Neuro-intensive Care Unit PatientsEpiNICNCT07052656
Risk Factors and Outcomes in Patients Treated in Neurocritical Care
An observational study of Neuro-intensive Care Unit Patients and Subarachnoid Hemorrhage, Aneurysmal, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The overall purpose of this epidemiologic research project is to provide a comprehensive exploration and analysis of critical elements within the neuro-intensive care process in Sweden. All aspects of intensive care management in critically ill patients with acute brain injury will be addressed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuro-intensive Care Unit Patients, Subarachnoid Hemorrhage, Aneurysmal, Ischemic Stroke
- What is being tested?
- Observational study, participants are not assigned an intervention as part of the study. and Transport modality
- How many people
- 70,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2010to 31 Dec 2024
- How long will I take part?
- 2 Years
- 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: All patients 18 years or older treated in an ICU in Sweden with a clinical diagnosis of subarachnoid hemorrhage, intracranial hemorrhage, ischemic brain injury, traumatic brain injury, epilepsy, meningitis, encefalitis or other brain injury diagnosis from 2010 to 2024.
Who may be able to join
- ICU admission 2010 to 2024
- Clinical diagnosis of subarachnoid hemorrhage, intracranial hemorrhage or ischemic brain injury, traumatic brain injury, epilepsy, meningitis, encefalititis or other brain injury diagnosis.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The overall purpose of this epidemiologic research project is to provide a comprehensive exploration and analysis of critical elements within the neuro-intensive care process in Sweden. All aspects of intensive care management in critically ill patients with acute brain injury will be addressed. The analyses include description of patient characteristics, intensive care data, management and treatments, various aspects of short and long-term follow-up, mortality, regional- and sex-related differences. The long-term goal is to develop neuro-intensive care and management, to minimize in-hospital insults and secondary injuries, to improve diagnostics and follow-up, in order to reduce prolonged neurologic deficits and mortality in these patients.
- Conditions
- Neuro-intensive Care Unit Patients, Subarachnoid Hemorrhage, Aneurysmal, Ischemic Stroke, Intracerebral Hemorrhage, Stroke, Acute, Meningitis
- Being tested
- Observational study, participants are not assigned an intervention as part of the study., Transport modality
- Medical subject headings
- Subarachnoid Hemorrhage, Ischemic Stroke, Cerebral Hemorrhage, Stroke, Meningitis, Epilepsy, Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study, participants are not assigned an intervention as part of the study.Other
Observational study, participants are not assigned an intervention as part of the study.
Transport modalityOther
Transfer modality to tertiary centers
| Study group | Role | What they receive |
|---|---|---|
| Neuro-intensive care patients | Not described Receives: Other: Observational study, participants are not assigned an intervention as part of the study.; Other: Transport modality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality
Measured: Up to two years
Secondary outcomes (1)
Morbidity
Neuropsychiatric diagnoses, depression/anxiety), longterm sick leave, loss of income as a proxy for quality of life
Measured: Up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start1 Jan 2010
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuro-intensive Care Unit PatientsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- 70,000 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Linn Hallqvist, Karolinska Institutet
- Investigators
- Linn Hallqvist, MD, PhD, Principal investigator, Dep of Perioperative Medicine and Intensive care, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052656
- Sponsor's protocol ID
- K2022-6426
- Other IDs
- KI: 4-1998/2022
- Acronym
- EpiNIC
- Status last verified
- Jul 2025
- First submitted
- 28 May 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Outcomes in Patients Treated in Neurocritical Care
- ClinicalTrials.gov ID
- NCT07052656
- Acronym / sponsor ID
- EpiNIC / K2022-6426
- Conditions
- Neuro-intensive Care Unit Patients, Subarachnoid Hemorrhage, Aneurysmal, Ischemic Stroke, Intracerebral Hemorrhage, Stroke, Acute, Meningitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70,000 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 4 Jul 2025 (actual)
- 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.
The overall purpose of this epidemiologic research project is to provide a comprehensive exploration and analysis of critical elements within the neuro-intensive care process in Sweden. All aspects of intensive care management in critically ill patients with acute brain injury will be addressed. The analyses include description of patient characteristics, intensive care data, management and treatments, various aspects of short and long-term follow-up, mortality, regional- and sex-related differences. The long-term goal is to develop neuro-intensive care and management, to minimize in-hospital insults and secondary injuries, to improve diagnostics and follow-up, in order to reduce prolonged neurologic deficits and mortality in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuro-intensive care patients | – | Other: Observational study, participants are not assigned an intervention as part of the study., Other: Transport modality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients 18 years or older treated in an ICU in Sweden with a clinical diagnosis of subarachnoid hemorrhage, intracranial hemorrhage, ischemic brain injury, traumatic brain injury, epilepsy, meningitis, encefalitis or other brain injury diagnosis from 2010 to 2024.
Key inclusion criteria (2 listed)
- ICU admission 2010 to 2024
- Clinical diagnosis of subarachnoid hemorrhage, intracranial hemorrhage or ischemic brain injury, traumatic brain injury, epilepsy, meningitis, encefalititis or other brain injury diagnosis.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study, participants are not assigned an intervention as part of the study.Observational study, participants are not assigned an intervention as part of the study. | Other | Neuro-intensive care patients |
| Transport modalityTransfer modality to tertiary centers | Other | Neuro-intensive care patients |
Primary outcome
Mortality
Time frame: Up to two years
Mortality
1 secondary outcome
Morbidity
Time frame: Up to two years
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 10 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Neuro-intensive Care Unit Patients
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Ventilator Study in the NICU
Neuro-intensive Care Unit Patients
RecruitingObservational study
Emotional and Neutral Sounds for Neurophysiological Prognostic Assessment of Critically Ill Patients With a Disorder of Consciousness
Disorder of Consciousness
RecruitingObservational study
Non Traumatic Neuro-Vascular Diseases Critical Complications : a Prospective Cohort Study
Non Traumatic Acute Brain Injury
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.
Linn Hallqvist, MD, PhD principal investigator
Dep of Perioperative Medicine and Intensive care, Karolinska University Hospital
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 Neuro-intensive Care Unit Patients and Subarachnoid Hemorrhage, Aneurysmal, run by Karolinska Institutet at 1 site in Sweden.
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 2 inclusion and 0 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 10 Jul 2025. 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 Sweden. 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?
Mortality (time frame: Up to two years). 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 10 Jul 2025.