Acute Kidney InjuryNCT07847125
Ultrasound-Guided Percutaneous Peritoneal Dialysis Catheter Insertion for Urgent-Start Dialysis
An observational study of Acute Kidney Injury and Catheter-Related Complications, run by Assiut University.
Trial summary
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). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Acute Kidney Injury, Catheter-Related Complications, Pediatric Renal Disease
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- Child, Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Keywords
- Urgent-Start Peritoneal Dialysis, Percutaneous Catheter Insertion, Ultrasound-Guided Access, Modified Seldinger Technique, Pediatric Acute Kidney Injury, Interventional Radiology, Tenckhoff Catheter
- Medical subject headings
- Acute Kidney Injury
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 |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success of Catheter Placement
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.
Measured: 1 hour post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shehab Ezz Eldin Mohamed Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847125
- Sponsor's protocol ID
- US-Guided Urgent PD Catheter
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Percutaneous Peritoneal Dialysis Catheter Insertion for Urgent-Start Dialysis: Feasibility, Technical Success, Safety, and Clinical Outcomes at Assiut University Hospital
- ClinicalTrials.gov ID
- NCT07847125
- Acronym / sponsor ID
- US-Guided Urgent PD Catheter
- Keywords
- Urgent-Start Peritoneal Dialysis, Percutaneous Catheter Insertion, Ultrasound-Guided Access, Modified Seldinger Technique, Pediatric Acute Kidney Injury, Interventional Radiology, Tenckhoff Catheter
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 29 Sep 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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
Technical Success of Catheter Placement
Time frame: 1 hour post-procedure
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Catheter-Related Complications, run by Assiut University.
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 3 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: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Technical Success of Catheter Placement (time frame: 1 hour post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.