NCT02339649

Long-term Cognitive and Cerebral Changes in Sepsis Survivors and Their Predictors

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 308 (estimated)
• Sponsor: German Center for Neurodegenerative Diseases (DZNE) · Academic / Other
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Accepted

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)

Conditions

• Severe Sepsis With Septic Shock
• Severe Sepsis Without Septic Shock

Interventions

Type	Name	Description
PROCEDURE	Blood Sample	Blood Sample
BEHAVIORAL	Neurocognitive Assessment	Neurocognitive Assessment
OTHER	Resting State EEG	10-20 Minutes of Resting State EEG
PROCEDURE	Lumbar Puncture	Lumbar Puncture
OTHER	MRI	60 Minutes MRI

Timeline

• Start date: 2013-09-01
• Primary completion: 2017-10-01
• Completion: 2019-10-01
• First posted: 2015-01-15
• Last updated: 2017-08-01

Locations

2 sites across 1 country: Germany