HMGB1 in ICU-survivors

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02914756
• Other study ID #: EPN 2013/1221-31/1
• Status: Completed
• Start date: May 2014
• Est. completion date: September 2018

Study information

• Verified date: April 2019
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 plasma? Is there a difference from patients recovering from critical illness without prior sepsis?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Sepsis

Locations

Country	Name	City	State
Sweden	Dept of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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