Thyroid AbnormalitiesNCT04313101
Association Between Thyroid Dysfunction and Intensive Care Unit Acquired Weaknesss
An observational study of Thyroid Abnormalities and ICU Acquired Weakness, run by Ain Shams University at 1 site in Egypt.
Trial summary
Intensive care unit-acquired weakness (ICU-AW) is the most common neuromuscular impairment in critically ill patients. It affects more than 50 % of patients in the intensive care and is related to many problems as difficult weaning from mechanical ventilation, prolonged hospital stay and increased mortality.Thyroid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Abnormalities, ICU Acquired Weakness
- What is being tested?
- withdrawl of blood samples for thyroid function testing
- How many people
- 114 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2020to May 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinical criteria for Intensive care unit acquired weakness : 1. . Weakness developing after the onset of critical illness 2. . Generalized (Proximal and distal), symmetrical and flaccid weakness with sparing of cranial nerves 3. . MRC) score< 48 (or mean score <4 in all tested muscles on more than two occasions more than 24 hours apart) . 4. . Mechanical ventilator dependence 5. . Cause of weakness not related directly to the underlying critical illness * Final Diagnosis of ICUAW : 1. Presence of criteria (1), (2) and (5) + (3) Or (4) 2. Results of Nerve conduction studies Nerve conduction studies :Unilateral bedside nerve conduction tests of the sural and peroneal nerves (reduced CMAP amplitudes).
Who may be able to join
- Patients of both sexes admitted to the general ICU of Ain Shams University Hospitals with critical illness for more than 7 days * Diagnosis of ICU acquired weakness will be made based on clinical criteria for ICUAW and confirmed by nerve conduction studies.
Who cannot join
- Patients with cerebrovascular accidents, neuromuscular disorders, spine abnormalities, spinal cord or head injuries, CNS tumors, secondary thyroid disorders and electrolyte disturbances were excluded from the study. Patients receiving thyroid replacement or anti-thyroid drugs for the treatment of any throid disorder will be also excluded from the study as these drugs may alter their thyroid biochemistry
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University hospitals
Cairo, Abbaseya, 11566
About this study
Official title: Association Between Thyroid Dysfunction and Intensive Care Unit Acquired Weakness: A Case Control Study
Intensive care unit-acquired weakness (ICU-AW) is the most common neuromuscular impairment in critically ill patients. It affects more than 50 % of patients in the intensive care and is related to many problems as difficult weaning from mechanical ventilation, prolonged hospital stay and increased mortality.Thyroid disorders are also associated with neuromuscular abnormalities and may decrease the threshold for the development of any type of myopathy. However, no previous study investigated the direct relationship between thyroid dysfunction and ICUAW.This study aims at evaluation of the association between thyroid dysfunction and intensive care unit acquired weakness.
Read the detailed description
Intensive care unit acquired weakness refers to muscle weakness encountered in the intensive care unit as a consequence of critical illness. It affects more than 50 % of patients in the intensive care and is related to many problems as difficult weaning from mechanical ventilation, prolonged hospital stay and increased mortality.
There are three distinct entities for ICUAW that can only be differentiated by neurophysiological studies. These are critical illness myopathy (CIM), critical illness polyneuropathy (CIP) and critical illness neuromyopathy (CINM).
Identification of risk factors responsible for the development of ICUAW is the first step in the prevention and management of this disorder. Till time septic shock, hyperglycemia, high dose steroid therapy, prolonged mechanical ventilation and the use of neuromuscular blocking agents are the main accused.
Thyroid disorders are also associated with neuromuscular abnormalities. Unfortunately, the prevalence of thyroid dysfunction in the intensive care is high reaching 90%. Moreover, patients with severe critical illness, who are typically prone to the development of ICUAW, show changes in their thyroid biochemistry namely low T3 levels (with or without low T4 levels) in the presence of normal TSH levels. These changes are collectively known as Non-Thyroidal illness syndrome (previously low T3 syndrome and Euthyroid sick syndrome) which is the most common form of thyroid dysfunction in the intensive care unit.
- Conditions
- Thyroid Abnormalities, ICU Acquired Weakness
- Being tested
- withdrawl of blood samples for thyroid function testing
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
withdrawl of blood samples for thyroid function testingOther
Blood samples will be withdrawn from patients admitted to the intensive care for more than 7 days to measure Thyroid hormones (Free T3: Tri-iodothyronine and Free T4:thyroxine) and TSH ( Thyroid Stimulating Hormone) using ELISA kits. Reference ranges will be as follows: TSH 0.4-4mU/L, Free T3 2-4.4 mU/L, Free T4 0.8-1.9 mU/L. Patients will be then categorized into one of the following categories
- Euthyroid ( Normal TSH, FT3 and FT4)
- Hyperthyroid (Low TSH) either overt (increased FT3 and /or FT4) or subclinical (normal FT4 and FT3).
- Hypothyroid (Elevated TSH) either overt (Low FT3 and FT4) or subclinical (Normal FT3 and FT4)
- Non-thyroidal illness syndrome : normal or low TSH in addition to low FT3 ± Low FT4 levels.
| Study group | Role | What they receive |
|---|---|---|
| Cases (ICUAW) | 57 critically ill patients developing ICUAW during their stay in the intensive care unit will be included in the study as cases. Receives: Other: withdrawl of blood samples for thyroid function testing | |
| Controls | A total of 57 Critically ill patients in the same period who did not develop ICU acquired weakness during their ICU stay will be included as controls. Receives: Other: withdrawl of blood samples for thyroid function testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between thyroid dysfunction and ICUAW
Comparison between both groups as regards thyroid functions and the incidence of each of the four categories of thyroid function.Logistic regression will be done to assess each of the four categories of thyroid function as a risk factor in the development of ICUAW in the presence of other risk factors.
