Trial document




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  DRKS00010050

Trial Description

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Title

Mid-German Sepsis Cohort

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Trial Acronym

MSC

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URL of the Trial

http://www.msc.med.uni-jena.de

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Brief Summary in Lay Language

The Mid-German Sepsis Cohort (MSC) is planned as the worldwide largest cohort study, collecting data on functional, cognitive and mental sequelae and changes in quality of life after ICU-treated severe sepsis. The MSC is a patient cohort with a recruitment period of 3 years and a planned funded follow-up for 1 year for all MSC patients, subsequent follow-ups for up to 5 years will depend on additional funding. 6 participating centers are involved in recruitment. Inclusion criteria are ICU-treated severe sepsis/ septic shock, age ≥18 and informed consent. There are no exclusion criteria.

After ICU discharge, patients will be followed up for as long as possible in regular intervals. Beside general patient characteristics and data on ICU treatment, functional abilities will be gathered (i.e. walking, dressing, bathing). Furthermore, additional patient relevant endpoints will be assessed, including health-related quality of life, cognitive dysfunction, posttraumatic stress symptoms, anxiety and depression, pain, quality of sleep, weight, resumption of work.

Ultimately, the results generated from this study will contibute to development of specific rehabilitation measures.

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Brief Summary in Scientific Language

The MSC is planned as a cohort of adult patients with ICU-treated severe sepsis and septic shock. Participants will be recruited in the ICUs of six large hospitals in mid-Germany. The aim is to include 3,000 patients during a period of 3 years to obtain a sufficiently large sample of survivors discharged from the ICU.

Main objective: To ascertain the distribution or prevalence of functional (dis)ability and to assess prognostic factors by prospectively performing individualized assessments of physical, functional, and quality of life measures in patients after ICU-treated severe sepsis and septic shock during 5 years after ICU discharge;

Specific objective: To assess the course (distributions, prevalences) and prognostic factors (i.e. potential determinants) of mortality (including cause-specific mortality), morbidity (including functional (dis)ability, physical disability, neuropsychological disability, neuromuscular disability), and post-sepsis infection-related complications.

The primary outcome will be functional ability, defined by activities of daily living (ADLs: walking, dressing, bathing, eating, getting into and out of bed, and toileting) or instrumental ADLs (IADLs: preparing a hot meal, shopping for groceries, making telephone calls, taking medicines, and managing money). Analyses are done to individual changes in total score between ICU discharge and current follow up. These patient-relevant outcomes will allow a comprehensive assessment of the burden of post-sepsis syndrome. ADLs can be assessed by telephone interviews with patients or their proxies.

Key secondary outcomes:
Health-related Quality of Life (HrQoL): EQ-5D-3L to assess HrQoL. Cognitive dysfunction will be assessed using the telefon-MOCA (Montreal cognitive assessment) or IQCODE (Informant Questionnaire on Cognitive Decline) by interviewing a proxy. Posttraumatic stress symptoms will be assessed by PTSS-10 questionnaire. PHQ-9 questionnaire will be used to assess symptoms of anxiety and depression. Symptoms of fatique will be queried by using the Chalder fatigue scale. A 4-point Likert scale is used to determine impairment of swallowing, smelling, hearing and taste. Furthermore the Graded Chronic Pain Scale, the Regensburg Insomnia Scale (RIS) and the IDPain (neuropathic pain) questionnaires will be used. Further outcomes will include medication, use of medical services (rehablilitation, hospitalization, out-patient therapy) recurrent infections and sepsis, reintegration and return to work, presumed cause of death and other long term effects like dialysis, long term ventilation and nursing care.

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Organizational Data

  •   DRKS00010050
  •   2016/03/22
  •   [---]*
  •   yes
  •   Approved
  •   4669-01/16, 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

  •   R65.1 -  Systemic Inflammatory Response Syndrome of infectious origin with organ failure
  •   R57.2 -  Septic shock
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Interventions/Observational Groups

  •   After ICU discharge, patients will be surveyed for as long as possible in regular intervals: 3 months, 6 months, 12 months, 24 months, 36 months, 48 months und 60 months after ICU discharge. Beside general patient characteristics and data on ICU treatment, functional abilities will be gathered (i.e. walking, dressing, bathing). Furthermore, additional patient relevant endpoints will be assessed including health-related quality of life, cognitive dysfunction, posttraumatic stress symptoms, anxiety and depression, pain, quality of sleep, weight, resumption of work.
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Characteristics

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

Functional ability as defined by six activities of daily living (ADLs: walking, dressing, bathing, eating, etc.) or five instrumental activities of daily living (IADLs: preparing a hot meal, shopping for groceries, making telephone calls, etc.); taken together as "activities of daily living" (ADL) and "instrumental activities of daily living" (IADL), displayed in the so-called “Frührehabilitations-Barthel-Index (FRB)” and Barthel index, respectively. Analyses are done to detect individual changes in total score between ICU discharge and current follow up: 3 months, 6 months, 12 months, 24 months, 36 months, 48 months und 60 months after ICU discharge.

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Secondary Outcome

Overall and cause-specific survival, number of recurrent infections, health-related quality of life (EQ-5D-3L), cognitive deficiency score (telefon-MOCA, IQCODE), weight, return to work, posttraumatic stress (PTSS-10), anxiety and depression (PHQ-9). Inquiry at 3 months, 6 months, 12 months, 24 months, 36 months, 48 months und 60 months after ICU discharge - via interview/questionnaires.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2016/04/15
  •   3000
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

ICU-treated severe sepsis or septic shock

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Exclusion Criteria

previous participation in the MSC-study

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Addresses

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    • Integriertes Forschungs- und Behandlungszentrum (IFB) SepsisCenter for Sepsis Control and Care (CSCC)
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • Universitätsklinikum JenaKlinik für Anästhesiologie und Intensivmedizin
    • Mr.  Prof. Dr.  Konrad  Reinhart 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • Universitätsklinikum Jena Integriertes Forschungs‐ und Behandlungszentrum (IFB) SepsisCenter for Sepsis Control and Care (CSCC)Klinische Epidemiologie
    • Mr.  Prof. Dr.  André  Scherag 
    • Salvador‐Allende‐Platz 27
    • 07747  Jena
    • Germany
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    • Universitätsklinikum JenaKlinik für Anästhesiologie und Intensivmedizin
    • Ms.  PD Dr.  Christiane  Hartog 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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    • Rudolf Presl GmbH
    • 01731  Kreischa
    • 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.