Trial document




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  DRKS00004815

Trial Description

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Title

Long-term Cognitive and Funtional Outcome of Survivors of severe Sepsis following a computerized Cognitive Training

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Trial Acronym

LOSS-Cog-Train

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In Germany there are no standards of rehabilitation-therapy for survivors of severe sepsis. A lot of these patients suffer from different longtime squeals after sepsis, i.e. cognitive impairment. This study examines the efficacy of a computer-based cognitive training in case of cognitive impairment after sepsis. This intervention will be compared with a control group, which only gets an ambulant standard treatment (e.g. physiotherapy, occupational therapy). This is the beginning to standardized concepts about rehabilitation of patients after sepsis.
However, it is an underestimatied problem to motivate survivors of a severe Sepsis, not rarely being in a (rehabilitation) hospital for weeks or month, for participating in a daily cognitive computer training - thatswhy the recruiting of patient for this study was difficult. An amendmend was aproved which include the following protocol changes: reduction of the follow-up from 12 to 9 month, extension of the patient age up to incl. 75 years, extension of the recruiting time frame up to 2 years post Sepsis; addionally, Sepsis survivors were contacted via the "Jena Sepsis Registry" and informed by a letter about the study without any obligation. Besides, taking psychotropic medication at the time point of randomization which can influence cognitive function was defined as an additional exclusion criteria.

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Brief Summary in Scientific Language

In Germany there are no rehabilitation concepts for survivors of severe sepsis or septic shock, although there are several long term sequels after sepsis. One of this long term sequel is cognitive impairment (Iwashyna et al., 2010). In order to find an efficient treatment for these patients (Hopkins & Jackson, 2006), this study was aimed. A computer-based cognitive training will be performed by patients with cognitive deficits and their cognitive and functional outcome will be considered over several months.

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Organizational Data

  •   DRKS00004815
  •   2013/05/02
  •   [---]*
  •   yes
  •   Approved
  •   3305-11/11, 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

  •   Sepsis
  •   A41.9 -  Sepsis, unspecified
  •   F06.7 -  Mild cognitive disorder
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Interventions/Observational Groups

  •   ambulant standard therapy only in control group (e.g. physiotherapy, occupational therapy)
  •   intervention: cognitive training based on computerized cognitive training program (Cog-Train, REHACOM) in addition to standard therapy,
    the training will be accomplished on 6 days per week (30 min every day) for 3 months
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

cognitive function at 3 and 9 months after randomization (neurophysiological tests with a test battery corresponding to individual impairment specific deficites)

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Secondary Outcome

1) Executive cognitive function at 3 and 9 months after randomization, measured by Tower test (Delis et. al. 2004)

2) Functional disability at 3 and 9 months after randomization, evaluated by ADL and IADL according to Iwashyna et. al. 2010

3) impact on cognitive function and functional disability of age, length from beginning of sepsis until study recruitment (in days)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2013/05/03
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

1. Survivors of severe sepsis or septic shock

2. Impaired cognitive functions exist up to two years post Sepsis, which make an intervention reasonable (at least one test of the neuropsychological test battery has a percentile less than 16).

3. signed informed consent

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Exclusion Criteria

1. Patients after an acute event which effects the central nervous system (i.e. stroke, meningitis, intracranial bleeding)
2. Patients with preexisting disease or brain injury affecting cognitive (like Parkinson-dementia complex, HIV-encephalopathy, multiple sclerosis stroke or traumatic brain injury, psychiatric disorder)
3. Patients with severe paresis as a consequence of critical illness polyneuropathy and/or myopathy who can´t handle the computer at time point of randomization
4. Patients with a serious cognitive impairment at time point of randomization (Mini Mental State Exam score </= 20 points)
5. Patients who answer no to question about computer affinity
6. Patients who are included in an other clinical trial
7. Psychotropic co-medication at time point of randomization (like Neuroleptica and Benzodiacepine) which can reduce cognitive function

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Moritz-Klinik Bad Klosterlausnitz
    • Mr.  Prof.  Farsin  Hamzei 
    • Hermann-Sachse Str. 46
    • 07639  Bad Klosterlausnitz
    • Germany
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    • Moritz-Klinik Bad Klosterlausnitz
    • Mr.  Prof.  Farsin  Hamzei 
    • Hermann-Sachse Str. 46
    • 07639  Bad Klosterlausnitz
    • Germany
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    • Moritz-Klinik Bad Klosterlausnitz
    • Mr.  Prof.  Farsin  Hamzei 
    • Hermann-Sachse Str. 46
    • 07639  Bad Klosterlausnitz
    • 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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    • Moritz Klinik Bad Klosterlausnitz
    • Mr.  Prof. Dr. med.  Farsin  Hamzei 
    • Hermann-Sachse Strasse 46
    • 07639  Bad Klosterlausnitz
    • 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.