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OpenTrials
Completed

NCT Number: NCT02914756

HMGB1 in ICU-survivors

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?

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Key information

Conditions

Sepsis Cognition Disorders Cognitive Dysfunction Cognitive Impairment Infections Inflammation Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 26, 2016
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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