase, but also as long-term complaint. Neither are the exact causes of these swallowing problems known, nor are the occurring severities well described. We assume that neural and muscular dysfunctions are crucial factors for the development and persistence of swallowing problems associated with sepsis. This hypothesis will be assessed in the course of the present study. For that purpose, septic patients will be subject to standard ear, nose, and throat examinations as well as endoscopic swallowing evaluation (fiberoptic endoscopic evaluation of swallowing, FEES) 2 weeks and 4 months after the onset of disease. The results of this study will help us to develop therapies in order to prevent chronic swallowing problems in patients suffering from blood poisoning.

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Brief Summary in Scientific Language

Swallowing and nutrition problems are a major issue for septic patients in the intensive care unit not only in the acute phase but also as long-term complaint. In the first weeks after onset of sepsis persisting major neurological symptoms, physical weakness, and presence of a tracheotomy seem to be major negative factors disturbing swallowing. But dysphagia often persists even after disappearance of the mentioned factors after the early rehabilitation phase. Not much data is available on long-term dysphagia and its risk factor in patients who have been treated on an ICU for sepsis, although it is known that persistent severe dysphagia is a major negative risk factor for survival. The high mortality rate in patients with severe chronic dysphagia is probably related to the high frequency of aspiration and aspiration-related diseases like pneumonia, infections, or bleeding. Because critical illness polyneuropathy (CIP) and critical illness myopathy (CIM) are major neuromuscular sequelae of critical illness in septic patients we hypothesize that CIP and CIM are major factors for the development and persistence of swallowing malfunction in patients with chronic dysphagia and prior sepsis. Therefore we will assess the swallowing function in at least 150 septic patients who were examined for CIP and CIM within one week after onset of sepsis in the study projects NeuroSOS-CIP and NeuroSOS-NERVE. Two weeks and four months later dysphagia the patients are assessed by fiberoptic endoscopic evaluation of swallowing (FEES) and a set of swallowing and nutrition related scores. At the second time point at 4 months all patients with a FEES score > 1 are examined and scored by standardized videofluoroscopy. The objective of the study is to examine CIP/CIM as an independent risk factor for the development of chronic dysphagia defined by a FEES penetration-aspiration score > 4 at T2 in septic patients. The evaluation of the data will allow us to design an interventional study with the aim to reduce the rate of chronic dysphagia in septic patients with CIP/CIM. This is the reason why we limit the present exploratory study to 24 months. This will allow us to bring in an interventional study in the third year of the CSCC program.

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Organizational Data

  •   DRKS00000650
  •   2011/01/31
  •   [---]*
  •   yes
  •   Approved
  •   2771-02/10, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   A41.9 -  Septicaemia, unspecified
  •   G62.8 -  Other specified polyneuropathies
  •   R13.9 -  [generalization R13: Dysphagia]
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Interventions/Observational Groups

  •   After 2 weeks patients will be examined using fiberoptic endoscopic evaluation of swallowing (FEES) and they will be scored according to the Penetration Aspiration Scale (PAS). Thereby we assess, whether food residues penetrate the trachea or not. Additionally, the nutritional status will be described using the Functional Oral Intake Scale (FOIS), which is graded from no to complete oral nutrition without restriction. Furthermore we will control a set of swallowing- and nutrition-related parameters such as tracheotomy, tongue movement, vocal cord mobility etc. All examinations will be repeated after 4 months. In addition, patients with a PAS score >1 will be examined using standardised videofluoroscopy.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Dysphagia at T2 defined as FEES PAS score > 4

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Secondary Outcome

The secondary outcome are the endoscopic evaluation of swallowing (FEES) and the score according to the Penetration Aspiration Scale (PAS) after 2 weeks and 4 months. Additionally, all patients with a PAS score >1 will be subject to videofluoroscopy. Moreover, patients will be scored according to the Functional Oral Intake Scale after 2 weeks and after 4 months. Further swallowing- and nutrition-related parameters, such as aspiration of saliva, tongue movement, vocal cord mobility, and pneumonia, CIP/CIM as an independent risk factor for the development of chronic dysphagia defined by a FEES penetration-aspiration score > 4 at T2 in septic patients will be assessed as well.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/02/23
  •   150
  •   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

Patients with severe sepsis and/or septic shock according to the ACCP/SCCM

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Exclusion Criteria

Patient has a history of diseases with high risk for polyneuropathia/myopathia: neuromuscular disorders, diabetes mellitus, alcohol abuse, steroid therapy due to asthma, COPD, etc.; patient is likely to die within less than 24 hours.

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Addresses

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    • HNO-Klinik Universität Jena
    • Mr.  Professor  Orlando  Guntinas-Lichius 
    • Lessingstrasse 2
    • 07740  Jena
    • Germany
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    • HNO-Klinik Universität Jena
    • Mr.  Professor  Orlando  Guntinas-Lichius 
    • Lessingstrasse 2
    • 07740  Jena
    • Germany
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    • HNO-Klinik Universität Jena
    • Mr.  Professor  Orlando  Guntinas-Lichius 
    • Lessingstrasse 2
    • 07740  Jena
    • Germany
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Sources of Monetary or Material Support

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    • CSCC Jena (Center for Sepsis Control and Care)
    • Mr.  Professor  Orlando  Guntinas-Lichius 
    • D-07747  Jena
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/03/31
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Trial Publications, Results and other Documents

  •   1.) Intensivpflege 10/2014, S.28-34, Springer Verlag. J. Zielske, S. Bohne, H. Axer, F.M. Brunkhorst, O. Guntinas-Lichius. Mehr Aufmerksamkeit für Langzeitschluckstörungen. 2.) Medizinische Klinik Intensivmedizin Notfallmedizin 2014, 109:516-525 SpringerMedizin. DOI 10.1007/s00063-0130217-3. J. Zielske, S. Bohne, H. Axer, F.M. Brunkhorst, O. Guntinas-Lichius. Dysphagie-Management im Akut- und Langzeitverlauf bei kritisch kranken intensivpflichtigen Patienten. 3.) Eur Arch Otorhinolarygol (2014) 271:3085-3093 DOI 10.1007/s00405-014-3148-6. Acute and long-term dysphagia in critically ill patients with severe sepsis: results of a prospective contrplled observational study. Joerg Zlelske, Silvia Bohne, Frank M. Brunkhorst, Hubertus Axer, Orlando Guntinas-Lichius.
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* This entry means the parameter is not applicable or has not been set.