NCT04746742

Brief Summary

This study will compare the outcomes of tunneled femoral catheter and femoro-femoral arteriovenous graft as a bailout procedure for hemodialysis in chronic kidney disease patients with exhausted upper-extremity and chest-wall vascular accesses regarding survival rate, complications, and quality of life

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

January 10, 2021

Last Update Submit

February 4, 2021

Conditions

Vascular Access Complication

Outcome Measures

Primary Outcomes (1)

  • Primary patency

    In case of TFC: Normally an extracorporeal blood flow should be about 300 ml/min. based on this, the catheter dysfunction can be defined by the first occurrence of either (1) peak blood flow of 200 ml per minute or less for 30 minutes during a dialysis treatment, (2) mean blood flow of 250 ml per minute or less during two consecutive dialysis treatments, or (3) inability to initiate dialysis owing to inadequate blood flow, after attempts to restore patency have been attempted. \- In case of AVG, stenosis \> 50% of the prosthesis diameter or complete occlusion is considered significant. This can be assessed by duplex ultrasonography every six months or when the patency is questionable. The patency rates will be determined according to the reporting standards, set by the Committee of Reporting Standards for arteriovenous hemodialysis accesses.

    12 months postoperatively

Secondary Outcomes (3)

  • Secondary patency

    24 months

  • Special adverse events complicating lower-extremity haemodialysis access

    24 months

  • Patient satisfaction

    6 & 12 months postoperatively

Other Outcomes (3)

  • Operation time

    24 months

  • Hospital stay

    24 months

  • Survival rate

    24 months

Study Arms (2)

Tunneled femoral catheter

ACTIVE COMPARATOR

20 patients with end stage renal disease and exhausted upper-extremity and chest-wall vascular accesses will be randomly allocated to this group

Procedure: Tunneled Femoral Catheter (TFC) group

Femoral artery-femoral arteriovenous graft

ACTIVE COMPARATOR

a straight or loop configuration 28patients with end stage renal disease and exhausted upper-extremity and chest-wall vascular accesses will be randomly allocated to this group

Procedure: Femoro-femoral Arteriovenous graft (FF-AVG) group

Interventions

Tunneled Femoral Catheter (TFC) groupPROCEDURE

Patients with end-stage chronic kidney disease exhausted upper-extremity and chest-wall vascular accesses will be submitted to creation of a Lower-Extremity Hemodialysis Vascular either through application of tunneled femoral catheter

Tunneled femoral catheter
Femoro-femoral Arteriovenous graft (FF-AVG) groupPROCEDURE

Patients with end-stage chronic kidney disease exhausted upper-extremity and chest-wall vascular accesses will be submitted to creation of a Lower-Extremity Hemodialysis Vascular either through application of tunneled femoral catheter

Femoral artery-femoral arteriovenous graft

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All end-stage renal disease patients who complain of exhaustion of all upper-extremity and chest-wall vascular accesses.
  • ≥ 15 years

You may not qualify if:

  • patients with previous history or evident deep venous thrombosis
  • varicose veins
  • femoral vein stenosis
  • arterial insufficiency
  • severe groin or limb infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohammed Mosallam Mohammed Ibrahim

Al Mansurah, Dakahleyya, 35511, Egypt

RECRUITING

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Central Study Contacts

Mohammed Mosallam M Ibrahim, Specialist of Vascular Surgery

CONTACT

01001518995mohammedmosallam90@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist of Vascular Surgery, MD candidate

Study Record Dates

First Submitted

January 10, 2021

First Posted

February 10, 2021

Study Start

December 1, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

February 10, 2021

Record last verified: 2021-02

Locations

EG(1)