SepsisNCT02914756
HMGB1 in ICU-survivors
An observational study of Sepsis and Cognitive Impairment, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Is HMGB1 (High Mobility Group Box 1) elevated in sepsis patients for weeks after recovery from severe sepsis/septic shock, similar to what has been observed in mice? Do patients recovering from severe sepsis/septic shock suffer from cognitive impairment and is such impairment associated with prolonged HMGB1 levels in… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sepsis, Cognitive Impairment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- May 2014to Sep 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients being treated at Karolinska University Hospital Intensive Care Unit
Who may be able to join
- Male/Female age 18-17
- Expected ICU-stay more than 24 hours
Who cannot join
- Dont understand the language
- Substance abuse, alcohol or drugs
- Blind, deaf or suffering from aphasia
- Ongoing psychiatric illness or psychopharmacological treatment
- Suffering from dementia och mentally impaired
- Structured brain damage or meningitis
Show all 11Show fewer
- Palliative Care
- ICU-treated for more than 48 hours
- Transferred from other ICU
- Being treated with ECMO
- Not having residency in Stockholm
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital
Stockholm
About this study
Official title: Cognitive Impairment After Critical Illness, Links Between Sepsis, Cognitive Function and Non-resolving Inflammation
Is HMGB1 (High Mobility Group Box 1) elevated in sepsis patients for weeks after recovery from severe sepsis/septic shock, similar to what has been observed in mice? Do patients recovering from severe sepsis/septic shock suffer from cognitive impairment and is such impairment associated with prolonged HMGB1 levels in plasma? Is there a difference from patients recovering from critical illness without prior sepsis?
- Conditions
- Sepsis, Cognitive Impairment
- Medical subject headings
- Sepsis, 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 |
|---|---|---|
| Sepsis | Patients suffering from Severe sepsis or Septic chock at the ICU. | |
| Non-Sepsis | Patients being treated at ICU but not suffering from severe sepsis/septic chock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is HMGB1 elevated in sepsis patients for weeks after recovery from severe sepsis/septic shock, similar to what has been observed in mice?
Measured: 2 years
Do patients recovering from severe sepsis/septic shock suffer from cognitive impairment and is such impairment associated with prolonged HMGB1 levels in plasma? Is there a difference from patients recovering from critical illness without prior sepsis?
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startMay 2014
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Karolinska 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Sackey, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914756
- Sponsor's protocol ID
- EPN 2013/1221-31/1
- Status last verified
- Apr 2019
- First submitted
- 22 Sep 2016
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Bruck E, Svensson-Raskh A, Larsson JW, Caravaca AS, Gallina AL, Eberhardson M, Sackey PV, Olofsson PS. Plasma HMGB1 levels and physical performance in ICU survivors. Acta Anaesthesiol Scand. 2021 Aug;65(7):921-927. doi: 10.1111/aas.13815. Epub 2021 Mar 27.
PubMed 33725363
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impairment After Critical Illness, Links Between Sepsis, Cognitive Function and Non-resolving Inflammation
- ClinicalTrials.gov ID
- NCT02914756
- Acronym / sponsor ID
- EPN 2013/1221-31/1
- Conditions
- Sepsis, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 26 Sep 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.
Is HMGB1 (High Mobility Group Box 1) elevated in sepsis patients for weeks after recovery from severe sepsis/septic shock, similar to what has been observed in mice? Do patients recovering from severe sepsis/septic shock suffer from cognitive impairment and is such impairment associated with prolonged HMGB1 levels in plasma? Is there a difference from patients recovering from critical illness without prior sepsis?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | –Patients suffering from Severe sepsis or Septic chock at the ICU. |
| Non-Sepsis | – | –Patients being treated at ICU but not suffering from severe sepsis/septic chock |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being treated at Karolinska University Hospital Intensive Care Unit
Key inclusion criteria (2 listed)
- Male/Female age 18-17
- Expected ICU-stay more than 24 hours
Key exclusion criteria (11 listed)
- Dont understand the language
- Substance abuse, alcohol or drugs
- Blind, deaf or suffering from aphasia
- Ongoing psychiatric illness or psychopharmacological treatment
- Suffering from dementia och mentally impaired
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
Is HMGB1 elevated in sepsis patients for weeks after recovery from severe sepsis/septic shock, similar to what has been observed in mice?
Time frame: 2 years
Do patients recovering from severe sepsis/septic shock suffer from cognitive impairment and is such impairment associated with prolonged HMGB1 levels in plasma? Is there a difference from patients recovering from critical illness without prior sepsis?
Time frame: 4 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 12 Apr 2019.
- Derived from this study: PubMed 33725363Bruck E, Svensson-Raskh A, Larsson JW, Caravaca AS, Gallina AL, Eberhardson M, Sackey PV, Olofsson PS. Plasma HMGB1 levels and physical performance in ICU survivors. Acta Anaesthesiol Scand. 2021 Aug;65(7):921-927. doi: 10.1111/aas.13815. Epub 2021 Mar 27.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sepsis and Cognitive Impairment, run by Karolinska 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 2 inclusion and 11 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 12 Apr 2019. 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?
Is HMGB1 elevated in sepsis patients for weeks after recovery from severe sepsis/septic shock, similar to what has been observed in mice? (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02914756, which also lists 1 linked publication.
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 12 Apr 2019.