Measured: Patients admitted to the intensive care for more than 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start20 Feb 2020
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid AbnormalitiesStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Samir Shabana, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313101
- Sponsor's protocol ID
- FMASU R 10/2020
- Status last verified
- Mar 2020
- First submitted
- 16 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Thyroid Dysfunction and Intensive Care Unit Acquired Weakness: A Case Control Study
- ClinicalTrials.gov ID
- NCT04313101
- Acronym / sponsor ID
- FMASU R 10/2020
- Conditions
- Thyroid Abnormalities, ICU Acquired Weakness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 18 Mar 2020 (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.
Intensive care unit-acquired weakness (ICU-AW) is the most common neuromuscular impairment in critically ill patients. It affects more than 50 % of patients in the intensive care and is related to many problems as difficult weaning from mechanical ventilation, prolonged hospital stay and increased mortality.Thyroid disorders are also associated with neuromuscular abnormalities and may decrease the threshold for the development of any type of myopathy. However, no previous study investigated the direct relationship between thyroid dysfunction and ICUAW.This study aims at evaluation of the association between thyroid dysfunction and intensive care unit acquired weakness.
Detailed description
Intensive care unit acquired weakness refers to muscle weakness encountered in the intensive care unit as a consequence of critical illness. It affects more than 50 % of patients in the intensive care and is related to many problems as difficult weaning from mechanical ventilation, prolonged hospital stay and increased mortality.
There are three distinct entities for ICUAW that can only be differentiated by neurophysiological studies. These are critical illness myopathy (CIM), critical illness polyneuropathy (CIP) and critical illness neuromyopathy (CINM).
Identification of risk factors responsible for the development of ICUAW is the first step in the prevention and management of this disorder. Till time septic shock, hyperglycemia, high dose steroid therapy, prolonged mechanical ventilation and the use of neuromuscular blocking agents are the main accused.
Thyroid disorders are also associated with neuromuscular abnormalities. Unfortunately, the prevalence of thyroid dysfunction in the intensive care is high reaching 90%. Moreover, patients with severe critical illness, who are typically prone to the development of ICUAW, show changes in their thyroid biochemistry namely low T3 levels (with or without low T4 levels) in the presence of normal TSH levels. These changes are collectively known as Non-Thyroidal illness syndrome (previously low T3 syndrome and Euthyroid sick syndrome) which is the most common form of thyroid dysfunction in the intensive care unit.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases (ICUAW) | – | Other: withdrawl of blood samples for thyroid function testing57 critically ill patients developing ICUAW during their stay in the intensive care unit will be included in the study as cases. |
| Controls | – | Other: withdrawl of blood samples for thyroid function testingA total of 57 Critically ill patients in the same period who did not develop ICU acquired weakness during their ICU stay will be included as controls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical criteria for Intensive care unit acquired weakness : 1. . Weakness developing after the onset of critical illness 2. . Generalized (Proximal and distal), symmetrical and flaccid weakness with sparing of cranial nerves 3. . MRC) score< 48 (or mean score <4 in all tested muscles on more than two occasions more than 24 hours apart) . 4. . Mechanical ventilator dependence 5. . Cause of weakness not related directly to the underlying critical illness * Final Diagnosis of ICUAW : 1. Presence of criteria (1), (2) and (5) + (3) Or (4) 2. Results of Nerve conduction studies Nerve conduction studies :Unilateral bedside nerve conduction tests of the sural and peroneal nerves (reduced CMAP amplitudes).
Key inclusion criteria (1 listed)
- Patients of both sexes admitted to the general ICU of Ain Shams University Hospitals with critical illness for more than 7 days * Diagnosis of ICU acquired weakness will be made based on clinical criteria for ICUAW and confirmed by nerve conduction studies.
Key exclusion criteria (1 listed)
- Patients with cerebrovascular accidents, neuromuscular disorders, spine abnormalities, spinal cord or head injuries, CNS tumors, secondary thyroid disorders and electrolyte disturbances were excluded from the study. Patients receiving thyroid replacement or anti-thyroid drugs for the treatment of any throid disorder will be also excluded from the study as these drugs may alter their thyroid biochemistry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| withdrawl of blood samples for thyroid function testingBlood samples will be withdrawn from patients admitted to the intensive care for more than 7 days to measure Thyroid hormones (Free T3: Tri-iodothyronine and Free T4:thyroxine) and TSH ( Thyroid Stimulating Hormone) using ELISA kits. Reference ranges will be as follows: TSH 0.4-4mU/L, Free T3 2-4.4 mU/L, Free T4 0.8-1.9 mU/L. Patients will be then categorized into one of the following categories * Euthyroid ( Normal TSH, FT3 and FT4) * Hyperthyroid (Low TSH) either overt (increased FT3 and /or FT4) or subclinical (normal FT4 and FT3). * Hypothyroid (Elevated TSH) either overt (Low FT3 and FT4) or subclinical (Normal FT3 and FT4) * Non-thyroidal illness syndrome : normal or low TSH in addition to low FT3 ± Low FT4 levels. | Other | Cases (ICUAW), Controls |
Primary outcome
Association between thyroid dysfunction and ICUAW
Time frame: Patients admitted to the intensive care for more than 7 days
Comparison between both groups as regards thyroid functions and the incidence of each of the four categories of thyroid function.Logistic regression will be done to assess each of the four categories of thyroid function as a risk factor in the development of ICUAW in the presence of other risk factors.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Abnormalities and ICU Acquired Weakness, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 1 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 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Tarek S Shabana, MD (01001594109 ext. +20, tarek.shabana@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between thyroid dysfunction and ICUAW (time frame: Patients admitted to the intensive care for more than 7 days). 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 18 Mar 2020.