Thyroid DysfunctionNCT05980923
Thyroid Profiles in Patients With Acute Illness
An observational study of Thyroid Dysfunction and Acute Illness, run by Jordan Collaborating Cardiology Group at 1 site in Jordan.
Trial summary
Patients admitted to the hospital with acute illness may have a wide spectrum of thyroid function abnormalities. It is largely unknown whether such aberrations are temporary or persist for a long time, and whether they impact prognosis of such patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Dysfunction, Acute Illness
- What is being tested?
- Performing blood thyroid test (TSH, FT4, FT3)
- How many people
- 0 participants
- Where
- 1 siteJordan
- Study dates
- 15 Oct 2023to 30 Jan 2025
- 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
- Adult, Older adult
Study population: nclusion Criteria: All patients admitted to the hospital with acute illness will have their serum level of thyroid stimulating hormone and free T4 and T3 measured on admission. Clinical and laboratory profiles of patients with abnormal thyroid function (Group 1) will be compared to those with normal thyroid function (Group 2). Serum thyroid test will be repeated at 6 months. Short and long term survival of both groups will be compared as well. Diagnosis on admission is acute illness includes: heart failure, acute coronary syndrome, sepsis, acute stroke, hypotension, acute system-organ failure including renal and hepatic failure.
Who may be able to join
- Hospital admission
- Adults aged 18 years and above
- Willing to sign an informed consent
- Diagnosis on admission is acute illness that includes: heart failure, acute coronary syndrome, sepsis, acute stroke, hypotension, acute system-organ failure including renal and hepatic failure.
Who cannot join
- Age less than 18 years.
- Refusal to sign consent.
- Admission for a reason not classified as acute illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thyroid Profiles in Middle Eastern Patients Admitted With Acute Illness: Prevalence, Clinical Features and Impact on Mortality
Patients admitted to the hospital with acute illness may have a wide spectrum of thyroid function abnormalities. It is largely unknown whether such aberrations are temporary or persist for a long time, and whether they impact prognosis of such patients.
Read the detailed description
Recently, there has been a growing body of evidence that subclinical thyroid dysfunction as a contributor to the increase of cardiovascular events. Elevated serum thyroid-stimulating hormone (TSH) levels and normal free thyroxine (FT4) and free triiodothyronine (FT3) levels have been associated with worse heart failure and dyslipidemia. Furthermore, higher risk of atrial fibrillation has been linked tp thyroid abnormalities in these patients.
Patients admitted to the hospital with acute illness may have a wide spectrum of thyroid function abnormalities. It is largely unknown whether such aberrations are temporary or persist for a long time, and whether they impact prognosis of such patients. This study aimed at evaluating the prevalence of thyroid function abnormalities in patients admitted to hospital with acute illness and their temporal changes and impact on mortality during hospitalization and at 1 year. Serum level of thyroid stimulating hormone and free T4 and T3 measured on admission. Clinical and laboratory profiles of patients with abnormal thyroid function (ATF group) will be compared to those with normal thyroid function (NTF group). Short and long term survival of both groups were compares as well.
- Conditions
- Thyroid Dysfunction, Acute Illness
- Being tested
- Performing blood thyroid test (TSH, FT4, FT3)
- Keywords
- Thyroid abnormalities, Acute illness, Prognosis, Middle east
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performing blood thyroid test (TSH, FT4, FT3)Other
Blood test as above
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1: Acute illness and abnormal thyroid function | Patients admitted to the hospital with acute illness and found to have thyroid function abnormalities. Receives: Other: Performing blood thyroid test (TSH, FT4, FT3) | |
| GROUP 2: Acute illness and normal thyroid function | Patients admitted to the hospital with acute illness and found to have normal thyroid function. Receives: Other: Performing blood thyroid test (TSH, FT4, FT3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
In hospital mortality
All-cause death rate in patients with abnormal thyroid function compared with death in those with no abnormal thyroid function during the patients hospital stay..
Measured: From time of study entry until the date of death from any cause, assessed up to 2 weeks.
Secondary outcomes (1)
6-month mortality rate
All-cause death rate in patients with abnormal thyroid function compared with death in those with no abnormal thyroid function at 6 months.
