Biomarkers in Cerebrospinal Fluid in Critical Care Patients With Delirium

Delirium Clinical Trial

— BIO-ICU  

Official title:

Biomarkers in Cerebrospinal Fluid in Critical Care Patients With Delirium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02948374
• Other study ID #: LUA-74202
• Status: Recruiting
• Phase: N/A
• First received: September 9, 2016
• Last updated: January 5, 2018
• Start date: October 2016
• Est. completion date: December 2018

Study information

• Verified date: January 2018
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Stefan Lundin, MD, PhD
• Phone: +46313428112
• Email: stefan.lundin[@]gu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Delirium

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of biomarkers for inflammation and structural damage in the cerebrospinal fluid in patient with or without delirium in the ICU	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	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	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.
Secondary	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.