Trial document





This trial has been registered retrospectively.
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  DRKS00014030

Trial Description

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Title

Neuropsychological follow-up of patients of the study: "A randomised, controlled, open-label study to confirm the efficacy and safety of sedation with isoflurane in invasively ventilated ICU patients" (Isoconda)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language


Comparison of the long-term outcome (ICU memories, physical and mental health) between patients after sedation with isoflurane and propofol through the use of different questionnaires

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Brief Summary in Scientific Language

Comparison of the occurrence of a delirium as well as the spectrum of memories and the neuropsychological outcome of patients of the Isoconda study

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Organizational Data

  •   DRKS00014030
  •   2018/11/05
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  •   yes
  •   Approved
  •   11/17, Ethik-Kommission bei der Ärztekammer des Saarlandes
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Secondary IDs

  •   2016-004551-67 
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Health Condition or Problem studied

  •   F05.9 -  Delirium, unspecified
  •   F43.9 -  Reaction to severe stress, unspecified
  •   F32.9 -  Depressive episode, unspecified
  •   Z74 -  Problems related to care-provider dependency
  •   PICS (Post-intensive Care Syndrome)
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Interventions/Observational Groups

  •   Isoflurane sedation, dosing with targeted RASS (Richemont Agitation and Sedation Score) for at least 48h (Isoconda study) and subsequent assessment of neuropsychological outcome 1, 3, and 12 months after discharge from ICU (intensive care unit) using separate questionnaires (ICU Memory Tool, SF-36, HADS, WHO-5, PTSS-14)
  •   Propofol sedation, dosing with targeted RASS for at least 48h (Isoconda study) and subsequent assessment of neuropsychological outcome 1, 3, and 12 months after discharge from ICU using separate questionnaires (ICU Memory Tool, SF-36, HADS, WHO-5, PTSS-14)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Prognosis
  •   Parallel
  •   III
  •   Yes
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Primary Outcome

Extent of delusional memories using the Intensive Care Unit (ICU) memory tool 4 weeks, 3 months, and 12 months after discharge from the intensive care unit

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Secondary Outcome

1. Incidence of the occurrence of a delirium 24 hours after extubation using the CAM-ICU (Confusion Assessment Method for the Intensive Care Unit)
2. Frequency of symptoms of posttraumatic stress syndrome based on PTSS-14 (Post-Traumatic Stress Syndrome 14)
3. Health-related quality of life based on the SF-36 (Short Form 36)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2017/12/20
  •   100
  •   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

Participation in the Isoconda study

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Exclusion Criteria

Aphasia, insufficient spoken and written language skills in German, no consent

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
    • Mr.  Prof.  Thomas  Volk 
    • Kirrbergerstraße
    • 66421  Homburg
    • Germany
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    • Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
    • Ms.  Dr. med.  Alexandra  Donie 
    • Kirrbergerstraße
    • 66421  Homburg
    • Germany
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    • Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
    • Ms.  Dr. med.  Alexandra  Donie 
    • Kirrbergerstraße
    • 66421  Homburg
    • Germany
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Sources of Monetary or Material Support

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    • Sedana Medical AB
    • Kungsgatan 62
    • SE-753 18  Uppsala
    • Sweden
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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