Measured: From date of study entry until the date of death from any cause, assessed up to two weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start15 Oct 2023
- Primary completion15 Jan 2025
- Study completion30 Jan 2025
Why it stopped: no funds for TSH testing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DysfunctionStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan Collaborating Cardiology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980923
- Sponsor's protocol ID
- DCR2023/1.ThyrAcuteIll
- Status last verified
- Feb 2025
- First submitted
- 20 Jul 2023
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will contact other ICU physicians in the city of Amman to invite them to participate in the study
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Profiles in Middle Eastern Patients Admitted With Acute Illness: Prevalence, Clinical Features and Impact on Mortality
- ClinicalTrials.gov ID
- NCT05980923
- Acronym / sponsor ID
- DCR2023/1.ThyrAcuteIll
- Conditions
- Thyroid Dysfunction, Acute Illness
- Keywords
- Thyroid abnormalities, Acute illness, Prognosis, Middle east
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no funds for TSH testing
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jordan Collaborating Cardiology GroupUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 8 Aug 2023 (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.
Patients admitted to the hospital with acute illness may have a wide spectrum of thyroid function abnormalities. It is largely unknown whether such aberrations are temporary or persist for a long time, and whether they impact prognosis of such patients.
Detailed description
Recently, there has been a growing body of evidence that subclinical thyroid dysfunction as a contributor to the increase of cardiovascular events. Elevated serum thyroid-stimulating hormone (TSH) levels and normal free thyroxine (FT4) and free triiodothyronine (FT3) levels have been associated with worse heart failure and dyslipidemia. Furthermore, higher risk of atrial fibrillation has been linked tp thyroid abnormalities in these patients.
Patients admitted to the hospital with acute illness may have a wide spectrum of thyroid function abnormalities. It is largely unknown whether such aberrations are temporary or persist for a long time, and whether they impact prognosis of such patients. This study aimed at evaluating the prevalence of thyroid function abnormalities in patients admitted to hospital with acute illness and their temporal changes and impact on mortality during hospitalization and at 1 year. Serum level of thyroid stimulating hormone and free T4 and T3 measured on admission. Clinical and laboratory profiles of patients with abnormal thyroid function (ATF group) will be compared to those with normal thyroid function (NTF group). Short and long term survival of both groups were compares as well.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP 1: Acute illness and abnormal thyroid function | – | Other: Performing blood thyroid test (TSH, FT4, FT3)Patients admitted to the hospital with acute illness and found to have thyroid function abnormalities. |
| GROUP 2: Acute illness and normal thyroid function | – | Other: Performing blood thyroid test (TSH, FT4, FT3)Patients admitted to the hospital with acute illness and found to have normal thyroid function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- nclusion Criteria: All patients admitted to the hospital with acute illness will have their serum level of thyroid stimulating hormone and free T4 and T3 measured on admission. Clinical and laboratory profiles of patients with abnormal thyroid function (Group 1) will be compared to those with normal thyroid function (Group 2). Serum thyroid test will be repeated at 6 months. Short and long term survival of both groups will be compared as well. Diagnosis on admission is acute illness includes: heart failure, acute coronary syndrome, sepsis, acute stroke, hypotension, acute system-organ failure including renal and hepatic failure.
Key inclusion criteria (4 listed)
- Hospital admission
- Adults aged 18 years and above
- Willing to sign an informed consent
- Diagnosis on admission is acute illness that includes: heart failure, acute coronary syndrome, sepsis, acute stroke, hypotension, acute system-organ failure including renal and hepatic failure.
Key exclusion criteria (3 listed)
- Age less than 18 years.
- Refusal to sign consent.
- Admission for a reason not classified as acute illness.
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 |
|---|---|---|
| Performing blood thyroid test (TSH, FT4, FT3)Blood test as above | Other | GROUP 1: Acute illness and abnormal thyroid function, GROUP 2: Acute illness and normal thyroid function |
Primary outcome
In hospital mortality
Time frame: From time of study entry until the date of death from any cause, assessed up to 2 weeks.
All-cause death rate in patients with abnormal thyroid function compared with death in those with no abnormal thyroid function during the patients hospital stay..
1 secondary outcome
6-month mortality rate
Time frame: From date of study entry until the date of death from any cause, assessed up to two weeks.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: Undecided. Will contact other ICU physicians in the city of Amman to invite them to participate in the study
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dysfunction and Acute Illness, run by Jordan Collaborating Cardiology Group at 1 site in Jordan.
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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 25 Feb 2025. 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 Jordan. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In hospital mortality (time frame: From time of study entry until the date of death from any cause, assessed up to 2 weeks.). 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 25 Feb 2025.