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CompletedNCT01463995proNICUUpdated Nov 29, 2018

Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort)

An observational study in Neurological Diseases, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-29.

Sponsored by Charite University, Berlin, Germany · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
46
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Neurological Diseases

Keywords

  • severe neurological diseases
  • neurological intensive care unit
  • prediction
  • long-term outcome
  • biomarkers
  • prediction of long-term outcome
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In context

Nervous System Diseases

974 studies on the registry are indexed under Nervous System Diseases; 252 are open to participants now.

This study's enrollment of 46 is below the median of 127 across 318 observational studies indexed under Nervous System Diseases.

Browse Nervous System Diseases studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients with severe neurological diseases treated on a neurological intensive care unit

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

Exclusion Criteria:

  • participation in an interventional trial
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
46 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • severe neurological diseases

    Patients with severe neurological diseases treated on the neurological intensive care unit

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What researchers measure

Primary outcomes

  1. 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

    Time frame: one year after symptom onset

Secondary outcomes

  1. 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

    Time frame: one year after symptom onset

  2. 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

    Time frame: one year after symptom onset

  3. 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

    Time frame: one year after symptom onset

  4. Transcriptome analyses

    To perform transcriptome analyses to identify new biomarkers which may predict the one year- neurological outcome

    Time frame: one year after symptom onset

  5. 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

    Time frame: one year after symptom onset

  6. 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

    Time frame: one year after symptom onset

  7. 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

    Time frame: one year after symptom onset

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Study locations

1 site
  • Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
    Berlin, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01463995
Lead sponsor
Charite University, Berlin, Germany
Collaborators
NeuroCure Clinical Research Center, Charite, Berlin
Responsible party
Andreas Meisel (Prof. Dr. med. Andreas Meisel, Charite University, Berlin, Germany) — Principal investigator
First posted
Nov 2, 2011
Start date
Jun 2012
Primary completion
Oct 3, 2016
Completion
Oct 3, 2016
Last update
Nov 29, 2018

Study contacts

Andreas Meisel, MD
principal investigator · Charite University Berlin (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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