Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort) (proNICU)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Andreas Meisel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01463995
First received: October 31, 2011
Last updated: January 20, 2016
Last verified: January 2016

October 31, 2011
January 20, 2016
June 2012
December 2016   (final data collection date for primary outcome measure)
Predictive properties of immune parameters (IL6, IL10, mHLA-DR) for functional outcome one year after symptom onset [ Time Frame: one year after symptom onset ] [ Designated as safety issue: No ]
To evaluate of the predictive properties of immune parameters (IL6, IL10, mHLA-DR) for functional outcome one year after symptom onset
Same as current
Complete list of historical versions of study NCT01463995 on ClinicalTrials.gov Archive Site
  • To evaluate of the predictive properties of clinical scores for functional outcome one year after symptom onset [ Time Frame: one year after symptom onset ] [ Designated as safety issue: No ]
    To evaluate of the predictive properties of clinical scores for functional outcome one year after symptom onset
  • To evaluate of the predictive properties of electrophysiological measurements one year after symptom onset [ Time Frame: one year after symptom onset ] [ Designated as safety issue: No ]
    To evaluate of the predictive properties of electrophysiological measurements one year after symptom onset
  • To evaluate of the predictive properties of conventional (DTI) and functional imaging (resting state) one year after symptom onset [ Time Frame: one year after symptom onset ] [ Designated as safety issue: No ]
    To evaluate of the predictive properties of conventional (DTI) and functional imaging (resting state) one year after symptom onset
  • Transcriptome analyses [ Time Frame: one year after symptom onset ] [ Designated as safety issue: No ]
    To perform transcriptome analyses to identify new biomarkers which may predict the one year- neurological outcome
  • Predictive properties of immune parameters in the cerebrovascular fluid for functional outcome one year after symptom onset [ Time Frame: one year after symptom onset ] [ Designated as safety issue: No ]
    To evaluate of the predictive properties of immune parameters in the cerebrovascular fluid for functional outcome one year after symptom onset
  • Quality of life and occurence of depression in patients one year after symptom onset [ Time Frame: one year after symptom onset ] [ Designated as safety issue: No ]
    To investigate the quality of life and the occurence of depression in patients one year after symptom onset
  • Quality of life and the occurence of depression and burnout syndrome in relatives [ Time Frame: one year after symptom onset ] [ Designated as safety issue: No ]
    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
  • To evaluate of the predictive properties of clinical scores for functional outcome one year after symptom onset [ Time Frame: one year after symptom onset ] [ Designated as safety issue: No ]
    To evaluate of the predictive properties of clinical scores for functional outcome one year after symptom onset
  • To evaluate of the predictive properties of electrophysiological measurements one year after symptom onset [ Time Frame: one year after symptom onset ] [ Designated as safety issue: No ]
    To evaluate of the predictive properties of electrophysiological measurements one year after symptom onset
  • To evaluate of the predictive properties of conventional (DTI) and functional imaging (resting state) one year after symptom onset [ Time Frame: one year after symptom onset ] [ Designated as safety issue: No ]
    To evaluate of the predictive properties of conventional (DTI) and functional imaging (resting state) one year after symptom onset
  • Transcriptome analyses [ Time Frame: one year after symptom onset ] [ Designated as safety issue: No ]
    To perform transcriptome analyses to identify new biomarkers which may predict the one year- neurological outcome
  • Predictive properties of immune parameters in the cerebrovascular fluid for functional outcome one year after symptom onset [ Time Frame: one year after symptom onset ] [ Designated as safety issue: No ]
    To evaluate of the predictive properties of immune parameters in the cerebrovascular fluid for functional outcome one year after symptom onset
  • Quality of life and occurence of depression in patients one year after symptom onset [ Time Frame: one year after symptom onset ] [ Designated as safety issue: No ]
    To investigate the quality of life and the occurence of depression in patients one year after symptom onset
  • Quality of life and the occurence of depression and bournout syndrome in relatives [ Time Frame: one year after symptom onset ] [ Designated as safety issue: No ]
    To investigate the quality of life and the occurence of depression and bournout syndrome in relatives of patients treated on the neurological intensive care unit one year after symptom onset
Not Provided
Not Provided
 
Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort)
Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort)
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Blood samples (serum, plasma), cerebrovascular fluid
Probability Sample
patients with severe neurological diseases treated on a neurological intensive care unit
Neurological Diseases
Not Provided
severe neurological diseases
Patients with severe neurological diseases treated on the neurological intensive care unit
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2016
December 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Andreas Meisel, MD +49 30 450 ext 560026 andreas.meisel@charite.de
Germany
 
NCT01463995
proNICU cohort
No
Not Provided
Not Provided
Andreas Meisel, Charite University, Berlin, Germany
Charite University, Berlin, Germany
Not Provided
Principal Investigator: Andreas Meisel, MD Charite University Berlin (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
Charite University, Berlin, Germany
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP