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Prevalence of Latent Tuberculosis Infection Among Hemodialysis Patients

NCT07210970 — Not yet recruiting, 200 participants, Sohag University

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Study of The Prevalence of Latent Tuberculosis Infection Among Hemodialysis Patients Using Tuberculin Skin Test at Sohag University Hospital

RegistryNCT07210970
StatusNot yet recruiting
Study typeObservational
Enrollment200 (Estimated)
SponsorSohag University (Other)
ConditionsLatent Tuberculosis Infection, End Stage Renal Disease (ESRD), Hemodialysis
InterventionsTuberculin Skin Test (TST) (Diagnostic test)
Datesstart 2025-12-01 (estimated), primary completion 2026-12-01 (estimated), completion 2027-12-20 (estimated), first posted 2025-10-07, last updated 2025-10-07

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-Summary

This observational cross-sectional study aims to determine the prevalence of latent tuberculosis infection (LTBI) among patients undergoing regular hemodialysis at Sohag University Hospital, using the tuberculin skin test (TST). Identifying the burden of LTBI in this high-risk population will help guide early detection and preventive strategies

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+Detailed description

Patients receiving chronic hemodialysis are at increased risk of developing tuberculosis due to impaired immune function and frequent exposure to healthcare environments. Latent tuberculosis infection (LTBI) is particularly concerning in this population as it may progress to active disease, leading to increased morbidity and mortality. Early detection of LTBI among hemodialysis patients is essential to reduce this risk.

This cross-sectional study will be conducted at Sohag University Hospital. Two step tuberculin skin test (TST) will be administered to eligible adult patients undergoing regular hemodialysis, the first injection sitewill be examined between 48to 72 hours, and if negative, asecond booster injection will be given 1 to 2 weeks later. The prevalence of LTBI will be assessed by calculating the percentage of patients with a positive TST result (induration ≥10 mm ). Secondary analyses will examine associations between TST positivity and demographic or clinical variables, including age, sex, duration of dialysis, and comorbidities. The results are expected to contribute to local data on the burden of LTBI and to support preventive healthcare strategies in this vulnerable group.

+Arms and interventions

ArmTypeInterventionsDescription
Hemodialysis PatientsDiagnostic Test: Tuberculin Skin Test (TST)Adult patients undergoing regular hemodialysis at Sohag University Hospital who will be screened for latent tuberculosis infection.
  • Tuberculin Skin Test (TST) (Diagnostic test): Intradermal injection of 5 unit (0.1 mm) of purified protein derivative (PPD) with measurement of induration after 48-72 hours.

+Outcome measures

Primary outcomes

  • Prevalence of latent tuberculosis infection among hemodialysis patients. [Within 72 hours after TST administration.]: Percentage of patients with positive tuberculin skin test (defined as induration ≥10 mm).

+Eligibility

Sex: All, ages: 18 Years to 100 Years

Inclusion Criteria:

Age ≥ 18 years Patients on regular hemodialysis Able and willing to provide informed consent

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Exclusion Criteria:

* active TB patients

+Investigators

My Notes