Hemodialysis Access FailureNCT04388397
Immediate-access Arteriovenous Versus Standard Arteriovenous Grafts in Hemodialysis Patients
A study testing Arteriovenous Grafts in people with Hemodialysis Access Failure, run by Egyptian Biomedical Research Network at 2 sites in Egypt.
Trial summary
Arteriovenous fistulae (AVF) are considered the main access for hemodialysis (HD). Arteriovenous grafts (AVGs) are an alternative access modality in patients with exhausted native venous access. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemodialysis Access Failure
- What is being tested?
- Arteriovenous Grafts
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 477 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Aug 2017to 10 Apr 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult hemodialysis patients
Who cannot join
- Significant cardiorespiratory comorbidities.
- Peripheral vascular disease.
- Pregnancy or lactation.
- Severe bleeding disorders.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Medicine, Zagazig University
Zagazig
Faculty of Medicine
Zagazig
About this study
Official title: Immediate-access Arteriovenous Versus Standard Arteriovenous Grafts in Hemodialysis Patients: A Randomized Clinical Study
Arteriovenous fistulae (AVF) are considered the main access for hemodialysis (HD). Arteriovenous grafts (AVGs) are an alternative access modality in patients with exhausted native venous access. Immediate-access arteriovenous grafts (IAAVGs) is a new modality in which dialysis can be started immediately to avoid complications of central venous catheters.
Read the detailed description
The study aimed to evaluate and compare patency rate and complications of standard arteriovenous grafts (SAVGs) and immediate-access arteriovenous grafts (IAAVGs) in end stage renal disease (ESRD) patients for one year after the intervention. Patients were randomly divided into two groups: SAVGs group and IAAVGs group. Patients with ESRD with no chance for native AVF were examined clinically and by duplex ultrasonography preoperatively. Follow up was for one year. Primary end points were the success rate, complications rate (hematoma, pseudo-aneurysm, graft site infection, systemic bacteremia), time of first cannulation. Secondary end points were primary and secondary patency within one year.
- Conditions
- Hemodialysis Access Failure
- Being tested
- Arteriovenous Grafts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arteriovenous GraftsProcedure or surgery
Arteriovenous fistulae (AVF) are considered the main access for hemodialysis (HD). Arteriovenous grafts (AVGs) are an alternative access modality in patients with exhausted native venous access. Immediate-access arteriovenous grafts (IAAVGs) is a new modality in which dialysis can be started immediately to avoid complications of central venous catheters.
| Study group | Role | What they receive |
|---|---|---|
| Immediate-access Arteriovenous Grafts | Experimental | Immediate-access Arteriovenous Grafts as a vascular access for hemodialysis patients Receives: Procedure: Arteriovenous Grafts |
| Standard Arteriovenous Grafts | Active comparator | Standard Arteriovenous Grafts as a vascular access for hemodialysis patients Receives: Procedure: Arteriovenous Grafts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency
Patency of hemodialysis access
Measured: 1 year
Success rate
successful graft procedure
Measured: 24 hours
Secondary outcomes (1)
Complications rate
Any graft complications
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start15 Aug 2017
- Primary completion10 Apr 2020
- Study completion10 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis Access FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 477 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Biomedical Research Network
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Ahmed Tawfik, PhD, Principal investigator, Faculty of Medicine, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388397
- Sponsor's protocol ID
- 02090520
- Status last verified
- Jul 2020
- First submitted
- 9 May 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tawfik AM, Zidan MH, Salem A, Salem A. A randomized controlled study of early versus standard cannulation of arteriovenous grafts in hemodialysis patients. J Vasc Surg. 2022 Mar;75(3):1047-1053. doi: 10.1016/j.jvs.2021.08.106. Epub 2021 Sep 30.
PubMed 34601044
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate-access Arteriovenous Versus Standard Arteriovenous Grafts in Hemodialysis Patients: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT04388397
- Acronym / sponsor ID
- 02090520
- Conditions
- Hemodialysis Access Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- Egyptian Biomedical Research NetworkResearch network
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 14 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Arteriovenous fistulae (AVF) are considered the main access for hemodialysis (HD). Arteriovenous grafts (AVGs) are an alternative access modality in patients with exhausted native venous access. Immediate-access arteriovenous grafts (IAAVGs) is a new modality in which dialysis can be started immediately to avoid complications of central venous catheters.
Detailed description
The study aimed to evaluate and compare patency rate and complications of standard arteriovenous grafts (SAVGs) and immediate-access arteriovenous grafts (IAAVGs) in end stage renal disease (ESRD) patients for one year after the intervention. Patients were randomly divided into two groups: SAVGs group and IAAVGs group. Patients with ESRD with no chance for native AVF were examined clinically and by duplex ultrasonography preoperatively. Follow up was for one year. Primary end points were the success rate, complications rate (hematoma, pseudo-aneurysm, graft site infection, systemic bacteremia), time of first cannulation. Secondary end points were primary and secondary patency within one year.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate-access Arteriovenous Grafts | Experimental | Procedure: Arteriovenous GraftsImmediate-access Arteriovenous Grafts as a vascular access for hemodialysis patients |
| Standard Arteriovenous Grafts | Active comparator | Procedure: Arteriovenous GraftsStandard Arteriovenous Grafts as a vascular access for hemodialysis patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult hemodialysis patients
Key exclusion criteria (4 listed)
- Significant cardiorespiratory comorbidities.
- Peripheral vascular disease.
- Pregnancy or lactation.
- Severe bleeding disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arteriovenous GraftsArteriovenous fistulae (AVF) are considered the main access for hemodialysis (HD). Arteriovenous grafts (AVGs) are an alternative access modality in patients with exhausted native venous access. Immediate-access arteriovenous grafts (IAAVGs) is a new modality in which dialysis can be started immediately to avoid complications of central venous catheters. | Procedure or surgery | Immediate-access Arteriovenous Grafts, Standard Arteriovenous Grafts |
Primary outcome
Primary Patency
Time frame: 1 year
Patency of hemodialysis access
Success rate
Time frame: 24 hours
successful graft procedure
1 secondary outcome
Complications rate
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Derived from this study: PubMed 34601044Tawfik AM, Zidan MH, Salem A, Salem A. A randomized controlled study of early versus standard cannulation of arteriovenous grafts in hemodialysis patients. J Vasc Surg. 2022 Mar;75(3):1047-1053. doi: 10.1016/j.jvs.2021.08.106. Epub 2021 Sep 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Tawfik, PhD principal investigator
Faculty of Medicine, Zagazig University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arteriovenous Grafts in people with Hemodialysis Access Failure, run by Egyptian Biomedical Research Network at 2 sites 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 4 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: finished, as of the sponsor's last update on 23 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 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04388397, which also lists 1 linked publication.
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 23 Jul 2020.