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Clinical Trials/NCT02914756
NCT02914756CompletedNot Applicable

Cognitive Impairment After Critical Illness, Links Between Sepsis, Cognitive Function and Non-resolving Inflammation

Karolinska University Hospital1 site in 1 country100 target enrollmentStarted: May 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Is HMGB1 elevated in sepsis patients for weeks after recovery from severe sepsis/septic shock, similar to what has been observed in mice?

Study Overview

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?

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Male/Female age 18-17
  • Expected ICU-stay more than 24 hours

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Karolinska University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Peter Sackey

MD, PhD

Karolinska University Hospital

Study Sites (1)

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