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Clinical Trials/NCT05666375
NCT05666375
Not yet recruiting
Not Applicable

Percutaneous Translumbar Vs Transhepatic Insertion of Long Term Hemodialysis Catheters (Permcath) After Failure of Classic Accesses

Assiut University0 sites52 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
End Stage Renal Disease
Sponsor
Assiut University
Enrollment
52
Primary Endpoint
Catheter patency
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

The aim of the study is to emphasize the technique , success rate , efficacy of translumbar and transhepatic approaches and shed light on the complications of both methods and through comparison we can give recommendations to either of these methods.

Detailed Description

For selected ESRD patients who have exhausted all conventional access routes , translumbar and transhepatic permcath provide additional sites for access. This study will compare the two methods in terms of technical success (position of catheter tip), patency (primary defined as the number of catheter days from initial placement until removal \& secondary defined as the number of catheter days after device replacement using the same access site) , mean cumulative duration of catheter in situ defined as the cumulative catheter days divided by the number of patients, function (adequacy of dialysis based on Urea Reduction Ratio URR \& Simplified Daugirdas Formula Kt/V) and complications (infectious; exit site infection \& sepsis and non-infectious; thrombosis, catheter migration, hematoma, intraperitoneal hemorrhage.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
January 1, 2026
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Abdallah Morsy Mohamed Khalil

Dr

Assiut University

Eligibility Criteria

Inclusion Criteria

  • Chronic dialysis patients with failed classic routes of catheterization ( internal jugular, subclavian and femoral veins bilaterally ) as well as non-functioning a-v fistulas.

Exclusion Criteria

  • Patients with uncorrectable coagulopathy.
  • Patients on long term anticoagulants
  • Concurrent active infection.
  • Sgnificant abdominal ascites. (transhepatic)
  • Cirrhotic liver disease patients. (transhepatic)
  • Morbid obesity. (translumbar)

Outcomes

Primary Outcomes

Catheter patency

Time Frame: Baseline

patency (primary defined as the number of catheter days from initial placement until removal \& secondary defined as the number of catheter days after device replacement using the same access site) , mean cumulative duration of catheter in situ defined as the cumulative catheter days divided by the number of patients

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