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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02914756
Other study ID # EPN 2013/1221-31/1
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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