About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Hemodialysis patients over the age of 18 who are hospitalized at the Galilee Medical Center due to sepsis and have provided written informed consent to participate in this study.
Trial design
Case-only
Prospective
Treatments tested in this trial
Blood cultures will be obtained from three sources: 1. The central venous catheter (CVC), 2. The dialysis machine circuit, and 3. A peripheral vein
Diagnostic testPTH levels during sepsis and compare them to baseline pre-infection levels, with serial follow-up of PTH values post-recovery.
Treatment groups
Trial outcomes
Primary outcomes
Rate of Positive Blood Cultures by Sampling Site Among Documented Bloodstream Infections (CVC, Dialysis Machine, Peripheral Vein)
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
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.
Secondary outcomes
Rate of Recurrent Infections Within 90 Days of Hospital Discharge
This secondary outcome will assess the rate of recurrent infections occurring within 90 days of hospital discharge among dialysis patients who experienced an initial infectious episode. The analysis will examine whether the magnitude of PTH suppression during infection and the rate of PTH recovery post-discharge are associated with the risk of recurrent infection. Recurrent infections will be defined based on clinical and microbiological criteria. Statistical analysis will include logistic regression and time-to-event models.
Incidence of Cardiovascular Events Within 90 Days of Hospital Discharge
This secondary outcome will assess the incidence of cardiovascular events occurring within 90 days of discharge among dialysis patients following an infectious episode. The analysis will explore whether the degree of parathyroid hormone (PTH) suppression during infection and the rate of PTH recovery are associated with cardiovascular risk. Cardiovascular events will include acute coronary syndrome, arrhythmia, stroke, and heart failure exacerbation, confirmed by clinical documentation. Statistical models such as Cox proportional hazards or logistic regression will be used to evaluate associations.
All-Cause Mortality Within 180 Days of Hospital Discharge.
This secondary outcome will evaluate all-cause mortality within 180 days following hospital discharge in dialysis patients who experienced an infectious episode. The analysis will investigate whether the extent of parathyroid hormone (PTH) suppression during infection and the rate of PTH recovery post-discharge are associated with mortality risk. Deaths will be confirmed through clinical records or national registries. Cox proportional hazards models will be used to assess the relationship between PTH dynamics and mortality.
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