Thyroid Profiles in Patients With Acute Illness

February 23, 2025 updated by: Jordan Collaborating Cardiology Group

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

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Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Jordan
      • Amman, Jordan, 11888
        • Istishari Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
GROUP 1: Acute illness and abnormal thyroid function
Patients admitted to the hospital with acute illness and found to have thyroid function abnormalities.
Other: Performing blood thyroid test (TSH, FT4, FT3)
Blood test as above
GROUP 2: Acute illness and normal thyroid function
Patients admitted to the hospital with acute illness and found to have normal thyroid function.
Other: Performing blood thyroid test (TSH, FT4, FT3)
Blood test as above

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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..
From time of study entry until the date of death from any cause, assessed up to 2 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jordan Collaborating Cardiology Group

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DCR2023/1.ThyrAcuteIll

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Will contact other ICU physicians in the city of Amman to invite them to participate in the study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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