NCT04472221

Brief Summary

Arterio-arterial vascular access, Arterio-venous synthetic access, Venous hypertension, Hemodialysis patients Purpose: To describe a technique used to treat a patient with Lt upper limb synthetic arterio-venous vascular access and venous hypertension of the same limb. Technique: the investigator expose the venous anastomosis of the graft by small longitudinal incision in the axilla and dissection of the axillary artery just parallel to the axillary vein , the investigator disconnect the graft from the axillary vein and do primary repair of the vein , then the investigator do end to side anastomosis of the graft to the axillary artery , after finishing this anastomosis the axillary artery ligated just below the anastomosis. Conclusion: the conversion of arterio-venous graft to arterio-arterial vascular access in precious access with venous hypertension lead to resolution of edema of venous hypertension and preservation of access for dialysis.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2021

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

3 years

First QC Date

July 1, 2020

Last Update Submit

July 14, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Decrease the swelling of the upper limb gradually

    Measure of the whole cicumference

    Six month

  • Patency of the dialysis access

    Duplex ultrasound assessment of the patency

    Six month

  • Effeicient dialysis

    Continue haemodialysis of the access for 4 hours

    4 hours

Study Arms (1)

Vascular Access Venous Hypertension

EXPERIMENTAL

Swollen upper limb with synthetic Arteriovenous graft

Procedure: Arterioarterial synthetic graft

Interventions

Synthetic poly tetraflouroethylene graft

Vascular Access Venous Hypertension

Eligibility Criteria

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

You may qualify if:

  • All vascular access with central venous hypertension with failed angioplasty

You may not qualify if:

  • infected access or rupture access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, 35615, Egypt

RECRUITING

Central Study Contacts

Mohamed S. Abdelgawwad, MD

CONTACT

Tamer A. Khafagy, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Experimental
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 15, 2020

Study Start

June 21, 2018

Primary Completion

June 21, 2021

Study Completion

June 21, 2021

Last Updated

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations