DeliriumBIO-ICUNCT02948374
Biomarkers in Cerebrospinal Fluid in Critical Care Patients With Delirium
An observational study of Delirium and Cognitive Dysfunction, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Critical care patients are at a high risk of developing delirium and impaired cognitive function 3 and 12 months after their ICU stay. In this study the aim is to try to elucidate the pathophysiology behind delirium in the ICU and subsequent development of cognitive dysfunction in ICU survivors. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Delirium, Cognitive Dysfunction
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2016to Dec 2018
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intensive care patients
Who may be able to join
- Patients admitted to ICU for acute respiratory, septic and/or circulatory chock
Who cannot join
- Abnormal coagulation
- Recent exposure to intensive care
- Patients unable to assess for delirium
- Patients difficult to follow up
- Patients expected to live less than 24 hrs
- Patients with known cognitive dysfunction based on medical records or relatives report
- Abnormal coagulation
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, S-413 45
Stefan Lundin, MD PhD, +46 708744379, stefan.lundin@gu.se
Erik Belfrage, MD, +46313421000, erik.belfrage@vgregion.se
About this study
Critical care patients are at a high risk of developing delirium and impaired cognitive function 3 and 12 months after their ICU stay. In this study the aim is to try to elucidate the pathophysiology behind delirium in the ICU and subsequent development of cognitive dysfunction in ICU survivors.
Biomarkers in cerebrospinal fluid (CSF) will be analysed in patients with and without delirium in the ICU. Samples will also be taken 3 and 12 months after the ICU-stay. CSF will also be obtained in healthy age- and sexmatched controls undergoing surgery.
Read the detailed description
Critical care patients are at a high risk of developing delirium, a form of acute brain dysfunction, and may develop impaired cognitive function 3 and 12 months following their ICU stay.
In this study the aim is to try to elucidate the pathophysiology behind delirium in the ICU comparing patients with and without delirium and possible development of cognitive dysfunction in ICU survivors. Neuroinflammatory markers and markers of structural damage in cerebrospinal fluid (CSF) will be analysed in patients with and without delirium assessed with the CAM-ICU (Confusion Assessment Method) test in the ICU. CSF samples will also be taken in ICU-survivors, 3 and 12 months after the ICU-stay. For comparison CSF will be obtained in healthy age- and sexmatched controls undergoing surgery in spinal anesthesia.
- Conditions
- Delirium, Cognitive Dysfunction
- Medical subject headings
- Delirium, Cognitive Dysfunction
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 |
|---|---|---|
| Delirium positive | Patients with a positive CAM-ICU test | |
| Delirium negative | Patient without delirium determined with the CAM-ICU test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of biomarkers for inflammation and structural damage in the cerebrospinal fluid in patient with or without delirium in the ICU
Delirium in the ICU is assessed with the CAM-ICU test and by EEG in patients admitted to the ICU for respiratory failure or circulatory or septic chock
Measured: At Baseline samples of CSF are taken in patients evaluated with CAM-ICU test and with EEG for the presence or absence of delirium
Secondary outcomes (2)
Concentration of neuroinflammatory biomarkers and markers of neural damage in the cerebrospinal fluid in surviving patients with and without cognitive dysfunction 3 months after their ICU stay.
Measured: Three months after the patients have left the intensive care unit samples of CSF will be taken in surviving patients in the Outcome 1 group above.
Concentration of neuroinflammatory biomarkers and markers of neural damage in the cerebrospinal fluid in surviving patients with and without cognitive dysfunction 12 months after their ICU stay.
Measured: Twelve months after the patients have left the intensive care unit samples of CSF will be taken in surviving patients in the Outcome 1 group above.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Lundin, Sahlgrenska University Hospital
- Investigators
- Stefan Lundin, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948374
- Sponsor's protocol ID
- LUA-74202
- Acronym
- BIO-ICU
- Status last verified
- Jan 2018
- First submitted
- 9 Sep 2016
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Cerebrospinal Fluid in Critical Care Patients With Delirium
- ClinicalTrials.gov ID
- NCT02948374
- Acronym / sponsor ID
- BIO-ICU / LUA-74202
- Conditions
- Delirium, Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 28 Oct 2016 (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.
Critical care patients are at a high risk of developing delirium and impaired cognitive function 3 and 12 months after their ICU stay. In this study the aim is to try to elucidate the pathophysiology behind delirium in the ICU and subsequent development of cognitive dysfunction in ICU survivors.
Biomarkers in cerebrospinal fluid (CSF) will be analysed in patients with and without delirium in the ICU. Samples will also be taken 3 and 12 months after the ICU-stay. CSF will also be obtained in healthy age- and sexmatched controls undergoing surgery.
Detailed description
Critical care patients are at a high risk of developing delirium, a form of acute brain dysfunction, and may develop impaired cognitive function 3 and 12 months following their ICU stay.
In this study the aim is to try to elucidate the pathophysiology behind delirium in the ICU comparing patients with and without delirium and possible development of cognitive dysfunction in ICU survivors. Neuroinflammatory markers and markers of structural damage in cerebrospinal fluid (CSF) will be analysed in patients with and without delirium assessed with the CAM-ICU (Confusion Assessment Method) test in the ICU. CSF samples will also be taken in ICU-survivors, 3 and 12 months after the ICU-stay. For comparison CSF will be obtained in healthy age- and sexmatched controls undergoing surgery in spinal anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delirium positive | – | –Patients with a positive CAM-ICU test |
| Delirium negative | – | –Patient without delirium determined with the CAM-ICU test |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care patients
Key inclusion criteria (1 listed)
- Patients admitted to ICU for acute respiratory, septic and/or circulatory chock
Key exclusion criteria (7 listed)
- Abnormal coagulation
- Recent exposure to intensive care
- Patients unable to assess for delirium
- Patients difficult to follow up
- Patients expected to live less than 24 hrs
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
Concentration of biomarkers for inflammation and structural damage in the cerebrospinal fluid in patient with or without delirium in the ICU
Time frame: At Baseline samples of CSF are taken in patients evaluated with CAM-ICU test and with EEG for the presence or absence of delirium
Delirium in the ICU is assessed with the CAM-ICU test and by EEG in patients admitted to the ICU for respiratory failure or circulatory or septic chock
2 secondary outcomes
Concentration of neuroinflammatory biomarkers and markers of neural damage in the cerebrospinal fluid in surviving patients with and without cognitive dysfunction 3 months after their ICU stay.
Time frame: Three months after the patients have left the intensive care unit samples of CSF will be taken in surviving patients in the Outcome 1 group above.
Concentration of neuroinflammatory biomarkers and markers of neural damage in the cerebrospinal fluid in surviving patients with and without cognitive dysfunction 12 months after their ICU stay.
Time frame: Twelve months after the patients have left the intensive care unit samples of CSF will be taken in surviving patients in the Outcome 1 group above.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Stefan Lundin, MD, PhD principal investigator
Sahlgrenska 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 Delirium and Cognitive Dysfunction, run by Sahlgrenska University Hospital 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Jan 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Lundin, MD, PhD (+46313428112, stefan.lundin@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of biomarkers for inflammation and structural damage in the cerebrospinal fluid in patient with or without delirium in the ICU (time frame: At Baseline samples of CSF are taken in patients evaluated with CAM-ICU test and with EEG for the presence or absence of delirium). 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 8 Jan 2018.