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

Severe Sepsis With Septic Shock Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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) ;

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis With Septic Shock
• Severe Sepsis Without Septic Shock
• Shock
• Shock, Septic
• Toxemia

• NCT number: NCT02339649
• Study type: Interventional
• Source: German Center for Neurodegenerative Diseases (DZNE)
• Contact: Catherine N. Widmann, M.A.
• Phone: +49 (0)228 287 13093
• Email: catherine.widmann@dzne.de
• Status: Recruiting
• Phase: N/A
• Start date: September 2013
• Completion date: October 2019