Hemodialysis Catheter ComplicationNCT07645365
Hemodialysis Catheter Complications in the Emergency Department Versus Hemodialysis Unit
An observational study of Hemodialysis Catheter Complication and Catheter Thrombosis, run by Antalya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Catheter Complication, Catheter Thrombosis, Catheter-Related Infections
- How many people
- 398 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 11 Dec 2025
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Antalya Training and Research Hospital
Antalya, konyaaltı, 07100
About this study
Official title: Comparison of the Risk of Catheter Thrombosis and Catheter-Related Infection Between Patients Undergoing Hemodialysis Catheter Insertion in the Emergency Department and Those Undergoing Catheter Insertion in the Hemodialysis Unit: A Prospective Observational Study
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.
Read the detailed description
Hemodialysis catheters are frequently used as temporary vascular access in patients requiring urgent or ongoing hemodialysis. Although these catheters provide rapid access for dialysis, catheter-related complications such as thrombosis and infection may result in catheter dysfunction, interruption of dialysis, repeated catheter placement, increased morbidity, and additional healthcare burden.
In emergency departments, temporary hemodialysis catheters are often inserted under urgent clinical conditions. Although standard aseptic and antiseptic measures are applied, factors such as limited preparation time, clinical instability of the patient, and the need for rapid dialysis may affect the risk of catheter-related complications. In contrast, catheter insertion in a hemodialysis unit is generally performed in a more controlled clinical environment.
This prospective observational cohort study compared two groups of adult patients: those who underwent temporary hemodialysis catheter insertion in the emergency department and those who underwent catheter insertion in the nephrology hemodialysis unit. The primary focus was to evaluate whether the catheter insertion setting was associated with differences in the development of catheter thrombosis and catheter-related infection within ten days after catheter placement.
The study included 398 adult patients treated at Antalya Training and Research Hospital between December 1, 2024, and December 1, 2025. Demographic and clinical data were collected, and complications occurring within ten days after catheter insertion were assessed using hospital records and follow-up data. The findings of this study may help determine whether additional preventive measures are needed for hemodialysis catheter insertion procedures performed in emergency department settings.
- Conditions
- Hemodialysis Catheter Complication, Catheter Thrombosis, Catheter-Related Infections, Hemodialysis Vascular Access, Acute Kidney Failure
- Keywords
- Catheter-related infection, Dialysis catheter complications, Emergency department, Hemodialysis catheter
- Medical subject headings
- Catheter-Related Infections, Acute Kidney Injury, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 10 days after hemodialysis catheter insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Dec 2024
- Primary completion11 Dec 2025
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis Catheter ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 398 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Antalya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MEHMET AKCIMEN, Principal investigator, University of Health Sciences, Antalya Training and Research HospitalMURAT DUYAN, Study chair, University of Health Sciences, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645365
- Sponsor's protocol ID
- 2024-324
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 31585477Leblanc 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.
PubMed 9356690Fisher 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.
PubMed 31806658
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Risk of Catheter Thrombosis and Catheter-Related Infection Between Patients Undergoing Hemodialysis Catheter Insertion in the Emergency Department and Those Undergoing Catheter Insertion in the Hemodialysis Unit: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07645365
- Acronym / sponsor ID
- 2024-324
- Conditions
- Hemodialysis Catheter Complication, Catheter Thrombosis, Catheter-Related Infections, Hemodialysis Vascular Access, Acute Kidney Failure
- Keywords
- Catheter-related infection, Dialysis catheter complications, Emergency department, Hemodialysis catheter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Antalya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hemodialysis catheters are frequently used as temporary vascular access in patients requiring urgent or ongoing hemodialysis. Although these catheters provide rapid access for dialysis, catheter-related complications such as thrombosis and infection may result in catheter dysfunction, interruption of dialysis, repeated catheter placement, increased morbidity, and additional healthcare burden.
In emergency departments, temporary hemodialysis catheters are often inserted under urgent clinical conditions. Although standard aseptic and antiseptic measures are applied, factors such as limited preparation time, clinical instability of the patient, and the need for rapid dialysis may affect the risk of catheter-related complications. In contrast, catheter insertion in a hemodialysis unit is generally performed in a more controlled clinical environment.
This prospective observational cohort study compared two groups of adult patients: those who underwent temporary hemodialysis catheter insertion in the emergency department and those who underwent catheter insertion in the nephrology hemodialysis unit. The primary focus was to evaluate whether the catheter insertion setting was associated with differences in the development of catheter thrombosis and catheter-related infection within ten days after catheter placement.
The study included 398 adult patients treated at Antalya Training and Research Hospital between December 1, 2024, and December 1, 2025. Demographic and clinical data were collected, and complications occurring within ten days after catheter insertion were assessed using hospital records and follow-up data. The findings of this study may help determine whether additional preventive measures are needed for hemodialysis catheter insertion procedures performed in emergency department settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Catheter-Related Infection
Time frame: Within 10 days after hemodialysis catheter insertion
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.
Incidence of Catheter Thrombosis
Time frame: Within 10 days after hemodialysis catheter insertion
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 31585477Buetti 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.
- Background: PubMed 9356690Leblanc 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.
- Background: PubMed 31806658Fisher 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MEHMET AKCIMEN principal investigator
University of Health Sciences, Antalya Training and Research Hospital
MURAT DUYAN study chair
University of Health Sciences, Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis Catheter Complication and Catheter Thrombosis, run by Antalya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Catheter-Related Infection (time frame: Within 10 days after hemodialysis catheter insertion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07645365, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.