Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort)

Completed

• Conditions: Neurological Diseases

• Registration Number: NCT01463995
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

This study examines the prognostic properties of immune parameters, clinical scores, electrophysiological tests (eeg, ssep, emg, eng) and functional imaging for the prediction of functional outcome one year after treatment on a neurological intensive care unit.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-31
• Study First Submitted QC: 2011-11-01
• Study First Posted: 2011-11-02
• Study Start: 2012-06
• Primary Completion: 2016-10-03
• Study Completion: 2016-10-03
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-28
• Last Update Posted: 2018-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• severe neurological disease making treatment on a neurological intensive care unit necessary
• age ≥ 18
• consent by the patient or the legal representative

Exclusion Criteria

• participation in an interventional trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive properties of immune parameters (IL6, IL10, mHLA-DR) for functional outcome one year after symptom onset	one year after symptom onset	To evaluate of the predictive properties of immune parameters (IL6, IL10, mHLA-DR) for functional outcome one year after symptom onset

Secondary Outcome Measures

Name	Time	Method
Predictive properties of immune parameters in the cerebrovascular fluid for functional outcome one year after symptom onset	one year after symptom onset	To evaluate of the predictive properties of immune parameters in the cerebrovascular fluid for functional outcome one year after symptom onset
To evaluate of the predictive properties of clinical scores for functional outcome one year after symptom onset	one year after symptom onset	To evaluate of the predictive properties of clinical scores for functional outcome one year after symptom onset
To evaluate of the predictive properties of conventional (DTI) and functional imaging (resting state) one year after symptom onset	one year after symptom onset	To evaluate of the predictive properties of conventional (DTI) and functional imaging (resting state) one year after symptom onset
To evaluate of the predictive properties of electrophysiological measurements one year after symptom onset	one year after symptom onset	To evaluate of the predictive properties of electrophysiological measurements one year after symptom onset
Quality of life and the occurence of depression and burnout syndrome in relatives	one year after symptom onset	To investigate the quality of life and the occurence of depression and burnout syndrome in relatives of patients treated on the neurological intensive care unit one year after symptom onset
Transcriptome analyses	one year after symptom onset	To perform transcriptome analyses to identify new biomarkers which may predict the one year- neurological outcome
Quality of life and occurence of depression in patients one year after symptom onset	one year after symptom onset	To investigate the quality of life and the occurence of depression in patients one year after symptom onset

Trial Locations

Locations (1)

Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC); 🇩🇪 Berlin, Germany