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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07847125
Ultrasound-Guided Percutaneous Peritoneal Dialysis Catheter Insertion for Urgent-Start Dialysis
Ultrasound-Guided Percutaneous Peritoneal Dialysis Catheter Insertion for Urgent-Start Dialysis: Feasibility, Technical Success, Safety, and Clinical Outcomes at Assiut University Hospital
This prospective observational study evaluates the feasibility, technical success, safety, and clinical outcomes of ultrasound-guided percutaneous peritoneal dialysis (PD) catheter insertion for urgent-start dialysis in pediatric patients with acute kidney injury (AKI).
Acute kidney injury in children frequently requires prompt renal replacement therapy. While traditional surgical placement of peritoneal dialysis catheters often requires general anesthesia and an extended waiting period before use, percutaneous insertion under real-time ultrasound guidance using a modified Seldinger technique allows for bedside placement under local anesthesia and rapid initiation of dialysis.
The study includes 50 pediatric patients (ranging from neonates up to 18 years of age) admitted to Assiut University Hospitals who require urgent renal replacement therapy and are candidates for peritoneal dialysis. Participants undergo percutaneous catheter placement guided in real time by ultrasound, followed by the initiation of an urgent-start dialysis protocol. The primary focus is to determine the technical success of the insertion procedure, evaluate catheter function and short-term catheter survival, and record procedure-related complications such as bleeding, dialysate leakage, infection, and mechanical malfunction. Secondary objectives include assessing renal recovery, patient survival to hospital discharge, and the need for conversion to alternative dialysis modalities.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
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Acepta Voluntarios Saludables
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Población de estudio
Pediatric patients (neonates up to 18 years of age) diagnosed with acute kidney injury according to KDIGO or pRIFLE criteria admitted to Assiut University Hospitals, Assiut, Egypt. The population includes patients requiring urgent renal replacement therapy who are candidates for peritoneal dialysis due to hemodynamic instability, lack of adequate vascular access, or clinical preference.
Descripción
Inclusion Criteria:
- Pediatric patients (neonates up to 18 years of age) diagnosed with acute kidney injury according to KDIGO or pRIFLE criteria.
- Clinical indication for urgent renal replacement therapy with candidacy for peritoneal dialysis (due to hemodynamic instability, lack of vascular access, or physician preference).
- Written informed consent provided by a parent or legal guardian.
Exclusion Criteria:
- Recent major abdominal surgery, abdominal wall defects, or necrotizing enterocolitis.
- Diaphragmatic hernia or ventriculoperitoneal (VP) shunt in situ.
- Uncontrolled peritonitis or intra-abdominal sepsis of surgical origin.
- Severe coagulopathy precluding safe percutaneous catheter insertion.
- Refusal of informed consent or inability to comply with protocol follow-up.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
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Pediatric Urgent-Start Peritoneal Dialysis Cohort
Pediatric patients (neonates up to 18 years) diagnosed with acute kidney injury according to KDIGO/pRIFLE criteria who require urgent renal replacement therapy and are candidates for peritoneal dialysis (due to hemodynamic instability, lack of vascular access, or clinical preference). All participants undergo percutaneous peritoneal dialysis catheter placement under real-time ultrasound guidance using a modified Seldinger technique, followed by the initiation of urgent-start peritoneal dialysis. Outcomes assessed include procedural feasibility, technical success, catheter function, short-term catheter survival, and procedure-related complications. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Technical Success of Catheter Placement
Periodo de tiempo: 1 hour post-procedure
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Technical success is defined as successful percutaneous placement of the peritoneal dialysis catheter into the peritoneal cavity under real-time ultrasound guidance with immediate functional inflow and outflow, confirmed by free instillation and drainage of fluid without leakage or obstruction. |
1 hour post-procedure
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Colaboradores e Investigadores
Patrocinador
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Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- US-Guided Urgent PD Catheter
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