Biomarkers in Cerebrospinal Fluid in Critical Care Patients With Delirium

NCT ID: NCT02948374

Last Updated: 2018-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Delirium Cognitive Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Delirium positive

Patients with a positive CAM-ICU test

No interventions assigned to this group

Delirium negative

Patient without delirium determined with the CAM-ICU test

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Stefan Lundin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan Lundin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

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Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Stefan Lundin, MD, PhD

Role: CONTACT

+46313428112

Christian Rylander, MD, PhD

Role: CONTACT

+46 31 3421000

Facility Contacts

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Stefan Lundin, MD PhD

Role: primary

+46 708744379

Erik Belfrage, MD

Role: backup

+46313421000

Other Identifiers

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LUA-74202

Identifier Type: -

Identifier Source: org_study_id

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