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Euthyroid Sick Syndrome (ESS) Effect on Traumatic Brain Injury Patients and Its Relation With GFAP Level (ESS)

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ClinicalTrials.gov Identifier: NCT04806672
Recruitment Status : Not yet recruiting
First Posted : March 19, 2021
Last Update Posted : March 19, 2021
Sponsor:
Information provided by (Responsible Party):
Mohamed Hameed Mohammed, Minia University

Study Description
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Brief Summary:

Euthyroid sick syndrome (ESS) effects on patients suffering from traumatic brain injury (TBI) have received little attention. Moreover, there is limited evidence that serum levels of thyroid-related hormones might influence functional outcome in the acute phase of brain damage. However, the relationship is complex, and the relevance for functional outcome and the question of therapeutic interventions remain the subject of ongoing researches .

Historically, a wide range of brain damage markers have been examined in TBI patients. However, owing to the limited tissue specificity and other concerns, most markers, including neuro-specific enolase and S100B protein, were compromised in routine clinical use .

Glial fibrillary acidic protein (GFAP) was recently reported to have greater prognostic value than other biomarkers in TBI patients as a monomeric intermediate filament protein concentrated in the astroglial cytoskeleton; GFAP is specific to brain tissue and is not routinely found in peripheral blood circulation. However, GFAP is released after astrocyte death, making it an ideal candidate marker for brain injury patients . Several studies have found that the serum levels of GFAP on admission were significantly increased in TBI patients, also a correlation between serum concentrations and the pathological types of brain damage and clinical outcomes were also reported . However, the changes in serum GFAP over time and the associated predictive utility over the acute days post injury are largely unknown.

To study the hypothesis of euthyroid sick syndrome (ESS) traumatic brain injury patients and its relation with GFAP.


Condition or disease
Euthyroid Sick Syndromes in Traumatic Brain Injury Patient and GFAP Level

Detailed Description:

After obtaining the approval of research ethical committee of faculty of medicine ,El-Minia university and taking informed written consent from the participants or their relatives, this prospective cross sectional non randomized observational study will be conducted in emergency ICU of anesthesiology and intensive care department in El-Minia university hospital ,on Patients suffering from isolated moderate to severe traumatic brain injury GCS (12-3) during the period from January2021 to December 2021. Based on inclusion and exclusion criteria, patients who met eligibility criteria, the prognosis and outcome of traumatic brain injury will be observed.

Parameters assessed:

Medical history Glasgow coma scale (GCS) on admission and daily Brain computerized tomography (CT) on admission ,3rd and 5th days Thyroid functions fT3, fT4, TSH and rT3.will be assessed on admission, after24h, 3rd and 7th days.

APACHE II score ("Acute Physiology And Chronic Health Evaluation II ") Which will be assessed in admission day

SOFA score The sequential organ failure assessment score (SOFA score), Which will be assessed every day. Glial fibrillary acidic protein (GFAP). On admission ,1st,3rd and 7th days Mechanical ventilation. Length of ICU Stay. Short term outcome after 28 days.

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Euthyroid Sick Syndrome (ESS)….. Can it Influence Morbidity and Mortality in Moderate to Severe Traumatic Brain Injury Patients or Correlate With Glial Fibrillary Acidic Protein (GFAP) Level.
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Incidence [ Time Frame: 1year ]
    to investigate the incidence of euthyroid sick syndrome (ESS) in traumatic brain injury patients.

  2. morbidity and mortality [ Time Frame: 1year ]
    to investigate the influence of euthyroid sick syndrome (ESS) on morbidity and mortality in traumatic brain injury patients.


Secondary Outcome Measures :
  1. Disease relations [ Time Frame: 1year ]
    to examine if there is any correlation between euthyroid sick syndrome (ESS) and Glial fibrillary acidic protein (GFAP) which is a sensitive biomarker for traumatic brain injury


Biospecimen Retention:   Samples With DNA
Blood sample

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients suffering from isolated moderate to severe traumatic brain injury GCS (12-3) during the period from January 2021 to December 2021
Criteria

Inclusion Criteria:

  • Age : between (18-60) years old.
  • Gender : both males and females.
  • Isolated moderate to severe traumatic brain injury(TBI) GCS (3-12) who is expected to survive for more than 24 hours

Exclusion Criteria:

  • Poly trauma patients.
  • Critically ill patients.
  • Patients with history of endocrinal disturbance involving both hypothalamo-pituitary axis and thyroid gland.
  • Patients receiving antithyroid medication or hormonal replacement like thyroxin and insulin.
  • Pregnant and lactating females.
  • Patients with history neurological or psychiatric disorders.
  • Patients with liver or renal failure.
  • Patients with recent use of amiodarone or β-blockers.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04806672


Contacts
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Contact: Mohamed Mohamed 01019538266 ext 002 mohamedhameed92@gmail.com

Sponsors and Collaborators
Minia University
More Information
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Responsible Party: Mohamed Hameed Mohammed, Assistant lecturer, Minia University
ClinicalTrials.gov Identifier: NCT04806672    
Other Study ID Numbers: 695:12/2020
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Euthyroid Sick Syndromes
Syndrome
Wounds and Injuries
Disease
Pathologic Processes
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Thyroid Diseases
Endocrine System Diseases