Thyroid Profiles in Patients With Acute Illness

Sponsor
Jordan Collaborating Cardiology Group (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05980923
Collaborator
(none)
500
1
13.6
36.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Performing blood thyroid test (TSH, FT4, FT3)

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

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Thyroid Profiles in Middle Eastern Patients Admitted With Acute Illness: Prevalence, Clinical Features and Impact on Mortality
Anticipated Study Start Date :
Aug 15, 2023
Anticipated Primary Completion Date :
Aug 15, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm 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.

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

Outcome Measures

Primary Outcome Measures

  1. In hospital mortality [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..

Secondary Outcome Measures

  1. 6-month mortality rate [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istishari Hospital Amman Jordan 11888

Sponsors and Collaborators

  • Jordan Collaborating Cardiology Group

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jordan Collaborating Cardiology Group
ClinicalTrials.gov Identifier:
NCT05980923
Other Study ID Numbers:
  • DCR2023/1.ThyrAcuteIll
First Posted:
Aug 8, 2023
Last Update Posted:
Aug 8, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jordan Collaborating Cardiology Group
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 8, 2023