Long-term Cognitive and Cerebral Changes in Sepsis Survivors and Their Predictors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Severe Sepsis With Septic Shock
- Sponsor
- German Center for Neurodegenerative Diseases (DZNE)
- Enrollment
- 308
- Locations
- 2
- Primary Endpoint
- Verbal Learning Memory Test Long Delayed Recall (Trial 7)
- Last Updated
- 8 years ago
Overview
Brief Summary
The main goals of this study are to provide a cognitive, neurological, brain morphological, and serological profile of sepsis survivors in order to make long-term prognosis of recovery and estimate the need for rehabilitation measures in order to help patients reintegrate into normal daily life.
Detailed Description
Comparison of cognitive function in severe septic/septic shock ICU patients with non-septic postoperative ICU patients and actively recruited healthy controls at several time points up to 12 months after leaving the ICU. Secondary aims: * Profiling specific cognitive deficits in sepsis survivors over time. * Identifying possible subclasses of long-term cognitive impairment according to facets of disease, therapy and ICU experience. * Investigating long-term brain morphological changes, with hippocampus as region of interest (ROI). * Determining values of Serum- and CSF-Biomarkers * Evaluation of diagnostic and prognostic value of non-routine biomarkers for systemic- and neuroinflammation in the acute phase and in the long-term * Investigate associations between brain morphological changes, cognitive changes, neurological status, psychiatric burden, disability level, employment status and health-related quality of life (HRQOL). * Investigating brain-activity changes in resting state electro-encephalogram (EEG)
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Verbal Learning Memory Test Long Delayed Recall (Trial 7)
Time Frame: 6 months post ICU
Verbal Learning Memory Test Long Delayed Recall (Trial 7) at 6 months post ICU admission in sepsis/septic shock patients versus non-septic postoperative patients, and comparison to actively recruited healthy controls)
Secondary Outcomes
- German Vocabulary Test(For patient groups: 12 months; for Healthy Controls: 6 months)
- Wechsler Memory Scale IV Visual Recall I and II(For patient groups: 12 months; for Healthy Controls: 6 months)
- Verbal Learning Memory Test, German Version(For patient groups: 12 months; for Healthy Controls: 6 months)
- Wechsler Memory Scale Digit-Span(For patient groups: 12 months; for Healthy Controls: 6 months)
- Trail Making Test A & B(For patient groups: 12 months; for Healthy Controls: 6 months)
- Symbol Digit Modalities Test(For patient groups: 12 months; for Healthy Controls: 6 months)
- Patient Health Questionnaire Subtests Depression, Anxiety and Somatic Symptoms(For patient groups: 12 months; for Healthy Controls: 6 months)
- Post-Traumatic Stress Syndrome 10(For patient groups: 12 months; for Healthy Controls: 6 months)
- MRI (3 Tesla) of brain with hippocampus as Region of Interest(For patient groups: 6 months, 12 months; for Healthy Controls: Baseline and 6 months)
- Lumbar Puncture (voluntary)(For Patients: (while at ICU, if clinically indicated as part of clinical routine and only if patient directly gives informed consent), 12 months; For Healthy Controls: Baseline and 6 months)
- Functional Activities Questionnaire(For patient groups: 12 months; for Healthy Controls: 6 months)
- Clinical Scales at ICU(For Patients during ICU Stay (Day 0, [Day 7 if still on ICU], Day of Release))
- Phonetic and Lexical Verbal Fluency(For patient groups: 12 months; for Healthy Controls: 6 months)
- European Quality of Life 5 Dimensions-5 Levels(For patient groups: 12 months; for Healthy Controls: 6 months)
- modified version of Rankin Scale Structured Interview (modified for ICU patients)(For patient groups: 12 months; for Healthy Controls: 6 months)
- Pittsburgh Sleep Quality Index(For patient groups: 12 months; for Healthy Controls: 6 months)
- Neurological Examination(For patient groups: 6 months, 12 months; for Healthy Controls: Baseline and 6 months)
- resting state electroencephalogram(For patient groups: 6 months, 12 months; for Healthy Controls: Baseline and 6 months)
- Mini Mental Status Examination(For patient groups: 12 months; for Healthy Controls: 6 months)
- Blood Sample(For Patient Groups 2-3 samples during ICU, 3-4 Months, 6 months, 12 Months)