Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort)

Neurological Diseases Clinical Trial

— proNICU  

Official title:

Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463995
• Other study ID #: proNICU cohort
• Status: Completed
• Start date: June 2012
• Est. completion date: October 3, 2016

Study information

• Verified date: November 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 3, 2016
• Est. primary completion date: October 3, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nervous System Diseases
• Neurological Diseases

Locations

Country	Name	City	State
Germany	Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	NeuroCure Clinical Research Center, Charite, Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive properties of immune parameters (IL6, IL10, mHLA-DR) for functional outcome 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	one year after symptom onset
Secondary	To evaluate of the predictive properties of clinical scores 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
Secondary	To evaluate of the predictive properties of electrophysiological measurements one year after symptom onset	To evaluate of the predictive properties of electrophysiological measurements one year after symptom onset	one year after symptom onset
Secondary	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 conventional (DTI) and functional imaging (resting state) one year after symptom onset	one year after symptom onset
Secondary	Transcriptome analyses	To perform transcriptome analyses to identify new biomarkers which may predict the one year- neurological outcome	one year after symptom onset
Secondary	Predictive properties of immune parameters in the cerebrovascular fluid for functional outcome 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	one year after symptom onset
Secondary	Quality of life and occurence of depression in patients one year after symptom onset	To investigate the quality of life and the occurence of depression in patients one year after symptom onset	one year after symptom onset
Secondary	Quality of life and the occurence of depression and burnout syndrome in relatives	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	one year after symptom onset