Percutaneous Translumbar Vs Transhepatic Permcath

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05666375
• Other study ID #: Unconventional permcath
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: December 2022
• Source: Assiut University
• Contact: Abdallah Morsy
• Phone: +2001093744274
• Email: Abdallahmorsynah96[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: January 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 75 Years

Eligibility

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:

1. Patients with uncorrectable coagulopathy.

2. Patients on long term anticoagulants

3. Concurrent active infection.

4. Sgnificant abdominal ascites. (transhepatic)

5. Cirrhotic liver disease patients. (transhepatic)

6. Morbid obesity. (translumbar)

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Procedure:
• Percutaneous translumbar and transhepatic permcath
For selected ESRD patients who have exhausted all conventional access routes , translumbar and transhepatic insertion of long term hemodialysis catheters provide additional sites for access

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

Farag YMK, El-Sayed E. Global Dialysis Perspective: Egypt. Kidney360. 2022 Apr 20;3(7):1263-1268. doi: 10.34067/KID.0007482021. eCollection 2022 Jul 28. No abstract available. — View Citation

Kade G, Les J, Buczkowska M, Labus M, Niemczyk S, Wankowicz Z. Percutaneous translumbar catheterization of the inferior vena cava as an emergency access for hemodialysis - 5 years of experience. J Vasc Access. 2014 Jul-Aug;15(4):306-10. doi: 10.5301/jva.5000185. Epub 2013 Nov 4. — View Citation

Lorenz JM. Unconventional venous access techniques. Semin Intervent Radiol. 2006 Sep;23(3):279-86. doi: 10.1055/s-2006-948767. — View Citation

Napalkov P, Felici DM, Chu LK, Jacobs JR, Begelman SM. Incidence of catheter-related complications in patients with central venous or hemodialysis catheters: a health care claims database analysis. BMC Cardiovasc Disord. 2013 Oct 16;13:86. doi: 10.1186/1471-2261-13-86. — View Citation

Zouaghi MK, Lammouchi MA, Hassan M, Rais L, Krid M, Smaoui W, Jebali H, Kheder R, Hamida FB, Moussa FB, Fatma LB, Beji S. Determinants of patency of arteriovenous fistula in hemodialysis patients. Saudi J Kidney Dis Transpl. 2018 May-Jun;29(3):615-622. doi: 10.4103/1319-2442.235183. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Catheter patency	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	Baseline