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Biomarkers in Cerebrospinal Fluid in Critical Care Patients With Delirium (BIO-ICU)

S

Sahlgrenska University Hospital

Status

Unknown

Conditions

Delirium
Cognitive Dysfunction

Study type

Observational

Funder types

Other

Identifiers

NCT02948374
LUA-74202

Details and patient eligibility

About

Critical care patients are at a high risk of developing delirium and impaired cognitive function 3 and 12 months after their ICU stay. In this study the aim is to try to elucidate the pathophysiology behind delirium in the ICU and subsequent development of cognitive dysfunction in ICU survivors.

Biomarkers in cerebrospinal fluid (CSF) will be analysed in patients with and without delirium in the ICU. Samples will also be taken 3 and 12 months after the ICU-stay. CSF will also be obtained in healthy age- and sexmatched controls undergoing surgery.

Full description

Critical care patients are at a high risk of developing delirium, a form of acute brain dysfunction, and may develop impaired cognitive function 3 and 12 months following their ICU stay.

In this study the aim is to try to elucidate the pathophysiology behind delirium in the ICU comparing patients with and without delirium and possible development of cognitive dysfunction in ICU survivors. Neuroinflammatory markers and markers of structural damage in cerebrospinal fluid (CSF) will be analysed in patients with and without delirium assessed with the CAM-ICU (Confusion Assessment Method) test in the ICU. CSF samples will also be taken in ICU-survivors, 3 and 12 months after the ICU-stay. For comparison CSF will be obtained in healthy age- and sexmatched controls undergoing surgery in spinal anesthesia.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients admitted to ICU for acute respiratory, septic and/or circulatory chock

Exclusion criteria

  • Abnormal coagulation
  • Recent exposure to intensive care
  • Patients unable to assess for delirium
  • Patients difficult to follow up
  • Patients expected to live less than 24 hrs
  • Patients with known cognitive dysfunction based on medical records or relatives report
  • Abnormal coagulation

Trial design

80 participants in 2 patient groups

Delirium positive
Description:
Patients with a positive CAM-ICU test
Delirium negative
Description:
Patient without delirium determined with the CAM-ICU test

Trial contacts and locations

1

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Central trial contact

Stefan Lundin, MD, PhD; Christian Rylander, MD, PhD

Data sourced from clinicaltrials.gov

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