- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05980923
Thyroid Profiles in Patients With Acute Illness
Thyroid Profiles in Middle Eastern Patients Admitted With Acute Illness: Prevalence, Clinical Features and Impact on Mortality
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Contacts and Locations
Study Locations
-
-
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Amman, Jordan, 11888
- Istishari Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Age less than 18 years.
- Refusal to sign consent.
- Admission for a reason not classified as acute illness.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
GROUP 1: Acute illness and abnormal thyroid function
Patients admitted to the hospital with acute illness and found to have thyroid function abnormalities.
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Blood test as above
|
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GROUP 2: Acute illness and normal thyroid function
Patients admitted to the hospital with acute illness and found to have normal thyroid function.
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Blood test as above
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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..
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From time of study entry until the date of death from any cause, assessed up to 2 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6-month mortality rate
Time Frame: From date of study entry until the date of death from any cause, assessed up to two weeks.
|
All-cause death rate in patients with abnormal thyroid function compared with death in those with no abnormal thyroid function at 6 months.
|
From date of study entry until the date of death from any cause, assessed up to two weeks.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCR2023/1.ThyrAcuteIll
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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