Biomarkers in Cerebrospinal Fluid in Critical Care Patients With Delirium

NCT02948374 | Unknown

• 1 other identifier: LUA-74202
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Arms (2)

Delirium positive

Patients with a positive CAM-ICU test

Delirium negative

Patient without delirium determined with the CAM-ICU test

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intensive care patients

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, S-413 45, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cerebrospinal fluid Blood

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Stefan Lundin, MD, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Lundin, MD, PhD

CONTACT

+46313428112; stefan.lundin@gu.se

Christian Rylander, MD, PhD

CONTACT

+46 31 3421000; christian.rylander@vgregion.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: October 28, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 8, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)