HMGB1 in ICU-survivors
Cognitive Impairment After Critical Illness, Links Between Sepsis, Cognitive Function and Non-resolving Inflammation
1 other identifier
observational
100
1 country
1
Brief 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 plasma? Is there a difference from patients recovering from critical illness without prior sepsis?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 22, 2016
CompletedFirst Posted
Study publicly available on registry
September 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedApril 12, 2019
April 1, 2019
4.3 years
September 22, 2016
April 11, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Is HMGB1 elevated in sepsis patients for weeks after recovery from severe sepsis/septic shock, similar to what has been observed in mice?
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?
4 years
Study Arms (2)
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
Eligibility Criteria
Patients being treated at Karolinska University Hospital Intensive Care Unit
You may qualify if:
- Male/Female age 18-17
- Expected ICU-stay more than 24 hours
You may not qualify if:
- 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
- Palliative Care
- ICU-treated for more than 48 hours
- Transferred from other ICU
- Being treated with ECMO
- Not having residency in Stockholm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital
Stockholm, Sweden
Related Publications (1)
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.
PMID: 33725363DERIVED
Biospecimen
Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
September 22, 2016
First Posted
September 26, 2016
Study Start
May 1, 2014
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
April 12, 2019
Record last verified: 2019-04