Evaluation of Microbial and Endocrinological Parameters in Dialysis Patients With Sepsis

NCT06963853 | Recruiting DMC

• 1 other identifier: 0086-22-NHR
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis; Hemodialysis

Keywords

blood cultures; parathyroid hormone; catheter; infection; cardiovascular; mortality

Outcome Measures

Primary Outcomes (2)

• 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.

  Within 21 days of hospitalization

• 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.

  90 days post-discharge

Secondary Outcomes (3)

• Rate of Recurrent Infections Within 90 Days of Hospital Discharge

  90 days post-discharge

• Incidence of Cardiovascular Events Within 90 Days of Hospital Discharge

  90 days post-discharge

• All-Cause Mortality Within 180 Days of Hospital Discharge.

  180 days post-discharge

Study Arms (1)

Hemodialysis patients with suspected catheter-related bloodstream infections (CRBSIs).

Study Population: The study will include 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. Study Procedure: During hospitalization, and as part of the clinical workup for sepsis, blood cultures will be obtained from three sources: 1. The central venous catheter (CVC), 2. The dialysis machine circuit, and 3. A peripheral vein. In addition, parathyroid hormone (PTH) levels will be measured through a blood sample.

Diagnostic Test: Blood cultures will be obtained from three sources: 1. The central venous catheter (CVC), 2. The dialysis machine circuit, and 3. A peripheral vein

Interventions

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_TEST

PTH levels during sepsis and compare them to baseline pre-infection levels, with serial follow-up of PTH values post-recovery.

Hemodialysis patients with suspected catheter-related bloodstream infections (CRBSIs).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (1)

Galilee Medical Center

Nahariya, Israel, 2210001, Israel

RECRUITING

Related Publications (24)

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MeSH Terms

Conditions

Sepsis; Infections

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Etty Kruzel-Davila, MD

CONTACT

972-4-9107619; ETTYK@gmc.gov.il

Olga Vdovich, MD

CONTACT

972-54-7628542; olgav@gmc.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Nephrology Department

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 9, 2025
• Study Start: August 16, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Individual participant data (IPD) and supporting information will be available beginning 6 months after publication of the primary results and will remain available for 5 years thereafter.
• Access Criteria: The individual participant data (IPD) and supporting documentation will be available beginning six months after publication of the study results in a peer-reviewed journal. Data will remain available for a period of five years following that date. A direct link to the IPD access page will be provided on the Galilee Medical Center website upon publication of the study results."

Locations

IL (1)