- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07645365
Hemodialysis Catheter Complications in the Emergency Department Versus Hemodialysis Unit
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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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konyaaltı
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Antalya, konyaaltı, Turecko (Türkiye), 07100
- University of Health Sciences, Antalya Training and Research Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
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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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Incidence of Catheter-Related Infection
Časové okno: Within 10 days after hemodialysis catheter insertion
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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.
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Within 10 days after hemodialysis catheter insertion
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Incidence of Catheter Thrombosis
Časové okno: Within 10 days after hemodialysis catheter insertion
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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.
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Within 10 days after hemodialysis catheter insertion
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: MEHMET AKCIMEN, University of Health Sciences, Antalya Training and Research Hospital
- Studijní židle: MURAT DUYAN, University of Health Sciences, Antalya Training and Research Hospital
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2024-324
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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