Using Antibiotics to Prevent Infections in Hemodialysis Patients During Catheter Placement

NCT06814223 | Recruiting Phase 4 DMC

• 1 other identifier: 0122-24- NHR
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine if prophylactic antibiotic treatment can reduce the incidence of early catheter-related infections in hemodialysis patients at high risk, including those with femoral catheter placement, atrial fibrillation, or heart failure. The main questions it aims to answer are:

• Be randomized into two groups: one receiving prophylactic antibiotics and one without antibiotics before catheter placement or replacement.
• Undergo follow-up for 45 days to monitor for catheter-related infections and secondary complications. This study will provide critical data to evaluate whether targeted prophylactic antibiotic treatment should become standard practice for high-risk hemodialysis patients.

Conditions

Infection Catheter-Related

Outcome Measures

Primary Outcomes (1)

• Early catheter-related infection, defined as an infection occurring within 45 days of tunneled catheter insertion.

  • Early catheter-related infection, defined as an infection occurring within 45 days of tunneled catheter insertion. (present/absent): These data will be collected from the patient's medical record based on clinical documentation of infection, including positive blood cultures.

  45 days after chatter insertion

Secondary Outcomes (3)

• Metastatic infection

  90 days after catheter infection

• Major adverse cardiovascular events (MACE):

  90 days after catheter insertion

• Mortality

  90 days after catheter insertion.

Study Arms (2)

PROPHYLACTIC ANTIBIOTIC

ACTIVE COMPARATOR

Patients with an elevated risk of infection will be randomly assigned to two groups using stratification for new catheter placement versus catheter replacement. Fifty percent of the high-risk patients will receive prophylactic antibiotics targeting gram-positive and gram-negative bacteria. The antibiotic regimen will include: * Cefamezine (2 grams) and gentamicin (80 mg) administered intravenously. * Patients with penicillin allergies, a history of methicillin-resistant Staphylococcus aureus (MRSA) infection, or known MRSA colonization will receive vancomycin (2 grams).

Drug: • Cefamezine (2 grams) and gentamicin (80 mg) administered intravenously. • Patients with penicillin allergies, a history of methicillin-resistant Staphylococcus aureus (MRSA) infection, or known MRSA

No

NO INTERVENTION

No prophylactic antibiotic before catheter insertion

Interventions

• Cefamezine (2 grams) and gentamicin (80 mg) administered intravenously. • Patients with penicillin allergies, a history of methicillin-resistant Staphylococcus aureus (MRSA) infection, or known MRSA DRUG

Patients with an elevated risk of infection will be randomly assigned to two groups using stratification for new catheter placement versus catheter replacement. Fifty percent of the high-risk patients will receive prophylactic antibiotics targeting gram-positive and gram-negative bacteria. The antibiotic regimen will include: * Cefamezine (2 grams) and gentamicin (80 mg) administered intravenously. * Patients with penicillin allergies, a history of methicillin-resistant Staphylococcus aureus (MRSA) infection, or known MRSA colonization will receive vancomycin (2 grams).

PROPHYLACTIC ANTIBIOTIC

Eligibility Criteria

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

You may qualify if:

• Hemodialysis patients scheduled for new tunneled catheter placement or replacement of an existing tunneled catheter.
• Prior diagnosis of at least one of the following conditions:
• Atrial fibrillation
• Heart failure
• Femoral tunneled catheter
• Patients who have signed informed consent to participate in the study.

You may not qualify if:

• Hemodialysis patients unable to provide informed consent and requiring a legal guardian.
• Patients undergoing prolonged antibiotic therapy prior to tunneled catheter insertion.

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (1)

Galilee Medical Center

Nahariya, Israel, 2210001, Israel

RECRUITING

Related Publications (1)

• 1. https://usrds-adr.niddk.nih.gov/2023/end-stage-renal-disease/4-vascular-access, 2021 2. Lassalle M, Monnet E, Ayav C, Hogan J, Moranne O, Couchoud C, et al. 2017 annual report digest of the renal epidemiology information network (REIN) registry. Transpl. Int. 2019;32(9):892-902. doi: 10.1111/tri.13466. 3. Arhuidese IJ, Cooper MA, Rizwan M, Nejim B, Malas MB. Vascular access for hemodialysis in the elderly. J. Vasc. Surg. 2019;69(2):517-525. doi: 10.1016/j.jvs.2018.05.219. 4. Ravani P, Palmer SC, Oliver MJ, Quinn RR, MacRae JM, Tai DJ, et al. Associations between hemodialysis access type and clinical outcomes: A systematic review. J. Am. Soc. Nephrol. 2013;24(3):465-473. doi: 10.1681/ASN.2012070643. 5. Aslam S, Vaida F, Ritter M, Ravindra L. Systematic review and meta-analysis on management of hemodialysis catheter-related bacteremia. J. Am. Soc. Nephrol. 2014;25(12):2927-2941. doi: 10.1681/ASN.2013091009. 6. Tokars JI, Miller ER, Stein G. New national surveillance system for hemodialysis associated infections: initial results. Am J Infect Control. 2002;30(5):288-295. 7. Chavers BM, Solid CA, Gilbertson DT, Collins AJ. Infection-related hospitalization rates in pediatric versus adult patients with end-stage renal disease in the United States. J Am Soc Nephrol. 2007 Mar;18(3):952-9. 8. Farrington CA, Allon M. Complications of Hemodialysis Catheter Bloodstream Infections: Impact of Infecting Organism. Am J Nephrol. 2019;50(2):126-132. 9. Delistefani, F., Wallbach, M., Müller, G.A. et al. Risk factors for catheter-related infections in patients receiving permanent dialysis catheter. BMC Nephrol 20, 199 (2019). 10. Huajie Guo , Ling Zhang ,Hua He , Lili Wang. Risk factors for catheter-associated bloodstream infection in hemodialysis patients: A meta-analysis. Published: March 27, 2024. Crossref DOI link: https://doi.org/10.1371/journal.pone.0299715 11. Pyry N. Sipilä, Joni V. Lindbohm, G. David Batty, Nelli Heikkilä, Jussi Vahtera, Sakari Suominen, Ari Väänänen

  BACKGROUND

MeSH Terms

Conditions

Catheter-Related Infections

Interventions

Cefazolin; Gentamicins

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Nephrology Department

Model Details: This prospective, randomized study will include patients from the hemodialysis unit at the Galilee Medical Center and community-based hemodialysis units. Eligible patients will have one or more of the following high-risk factors: femoral tunneled catheter placement, atrial fibrillation, and/or heart failure. Patients will be hospitalized for the insertion of a new tunneled catheter or the replacement of an existing malfunctioning tunneled catheter. Patients with an elevated risk of infection will be randomly assigned to two groups using stratification for new catheter placement versus catheter replacement. Fifty percent of the high-risk patients will receive prophylactic antibiotics targeting gram-positive and gram-negative bacteria 1 hour prior catheter insertion. The antibiotic regimen will include: • Cefamezine / vancomycin (2 grams)and gentamicin (80 mg) administered intravenously.

Study Record Dates

• First Submitted: January 26, 2025
• First Posted: February 7, 2025
• Study Start: October 28, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

IL (1)