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

Not Applicable

• Conditions: Sepsis; A41.9; F06.7; Sepsis, unspecified; Mild cognitive disorder

• Registration Number: DRKS00004815
• Lead Sponsor: Moritz-KlinikBad Klosterlausnitz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-02
• Study Completion: 2023-01-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

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

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 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1) Executive cognitive function at 3 and 9 months after randomization, measured by Tower test (Delis et. al. 2004)<br><br>2) Functional disability at 3 and 9 months after randomization, evaluated by ADL and IADL according to Iwashyna et. al. 2010<br><br>3) impact on cognitive function and functional disability of age, length from beginning of sepsis until study recruitment (in days)