NCT07645365

Brief Summary

This prospective observational cohort study was designed to compare the risk of catheter thrombosis and catheter-related infection between adult patients who underwent temporary hemodialysis catheter insertion in the emergency department and those who underwent catheter insertion in the hemodialysis unit. The study was conducted at Antalya Training and Research Hospital. Adult patients aged 18 years and older who underwent hemodialysis catheter insertion in either the emergency department or the nephrology hemodialysis unit were included. A total of 398 patients were enrolled between December 1, 2024, and December 1, 2025. Demographic and clinical data were collected, and catheter-related complications occurring within 10 days after catheter insertion were assessed using hospital records and follow-up data.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
398

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 9, 2026

Last Update Submit

June 9, 2026

Conditions

Keywords

Catheter-related infectionDialysis catheter complicationsEmergency departmentHemodialysis catheter

Outcome Measures

Primary Outcomes (2)

  • Incidence of Catheter-Related Infection

    The incidence of catheter-related infection will be assessed in adult patients who underwent temporary hemodialysis catheter insertion in either the emergency department or the hemodialysis unit. Catheter-related infection will be recorded based on clinical evaluation, laboratory findings when available, and hospital records during the 10-day follow-up period after catheter insertion.

    Within 10 days after hemodialysis catheter insertion

  • Incidence of Catheter Thrombosis

    The incidence of catheter thrombosis will be assessed in adult patients who underwent temporary hemodialysis catheter insertion in either the emergency department or the hemodialysis unit. Catheter thrombosis will be recorded based on clinical evaluation and hospital records during the 10-day follow-up period after catheter insertion.

    Within 10 days after hemodialysis catheter insertion

Study Arms (2)

Emergency Department Hemodialysis Catheter Group

Adult patients who underwent temporary hemodialysis catheter insertion in the emergency department. Participants were followed for 10 days after catheter insertion to assess the development of catheter thrombosis and catheter-related infection.

Hemodialysis Unit Catheter Group

Adult patients who underwent temporary hemodialysis catheter insertion in the nephrology hemodialysis unit. Participants were followed for 10 days after catheter insertion to assess the development of catheter thrombosis and catheter-related infection.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of adult patients aged 18 years and older who underwent temporary hemodialysis catheter insertion in either the emergency department or the nephrology hemodialysis unit at Antalya Training and Research Hospital between December 1, 2024, and December 1, 2025. Participants were followed for 10 days after catheter insertion to evaluate the development of catheter thrombosis and catheter-related infection.

You may qualify if:

  • Patients aged 18 years or older
  • Patients who underwent temporary hemodialysis catheter insertion in the emergency department
  • Patients who underwent temporary hemodialysis catheter insertion in the hemodialysis unit
  • Patients who agreed to participate in the study

You may not qualify if:

  • Patients younger than 18 years of age
  • Patients who did not agree to participate in the study
  • Patients with known platelet function disorder
  • Patients with hematologic diseases, including malignancy
  • Immunosuppressed patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Antalya Training and Research Hospital

Antalya, konyaaltı, 07100, Turkey (Türkiye)

Location

Related Publications (3)

  • Buetti N, Timsit JF. Management and Prevention of Central Venous Catheter-Related Infections in the ICU. Semin Respir Crit Care Med. 2019 Aug;40(4):508-523. doi: 10.1055/s-0039-1693705. Epub 2019 Oct 4.

    PMID: 31585477BACKGROUND
  • Leblanc M, Bosc JY, Paganini EP, Canaud B. Central venous dialysis catheter dysfunction. Adv Ren Replace Ther. 1997 Oct;4(4):377-89. doi: 10.1016/s1073-4449(97)70026-8.

    PMID: 9356690BACKGROUND
  • Fisher M, Golestaneh L, Allon M, Abreo K, Mokrzycki MH. Prevention of Bloodstream Infections in Patients Undergoing Hemodialysis. Clin J Am Soc Nephrol. 2020 Jan 7;15(1):132-151. doi: 10.2215/CJN.06820619. Epub 2019 Dec 5.

    PMID: 31806658BACKGROUND

MeSH Terms

Conditions

Catheter-Related InfectionsEmergencies

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • MEHMET AKCIMEN

    University of Health Sciences, Antalya Training and Research Hospital

    PRINCIPAL INVESTIGATOR
  • MURAT DUYAN

    University of Health Sciences, Antalya Training and Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2026

First Posted

June 12, 2026

Study Start

December 1, 2024

Primary Completion

December 11, 2025

Study Completion

December 11, 2025

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to privacy and confidentiality restrictions. The data used in this study contain patient-level clinical information, and no specific consent for public or external sharing of individual participant data was obtained. Only aggregated and anonymized results may be reported in scientific publications.

Locations