Trial document




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  DRKS00000652

Trial Description

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Title

"Neurological Sequelae of Sepsis" (NeuroSOS-CIP): Investigation of nerve and muscle in patients with critical illness polyneuropathy (CIP) using MRI

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Trial Acronym

NeuroSOS-CIP

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URL of the Trial

[---]*

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Brief Summary in Lay Language

About 70% of patients with an acute sepsis suffer from an impairment of nerve and muscle. Nerve damage, the so-called critical íllness polyneuropathy (CIP), and damage of muscles, the so-called critical illness myopathy (CIM), are major reasons for weakness of the muscles, prolongated ventilation times, and delayed rehabilitation. This study investigates the changes in nerves and muscles in MRI in the course of sepsis. The gold standard for evaluation of nerve damage is electroneurography. The gold standard to evaluate muscle damage is muscle biopsy. It can be expected that changes in different MR parameters can evaluate nerve and muscle damage.

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Brief Summary in Scientific Language

This study aims at the investigation of critical illness polyneuropathy and myopathy using MRI. Axonal damage occurs in large myeliniated nerve fibres in about 70% of septic patients, i.e. critical illness polyneuropathy, which is the major reason for muscle weakness, prolongated times of artificial respiration and delayed rehabilitation. Axonal damage leads to Wallerian degeneration in the distal nerve but has the potential for regeneration in the peripheral nervous system. MRI is able to visualize these processes in high anatomical detail represented in changes of contrast enhancement, t2weighted signal changes and changes in diffusion weighted imaging in nerve and muscle. MRI will be performed in patients with electroneurographic signs of CIP in the first week after onset of acute sepsis. For classification of critical illness myopathy (CIM) a muscle biopsy will be taken. A second MRI will be done during recovering from sepsis (before hospital discharge). Therefore, we will be able for the first time to localize anatomically the nerve damage in CIP and CIM in high detail, and will be able to define basic pathophysiological processes of regeneration.

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Organizational Data

  •   DRKS00000652
  •   2010/12/28
  •   [---]*
  •   yes
  •   Approved
  •   2770-02/10, 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
  •   G72.8 -  Other specified myopathies
  •   G62.80 -  [generalization G62.8: Other specified polyneuropathies]
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Interventions/Observational Groups

  •   no intervention, diagnostic procedures: screening: electroneurographic measurements. visit 1 (1 week after begin of the acute sepsis): MRI of pelvis and thigh, neurological examination, optional muscle biopsy. visit 2 (3 to 4 weeks later): MRI of pelvis and thigh, electroneurographic measurements, neurological examination.
  •   no intervention, healthy controls, single diagnostic procedures: MRI of pelvis and thigh, electroneurographic measurements
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

1. MR parameters of nerve tissue: changes in T2-weighted sequences, diffusion weighted sequences, gadolinium-enhancement in the ischiadic nerve, the lumbosacral plexus, and the nerve roots. 2. MR parameters in the muscles: changes in T2-weighted sequences, diffusion weighted sequences, gadolinium-enhancement in the quadriceps muscle.
Time points of visitation are in the first week after onset of the acute sepsis and 3 to 4 weeks later.

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Secondary Outcome

1. MR parameters in correlation to electrophysiological measurements (amplitudes, conduction time) (neuropathy). 2. MR parameters in correlation to muscle biopsy results (myopathy).
Time points of visitation are in the first week after onset of the acute sepsis and 3 to 4 weeks later.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Planned
  •   2011/04/08
  •   100
  •   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 CSCC Criteria since ≥4 days.
Consent of study participation. Age ≥ 18 years, diagnosis of CIP according to electroneurographic criteria.

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Exclusion Criteria

Patient has a history of neuromuscular disorders (e.g. polyneuropathy, muscle disease, myasthenia gravis, amyotrophic lateral sclerosis, etc.), known alcohol abuse, known diabetes mellitus, high-dose steroid therapy before sepsis (≥16 mg/kg body weight for 5 days), ICU stay ≥8 days, patient is likely to die within less than 24 hours, participation in another clinical study, contraindication for MRI (e.g. pacemaker)

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Addresses

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    • CSCC Jena (Center for Sepsis Control and Care) Hans Berger Klinik für Neurologie
    • Mr.  PD Dr. med. habil.  Hubertus  Axer 
    • Erlanger Allee 101
    • D-07747  Jena
    • Germany
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    • CSCC Jena (Center for Sepsis Control and Care) Hans Berger Klinik für Neurologie
    • Mr.  PD Dr. med. habil.  Hubertus  Axer 
    • Erlanger Allee 101
    • D-07747  Jena
    • Germany
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    • CSCC Jena (Center for Sepsis Control and Care) Hans Berger Klinik für Neurologie
    • Mr.  PD Dr. med. habil.  Hubertus  Axer 
    • Erlanger Allee 101
    • D-07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Hannoversche Straße 28-30
    • 10115  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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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.