Evaluation of Microbial and Endocrinological Parameters in Dialysis Patients With Sepsis

Condition(s) studied

Investigational drug(s) / intervention(s)

Blood cultures will be obtained from three sources: 1. The central venous catheter (CVC), 2. The dialysis machine circuit, and 3. A peripheral vein: PTH levels during sepsis and compare them to baseline pre-infection levels, with serial follow-up of PTH values post-recovery.

Study summary

This prospective study aims to evaluate the diagnostic value and reliability of blood cultures obtained from different sources-central venous catheter (CVC), dialysis machine, and peripheral vein-in hemodialysis patients with suspected catheter-related bloodstream infections (CRBSIs). By comparing the timing and rates of bacterial growth from each site, the study seeks to identify the most accurate and timely method for diagnosing bloodstream infections in this patient population.

In addition, the study will assess the dynamics of parathyroid hormone (PTH) levels during acute infections. Specifically, it will investigate whether a significant drop in PTH levels-and the rate of recovery following infection-correlates with adverse outcomes such as infectious complications, cardiovascular morbidity, or 90-day mortality. These findings may offer valuable prognostic insights and support improved monitoring and treatment strategies for dialysis patients experiencing infection.

Eligibility

Primary outcome measure(s)

• Rate of Positive Blood Cultures by Sampling Site Among Documented Bloodstream Infections (CVC, Dialysis Machine, Peripheral Vein) — Within 21 days of hospitalization
  This outcome measure will compare the proportion of positive blood cultures obtained from three different sampling sites-central venous catheter (CVC), dialysis machine, and peripheral vein-among all confirmed cases of bloodstream infection in dialysis patients. The goal is to evaluate the diagnostic yield of each site and identify the most sensitive and reliable source for detecting bloodstream infections. Findings will support evidence-based recommendations regarding the preferred site for blood culture collection in this population. Comparative analysis will include statistical evaluation of sensitivity, yield, and agreement between sites.
• Change in Parathyroid Hormone (PTH) Levels During Infection and Rate of PTH Recovery Post-Discharge — 90 days post-discharge
  This outcome measure will evaluate the change in parathyroid hormone (PTH) levels during acute infection and the monthly rate of recovery after hospital discharge in dialysis patients. PTH levels will be measured at three time points: (1) during the acute infection, (2) at discharge, and (3) monthly for up to 90 days post-discharge. The primary analysis will assess the magnitude of PTH suppression during infection and the trajectory of recovery over time. These parameters will be analyzed for their correlation with key 90-day outcomes, including infectious complications, cardiovascular events, and all-cause mortality. Statistical analyses will include repeated measures ANOVA and mixed-effects models to evaluate longitudinal changes and their association with clinical endpoints.

Trial sites (1)

More Western Galilee Hospital-Nahariya trials in Israel

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