Trial document





This trial has been registered retrospectively.
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  DRKS00011162

Trial Description

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Title

Longterm Cognitive Impairment after ICU- Treatment - a prospective longitudinal cohort study

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Trial Acronym

Cog-I-CU

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URL of the Trial

http://-

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Brief Summary in Lay Language

On completing intensive-care treatment, patients often appear to have cognitive impairment which can be expressed as acquired brain damage which in literature is frequently referred to as "critical illness encephalopathy". This phenomenon seems to be independent of the cause of hospitalization or age and has so far not been well understood concerning further characteristics nor underlying causes. Additionally, there is no existing data on relevant consequences on daily life which intensive care treatment may have on patients with already pre-existing (mild) cognitive impairment. The goal of this study is to examine whether critically ill patients that required treatment on intensive-care may be at risk of developing cognitive impairment, whether the cognitive impairment may persist and which underlying causes may be identifiable. Further the study will try to shed light on the group of patients with already pre-existing (mild) cognitive impairment.

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Brief Summary in Scientific Language

On completion of intensive-care treatment, patients often show cognitive impairment, which is described as "Critical illness encephalopathy" (CIP). This phenomenon seems to be independent of the type of disease or age. It could be demonstrated in more than 20 studies that patients treated on both surgical and conservative intensive care units could show signs of cognitive impairment up to several years after completion of treatment (Eckenhoff und Laudansky 2013, Hopkins et al. 2005, Jackson und Ely 2013). Possible causes may be mechanism associated with neuroinflammation, blood glucose alterations, hypoxemia, sedative medication and hypotension. In prospective studies, the occurrence of delirium and its duration could be indentified as an independent risk factor (Pandharipande et al. 2013, Van den Boogaard et al. 2012). The cognitive impairment includes parts of memory function, attention and executive function and is seen as a separate entity (such as the tendency towards improvement over time) from dementia, although there are hints that critical illness has the potential to worsen pre-existing cognitive impairment (Larson et al. 2007, Wergin und Modrykamien 2012). Goal of this study is to identify further characteristics and possible causes of CIP and to analyze the development over time after intensive care treatment in patients with and without pre-existing (mild) cognitive impairment.

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Organizational Data

  •   DRKS00011162
  •   2016/11/02
  •   [---]*
  •   yes
  •   Approved
  •   314-15-24082015, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

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

  •   Critical illness encephalopathy
  •   Dementia
  •   F03 -  Unspecified dementia
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Interventions/Observational Groups

  •   Patients who receive intensive care treatment and who obtain a value of >= 3,2 in the interview with a close relative/partner (IQCODE= Informant Questionnaire on Cognitive Decline in the Elderly); Collection of data concerning vital signs, lab results, artificial respiration, events like surgery or complications and CNS-influencing medication over the course of the hospital stay (intensiv care and normal ward) up until the first test phase (s. below). Diagnostics: 1. Within 7 days after transferral to the normal ward cognitive testing und neurological examination, 2. Follow-up after 9 months: Cognitive testing, neurological examination, Barthel-Index and subjectiv health condition.
  •   Patients who receive intensive care treatment and who obtain a value of < 3,2 in the interview with a close relative/partner (IQCODE); Collection of data concerning vital signs, lab results, artificial respiration, events like surgery or complications and CNS-influencing medication over the course of the hospital stay (intensiv care and normal ward) up until the first test phase (s. below). Diagnostics: 1. Within 7 days after transferral to the normal ward cognitive testing und neurological examination, 2. Follow-up after 9 months: Cognitive testing, neurological examination, Barthel-Index and subjectiv health condition.
  •   Controll Group matched according to age, sex, level of education and cardiovascular risk Profile. Diagnostics: Cognitive testing and neurological examination.
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Characteristics

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

Scores from neuropsycholocial tests at day 0 (CERAD, Stroop: colour-word-interference test)

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Secondary Outcome

- Cognitive impairment after 9 months (according to the neuropsychological test scores: CERAD, Strooop: colour-word-interference test)
- Newly diagnosed neurological disease (Dementia – defined by the CERAD test result after 9 months, idiopathic parkinsons-syndrom – measured by UPDRS III and diagnosed by outpatient neurologist)
- Health-dependent quality of life (SF-36)
- (Cognitive) functional status according to activity of daily life – measured by the Barthel-Index and IQCODE (interview with relatives)
- Mental impairment (Hospital Anxiety and - Depression Scale - HADS)
- Intrahospital Mortality
- 9-Months Mortality

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/01/20
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   30   Years
  •   90   Years
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Additional Inclusion Criteria

1. Women and man between 30 and 90 years of age.
2. Treatment on either surgical and/or conservative intensive care unit
3. Written consent by the study participant or his/her authorized representative or verbal agreement in front of witnesses

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Exclusion Criteria

1. Acute neurological disease with cerebral involvement (stroke, traumatic-brain-injury, ect.).
2. Intensive care treatment >= 7 days within the last 2 years preceding the current hospitalization.
3. Pre-existing cognitive impairment due to other diagnosed diseases: Dementia (f.ex. Alzheimer’s Disease, other neurodegenerative diseases (f.ex. M.Parkinson), traumatic brain injury, epilepsia, subarachnoid hemorrhage, psychiatric disease, stroke within the last 6 months or with known cognitive impairment.
4. Interview with relatives not possible.
5. IQCODE result (obtained by interview with relatives) >= 3,9.
6. Nursing level >=2 (also application process) and/or institutionalized nursing care; exception: assisted living.
7. Pre-existing liver cirrhosis, pre-existing chronic kidney insufficiency with dialysis, pre-existing lung disease (f.ex. COPD) with home oxygen therapy, pre-existing malignant disease with ongoing chemotherapy.
8. Expectation not to survive the course of the study (One-Year-survival-probability < 50%).
9. Lack of ability to participate in the tests (f.ex. language barrier, impaired vigilance, muscle disease ect.).
10. Treatment for more than 48 hours on an intensive care unit of a non-participating hospital immediately preceding the current intensive care treatment .

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Addresses

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    • Kurt-Goldstein-Institut, Privates Institut für Gesundheitsforschung
    • Saidaer Straße
    • 01731  Kreischa
    • Germany
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    • Zentrum für klinische Studien Leipzig KKS
    • Mr.  Dr. rer.nat.  Meinhard  Mende 
    • Härtelstraße 16/18
    • 04107  Leipzig
    • Germany
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    • Klink und Poliklinik für Neurologie, Universitätsklinikum Leipzig
    • Mr.  Prof. Dr. med.  Joseph  Claßen 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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    • Klink und Poliklinik für Neurologie, Universitätsklinikum Leipzig
    • Ms.  Dr. med.  Judith  v.Hofen-Hohloch 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Kurt-Goldstein-Institut, Privates Institut für Gesundheitsforschung
    • Saidaer Straße
    • 01731  Kreischa
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

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