AzTrials
AzTrials

Vascular Access ComplicationNCT04472221

Arterio-arterial Vascular Access as a Novel Technique for Treatment of Venous Hypertention With Arterio-venous Vascular Access

A study testing Arterioarterial synthetic graft in people with Vascular Access Complication, run by Mansoura University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Vascular Access Complication
What is being tested?
Arterioarterial synthetic graft
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
21 Jun 2018to 21 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • All vascular access with central venous hypertension with failed angioplasty

Who cannot join

  • infected access or rupture access

Trial locations and contacts

1 site in 1 country.

Mohamed S. Abdelgawwad, MD contact

01003919077 ext. 002

mshukri33@gmail.com

Egypt1 site, 1 recruiting
  • Mansoura University

    Al Mansurah, 35615

    Recruiting

Other trials in Egypt

About this study

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.

Read the detailed description

Abstract 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: we 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 investigator s 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.

Keywords: Arterio-arterial vascular access, Arterio-venous synthetic access, Venous hypertension, Hemodialysis patients.

Introduction:

In haemodialysis patients the investigator are confronted by patient with Left upper limb synthetic graft used for haemodialysis and the patient developed edema due to central venous occlusion ( venous hypertension) in the same limb. The other limb have no palpable pulse due to previous 3 operations for vascular access which ended by ligation of the brachial artery.

First the hope to dilatation of the central veins but this trial failed due to failure of the wire to cross the lesion, so we think to convert this arterio-venous graft to arterio-arterial access as we have previous experience with brachial aretrio-arterial vascular access.

One limitation of this technique was that the continuity of the brachial artery which will lead to thrombosis of the graft because of equal pressure in the graft and the brachial artery so ligation of the axillary artery below the proximal anastomosis was done despite our fear of ischaemia of the limb if the synthetic graft occluded later on.

Technique:

After failure of trial angioplasty of epsilateral central veins. This procedure was done either by local, regional, or general anesthesia (IV deprivan) according to the patient situation and surgeon preference.

Longitudinal incision (about 5-7cm) in the axilla at the arterio-venous anastomosis of the synthetic graft and along the course of the axillary artery , good hemostasis is needed because of the edema and the venous hypertension in the dilated collateral veins.

Good exposure of the end of the synthetic graft and mobilization of the axillary artery was done with ligation of intervening branches (a segment of 4-6 cm).

The synthetic graft catted and we do repair of the axillary vein. End to side anastomosis between the synthetic graft and the axillary artery by 6/0 proline then the axillary artery is ligated just below the anastomosis by 2/0 silk suture , now the blood is reversed in the synthetic graft and the blood flow from the axillary artery to the synthetic graft then to the brachial artery and radial and ulnar arteries.

Patients were discharged in the 2nd postoperative day unless need. Creep bandage was applied to the forearm and after 1-2 days the edema resolved and the patient regain the function of the upper limb and he can used the graft for dialysis immediately because the graft already healed and used previously for dialysis which is useful in those patients who has no venous access even for temporary catheter .

The same instructions as any arterio-arterial graft for hemodialysis were given to the patient and the medical stuff at dialysis unit as:

  • no medications given at the AAPL to avoid intra-arterial injection and acute ischemia.
  • Only pulse which can be palpated at the graft but no thrill.
  • Patency of the graft is done by palpation of the distal pulsation (distal brachial or radial artery) or duplex.
  • The puncture site needs more time of compression than that needed for AV grafts. (Khafagy et al.,)
Being tested
Arterioarterial synthetic graft

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arterioarterial synthetic graftProcedure or surgery

    Synthetic poly tetraflouroethylene graft

Study groups in NCT04472221
Study groupRoleWhat they receive
Vascular Access Venous HypertensionExperimentalSwollen upper limb with synthetic Arteriovenous graft
Receives: Procedure: Arterioarterial synthetic graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decrease the swelling of the upper limb gradually

    Measure of the whole cicumference

    Measured: Six month

  2. Patency of the dialysis access

    Duplex ultrasound assessment of the patency

    Measured: Six month

  3. Effeicient dialysis

    Continue haemodialysis of the access for 4 hours

    Measured: 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2020
  2. Study start21 Jun 2018
  3. Primary completion21 Jun 2021 (estimated)
  4. Study completion21 Jun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Experimental
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04472221
Sponsor's protocol ID
R.20.06.909 - 2020/06/24
Status last verified
Jul 2020
First submitted
1 Jul 2020
Last updated
15 Jul 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Arterioarterial synthetic graft in people with Vascular Access Complication, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohamed S. Abdelgawwad, MD (01003919077 ext. 002, mshukri33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease the swelling of the upper limb gradually (time frame: Six month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in