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Clinical Trials/NCT02948374
NCT02948374
Unknown
N/A

Biomarkers in Cerebrospinal Fluid in Critical Care Patients With Delirium

Sahlgrenska University Hospital, Sweden1 site in 1 country80 target enrollmentOctober 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Delirium
Sponsor
Sahlgrenska University Hospital, Sweden
Enrollment
80
Locations
1
Primary Endpoint
Concentration of biomarkers for inflammation and structural damage in the cerebrospinal fluid in patient with or without delirium in the ICU
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
December 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sahlgrenska University Hospital, Sweden
Responsible Party
Principal Investigator
Principal Investigator

Stefan Lundin

Professor

Sahlgrenska University Hospital, Sweden

Eligibility Criteria

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

Outcomes

Primary Outcomes

Concentration of biomarkers for inflammation and structural damage in the cerebrospinal fluid in patient with or without delirium in the ICU

Time Frame: At Baseline samples of CSF are taken in patients evaluated with CAM-ICU test and with EEG for the presence or absence of delirium

Delirium in the ICU is assessed with the CAM-ICU test and by EEG in patients admitted to the ICU for respiratory failure or circulatory or septic chock

Secondary Outcomes

  • Concentration of neuroinflammatory biomarkers and markers of neural damage in the cerebrospinal fluid in surviving patients with and without cognitive dysfunction 3 months after their ICU stay.(Three months after the patients have left the intensive care unit samples of CSF will be taken in surviving patients in the Outcome 1 group above.)
  • Concentration of neuroinflammatory biomarkers and markers of neural damage in the cerebrospinal fluid in surviving patients with and without cognitive dysfunction 12 months after their ICU stay.(Twelve months after the patients have left the intensive care unit samples of CSF will be taken in surviving patients in the Outcome 1 group above.)

Study Sites (1)

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