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Percutaneous Translumbar Vs Transhepatic Permcath

Primary Purpose

End Stage Renal Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Percutaneous translumbar and transhepatic permcath
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

5 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Percutaneous translumbar permcath

    Percutaneous transhepatic permcath

    Arm Description

    Local anesthesia in adults and general anesthesia in pediatrics. The patient under fasting condition is placed prone on angiography table. Skin preparation and a sterile draping of the operating field. Puncture site is chosen 1.5 cm above right iliac crest 10 cm lateral to the posterior median line. Puncture into inferior vena cava is made using 21 gauge 15 cm long needle, inserted at 45 degree angle from the horizontal and advanced medially and superiorly under us then fluoroscopic guidance. Entry into the IVC is made below the level of the renal veins, immediately anterior to the 3rd lumber vertebra. Intravascular position of the needle is confirmed by free aspiration of blood and injection of contrast media under fluoroscopy. A guide wire is introduced through the needle and advanced well into the IVC. The needle is replaced with a dilator. A catheter of appropriate length is tunneled subcutaneously from the right flank and advanced to the IVC

    The patient lies in supine position. The procedure is done under local anesthesia. Under ultrasound guidance; access by a 21 gauge angiocatheter (15cm) to right or middle hepatic vein through intercostal or subcostal approach. Entrance of the hepatic veins is confirmed by injection of diluted contrast media (iopromide) under fluoroscopy. A 0.018-inch guidewire is advanced through the needle and into the right atrium. Intravascular catheter length is measured and selected in standard fashion. The initial access needle is exchanged over the guidewire for a coaxial transitional sheath, which permits replacement of the 0.018-inch guidewire with a 0.035-inch guidewire. The tunneled catheter is inserted over the wire through a peel-away sheath

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    December 17, 2022
    Last Updated
    December 17, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05666375
    Brief Title
    Percutaneous Translumbar Vs Transhepatic Permcath
    Official Title
    Percutaneous Translumbar Vs Transhepatic Insertion of Long Term Hemodialysis Catheters (Permcath) After Failure of Classic Accesses
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2025 (Anticipated)
    Study Completion Date
    January 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    End Stage Renal Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Percutaneous translumbar permcath
    Arm Type
    Active Comparator
    Arm Description
    Local anesthesia in adults and general anesthesia in pediatrics. The patient under fasting condition is placed prone on angiography table. Skin preparation and a sterile draping of the operating field. Puncture site is chosen 1.5 cm above right iliac crest 10 cm lateral to the posterior median line. Puncture into inferior vena cava is made using 21 gauge 15 cm long needle, inserted at 45 degree angle from the horizontal and advanced medially and superiorly under us then fluoroscopic guidance. Entry into the IVC is made below the level of the renal veins, immediately anterior to the 3rd lumber vertebra. Intravascular position of the needle is confirmed by free aspiration of blood and injection of contrast media under fluoroscopy. A guide wire is introduced through the needle and advanced well into the IVC. The needle is replaced with a dilator. A catheter of appropriate length is tunneled subcutaneously from the right flank and advanced to the IVC
    Arm Title
    Percutaneous transhepatic permcath
    Arm Type
    Active Comparator
    Arm Description
    The patient lies in supine position. The procedure is done under local anesthesia. Under ultrasound guidance; access by a 21 gauge angiocatheter (15cm) to right or middle hepatic vein through intercostal or subcostal approach. Entrance of the hepatic veins is confirmed by injection of diluted contrast media (iopromide) under fluoroscopy. A 0.018-inch guidewire is advanced through the needle and into the right atrium. Intravascular catheter length is measured and selected in standard fashion. The initial access needle is exchanged over the guidewire for a coaxial transitional sheath, which permits replacement of the 0.018-inch guidewire with a 0.035-inch guidewire. The tunneled catheter is inserted over the wire through a peel-away sheath
    Intervention Type
    Procedure
    Intervention Name(s)
    Percutaneous translumbar and transhepatic permcath
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Catheter patency
    Description
    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
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abdallah Morsy
    Phone
    +2001093744274
    Email
    Abdallahmorsynah96@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hany Seif
    Phone
    +2001005618665
    Email
    Hanyseifrad@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24190069
    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.
    Results Reference
    background
    PubMed Identifier
    21326774
    Citation
    Lorenz JM. Unconventional venous access techniques. Semin Intervent Radiol. 2006 Sep;23(3):279-86. doi: 10.1055/s-2006-948767.
    Results Reference
    background
    PubMed Identifier
    24131509
    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.
    Results Reference
    background
    PubMed Identifier
    35919518
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29970738
    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.
    Results Reference
    background

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    Percutaneous Translumbar Vs Transhepatic Permcath

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