Euthyroid Sick Syndromes in Traumatic Brain Injury Patient and GFAP LevelESSNCT04806672
Euthyroid Sick Syndrome (ESS) Effect on Traumatic Brain Injury Patients and Its Relation With GFAP Level
An observational study of Euthyroid Sick Syndromes in Traumatic Brain Injury Patient and GFAP Level, run by Minia University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Euthyroid Sick Syndromes in Traumatic Brain Injury Patient and GFAP Level
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients suffering from isolated moderate to severe traumatic brain injury GCS (12-3) during the period from January 2021 to December 2021
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
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 .
Read more
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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence
to investigate the incidence of euthyroid sick syndrome (ESS) in traumatic brain injury patients.
Measured: 1year
morbidity and mortality
to investigate the influence of euthyroid sick syndrome (ESS) on morbidity and mortality in traumatic brain injury patients.
Measured: 1year
Secondary outcomes (1)
Disease relations
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
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 Sep 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Euthyroid Sick Syndromes in Traumatic Brain Injury Patient and GFAP LevelStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hameed Mohammed, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806672
- Sponsor's protocol ID
- 695:12/2020
- Acronym
- ESS
- Status last verified
- Aug 2022
- First submitted
- 14 Mar 2021
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04806672
- Acronym / sponsor ID
- ESS / 695:12/2020
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients suffering from isolated moderate to severe traumatic brain injury GCS (12-3) during the period from January 2021 to December 2021
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence
Time frame: 1year
to investigate the incidence of euthyroid sick syndrome (ESS) in traumatic brain injury patients.
morbidity and mortality
Time frame: 1year
to investigate the influence of euthyroid sick syndrome (ESS) on morbidity and mortality in traumatic brain injury patients.
1 secondary outcome
Disease relations
Time frame: 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Euthyroid Sick Syndromes in Traumatic Brain Injury Patient and GFAP Level, run by Minia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Mohamed (01019538266 ext. 002, mohamedhameed92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (time frame: 1year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.