Neurological DiseasesproNICUNCT01463995
Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort)
An observational study of Neurological Diseases, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurological Diseases
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2012to 3 Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with severe neurological diseases treated on a neurological intensive care unit
Who may be able to join
- severe neurological disease making treatment on a neurological intensive care unit necessary
- age ≥ 18
- consent by the patient or the legal representative
Who cannot join
- participation in an interventional trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
Berlin
About this study
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.
- Conditions
- Neurological Diseases
- Keywords
- severe neurological diseases, neurological intensive care unit, prediction, long-term outcome, biomarkers, prediction of long-term outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| severe neurological diseases | Patients with severe neurological diseases treated on the neurological intensive care unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year after symptom onset
Secondary outcomes (7)
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
Measured: 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 electrophysiological measurements one year after symptom onset
Measured: 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 conventional (DTI) and functional imaging (resting state) one year after symptom onset
Measured: one year after symptom onset
Transcriptome analyses
To perform transcriptome analyses to identify new biomarkers which may predict the one year- neurological outcome
Measured: one year after symptom onset
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
Measured: one year after symptom onset
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
Measured: one year after symptom onset
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
Measured: one year after symptom onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2011 (estimated)
- Study startJun 2012
- Primary completion3 Oct 2016
- Study completion3 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological DiseasesStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroCure Clinical Research Center, Charite, Berlin
- Responsible party
- Principal investigator, Andreas Meisel, Charite University, Berlin, Germany
- Investigators
- Andreas Meisel, MD, Principal investigator, Charite University Berlin (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463995
- Sponsor's protocol ID
- proNICU cohort
- Acronym
- proNICU
- Status last verified
- Nov 2018
- First submitted
- 31 Oct 2011
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort)
- ClinicalTrials.gov ID
- NCT01463995
- Acronym / sponsor ID
- proNICU / proNICU cohort
- Conditions
- Neurological Diseases
- Keywords
- severe neurological diseases, neurological intensive care unit, prediction, long-term outcome, biomarkers, prediction of long-term outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- NeuroCure Clinical Research Center, Charite, Berlin
- Study start
- Jun 2012
- Primary completion
- 3 Oct 2016 (actual)
- Study completion
- 3 Oct 2016 (actual)
- First posted
- 2 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| severe neurological diseases | – | –Patients with severe neurological diseases treated on the neurological intensive care unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with severe neurological diseases treated on a neurological intensive care unit
Key inclusion criteria (3 listed)
- severe neurological disease making treatment on a neurological intensive care unit necessary
- age ≥ 18
- consent by the patient or the legal representative
Key exclusion criteria (1 listed)
- participation in an interventional trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive properties of immune parameters (IL6, IL10, mHLA-DR) for functional outcome one year after symptom onset
Time frame: 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
7 secondary outcomes
To evaluate of the predictive properties of clinical scores for functional outcome one year after symptom onset
Time frame: 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
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
Transcriptome analyses
Time frame: one year after symptom onset
Predictive properties of immune parameters in the cerebrovascular fluid for functional outcome one year after symptom onset
Time frame: 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
Quality of life and the occurence of depression and burnout syndrome in relatives
Time frame: one year after symptom onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Meisel, MD principal investigator
Charite University Berlin (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurological Diseases, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.