Clinical trial NCT02948374: Biomarkers in Cerebrospinal Fluid in Critical Care Patients With Delirium
Official title: Biomarkers in Cerebrospinal Fluid in Critical Care Patients With Delirium
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Delirium
Cognitive Dysfunction
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2016-10-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive care patients

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.

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

Primary outcomes:
measure: Concentration of biomarkers for inflammation and structural damage in the cerebrospinal fluid in patient with or without delirium in the ICU
timeFrame: At Baseline samples of CSF are taken in patients evaluated with CAM-ICU test and with EEG for the presence or absence of delirium
Secondary outcomes:
measure: 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.
timeFrame: 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.
measure: 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.
timeFrame: 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.
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Stefan Lundin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: