Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01463995

Acronym

proNICU

Enrollment

Registered

2011-11-02

Start date

2012-06-30

Completion date

2016-10-03

Last updated

2018-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurological Diseases

Keywords

severe neurological diseases, neurological intensive care unit, prediction, long-term outcome, biomarkers, prediction of long-term outcome

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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
Transcriptome analyses	one year after symptom onset	To perform transcriptome analyses to identify new biomarkers which may predict the one year- neurological outcome
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
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
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
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

Countries

Germany

Outcome results