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Status unknownNCT02948374BIO-ICUUpdated Jan 8, 2018

Biomarkers in Cerebrospinal Fluid in Critical Care Patients With Delirium

An observational study in Delirium and Cognitive Dysfunction, sponsored by Sahlgrenska University Hospital. Status unknown at 1 site in Sweden. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-01-08.

Sponsored by Sahlgrenska University Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 90 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Delirium
  • Cognitive Dysfunction
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In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's planned enrollment of 80 is below the median of 200 across 418 observational studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Sahlgrenska University Hospital is the lead sponsor of 259 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Intensive care patients

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Delirium positive

    Patients with a positive CAM-ICU test

  • Delirium negative

    Patient without delirium determined with the CAM-ICU test

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What researchers measure

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

    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

Secondary outcomes

  1. 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.

    Time frame: 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.

  2. 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.

    Time frame: 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.

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Study locations

1 of 1 sites recruiting
  • Sahlgrenska University Hospital
    Gothenburg, S-413 45, Sweden
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02948374
Lead sponsor
Sahlgrenska University Hospital
Responsible party
Stefan Lundin (Professor, Sahlgrenska University Hospital) — Principal investigator
First posted
Oct 28, 2016
Start date
Oct 2016
Primary completion
Dec 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Jan 8, 2018

Study contacts

Stefan Lundin, MD, PhD
Contact
stefan.lundin@gu.se
+46313428112
Christian Rylander, MD, PhD
Contact
christian.rylander@vgregion.se
+46 31 3421000
Stefan Lundin, MD, PhD
principal investigator · Sahlgrenska University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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