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

• Conditions: Critical illness encephalopathyDementia; F03; Unspecified dementia

• Registration Number: DRKS00011162
• Lead Sponsor: Kurt-Goldstein-Institut, Privates Institut für Gesundheitsforschung

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 109

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

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 .

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
- Cognitive impairment after 9 months (according to the neuropsychological test scores: CERAD, Strooop: colour-word-interference test)<br>- 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)<br>- Health-dependent quality of life (SF-36)<br>- (Cognitive) functional status according to activity of daily life – measured by the Barthel-Index and IQCODE (interview with relatives)<br>- Mental impairment (Hospital Anxiety and - Depression Scale - HADS)<br>- Intrahospital Mortality<br>- 9-Months Mortality<br>