Dysautonomia and Systemic Interactions in Traumatic Brain Injury

NCT05515640 | Active Not Recruiting

• 1 other identifier: 2019-5610
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Following brain injury, complex interactions between the nervous system and other organs are frequently encountered. Systemic effects may be induced by dysregulation of the hypothalamic-pituitary-adrenal axis and the autonomic nervous system. This observational study will investigate the link between clinical, physiological and biochemical expressions of dysautonomic reactions and physiological stress, and their relations to sympathetic activation in traumatic brain injury patients treated in the neurointensive care unit.

Conditions

Traumatic Brain Injury; Dysautonomia; Sympathetic; Imbalance; Inflammation, Brain

Outcome Measures

Primary Outcomes (2)

• Skin Conductance Algesimeter

  the Skin Conductance Algometer (MedStorm (R)) as conductance in microvolts and algesimeter index as peaks/second.

  up to one week

• Stress biomarkers

  Cortsol and adrengeric breakdown metabolites

  up to one week in ICU

Secondary Outcomes (1)

• Exploratory hypothesis-generating analysis of interactions/crosstalk between dysautonomia, the hypothalamic-pituitary-adrenal axis and neuroinflammation.

  Collected during ICU stay up to one week.

Other Outcomes (1)

• Extended Glasgow Outcome Scale (EGOS)

  4-6 months

Study Arms (1)

Karolinska Cohort

Observational cohort corresponding to patients treated at the Neurointensive Care Unit, Karolinska University Hospital, Stockholm, Sweden.

Eligibility Criteria

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

Study Population

Adult patients presenting with traumatic brain injury to the neurointensive care units of Karolinska University Hospital, Stockholm, Sweden. The unit is a tertiary center for neurointensive care and cater to regional residents, as well as to to referral cases from a wider geographic area.

You may qualify if:

• Age 18 years or over.
• Patients suffering from TBI, in need of neurocritical care and intracranial pressure measurement

You may not qualify if:

• TBI unlikely to survive five days (as judged by clinical team, such as bilateral fixed and dilated pupils).
• Follow up not possible

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Region Stockholm: collaborator
• Eurostars: collaborator
• Vinnova: collaborator

Study Sites (1)

Perioperative Medicine and Intensive Care, Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma Cerebrospinal fluid Cerebral Microdialysis samples Urine

MeSH Terms

Conditions

Brain Injuries, Traumatic; Autonomic Nervous System Diseases; Encephalitis

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neuroinflammatory Diseases

Study Officials

• David W Nelson, M.D., Ph.D.

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Senior Consultant, Research Group Leader

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: August 25, 2022
• Study Start: August 1, 2019
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)