Arteriovenous FistulaNCT03171701
Color Doppler Ultrasonography in Prediction of Arteriovenous Fistula Maturation in Hemodialysis Patients
An observational study of Arteriovenous Fistula, run by Assiut University.
Trial summary
The transplant is the definitive treatment of renal insufficiency, in our days. While waiting for it, the arteriovenous fistula surgery is standard procedure. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Arteriovenous Fistula
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2017to 1 Oct 2018
- Phase
- Observational
- 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
Study population: This study will be performed at Radiodiagnostic department, Assiut Police Hospital and assiut university hospital on all newly placed arteriovenous fistula for hemodialysis.
Who may be able to join
- 1) Patients Of Chronic Renal Failure With Newly Placed AVF. 2)Clinically Stable Patients For Assessment Of Maturation Of AVF. 3) Complaints Of Hand Pain Or Numbness Following Creation Of The Access.
Who cannot join
- 1)Previously Failed AV Fistulas. 2)Deformed Or Scarred Upper Limb.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Color Doppler Ultrasonography in Prediction of Arteriovenous Fistula Maturation and Its Complications in Hemodialysis Patients
The transplant is the definitive treatment of renal insufficiency, in our days. While waiting for it, the arteriovenous fistula surgery is standard procedure.
Read the detailed description
Ultrasound is the main method of diagnostic imaging, because of its low cost, noninvasive without ionizing radiation associated or iodized contrast.
Vascular procedures and their complications represent a major cause of morbidity hospitalization and cost for patients in hemodialysis .
Many fistulas do not mature appropriately for being used in dialysis. So,The early recognition through the ultrasound examination of problems in the arteriovenous fistula maturation or possible complications that may compromise their viability, offers the opportunity of correction or appropriate treatment .
Criteria for maturation after arteriovenous fistula creation:
- Vein diameter larger than 4 mm remote from the site of fistula.
- Vein located at a depth of <5 mm from skin surface.
- Conditions
- Arteriovenous Fistula
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| maturation of arteriovenous fistula | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of color Doppler ultrasonography in prediction of arteriovenous fistula maturation and its complications in hemodialysis patients
Assess and monitor the maturation of the newly placed Arteriovenous fistulas, and to provide timely interventions for AV fistulas which are failing to mature
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Jul 2017 (estimated)
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
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 Arteriovenous FistulaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HFoad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171701
- Sponsor's protocol ID
- arteriovenous fistula
- Status last verified
- Jun 2017
- First submitted
- 29 May 2017
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malovrh M. Postoperative assessment of vascular access. J Vasc Access. 2014;15 Suppl 7:S10-4. doi: 10.5301/jva.5000243. Epub 2014 Apr 17.
PubMed 24817448
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Color Doppler Ultrasonography in Prediction of Arteriovenous Fistula Maturation and Its Complications in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03171701
- Acronym / sponsor ID
- arteriovenous fistula
- Conditions
- Arteriovenous Fistula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 31 May 2017 (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.
The transplant is the definitive treatment of renal insufficiency, in our days. While waiting for it, the arteriovenous fistula surgery is standard procedure.
Detailed description
Ultrasound is the main method of diagnostic imaging, because of its low cost, noninvasive without ionizing radiation associated or iodized contrast.
Vascular procedures and their complications represent a major cause of morbidity hospitalization and cost for patients in hemodialysis .
Many fistulas do not mature appropriately for being used in dialysis. So,The early recognition through the ultrasound examination of problems in the arteriovenous fistula maturation or possible complications that may compromise their viability, offers the opportunity of correction or appropriate treatment .
Criteria for maturation after arteriovenous fistula creation:
- Vein diameter larger than 4 mm remote from the site of fistula.
- Vein located at a depth of <5 mm from skin surface.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| maturation of arteriovenous fistula | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will be performed at Radiodiagnostic department, Assiut Police Hospital and assiut university hospital on all newly placed arteriovenous fistula for hemodialysis.
Key inclusion criteria (1 listed)
- 1) Patients Of Chronic Renal Failure With Newly Placed AVF. 2)Clinically Stable Patients For Assessment Of Maturation Of AVF. 3) Complaints Of Hand Pain Or Numbness Following Creation Of The Access.
Key exclusion criteria (1 listed)
- 1)Previously Failed AV Fistulas. 2)Deformed Or Scarred Upper Limb.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Role of color Doppler ultrasonography in prediction of arteriovenous fistula maturation and its complications in hemodialysis patients
Time frame: one month
Assess and monitor the maturation of the newly placed Arteriovenous fistulas, and to provide timely interventions for AV fistulas which are failing to mature
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Background: PubMed 24817448Malovrh M. Postoperative assessment of vascular access. J Vasc Access. 2014;15 Suppl 7:S10-4. doi: 10.5301/jva.5000243. Epub 2014 Apr 17.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriovenous Fistula, run by Assiut University.
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 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Hossam Abu Zeid, A. Professor (00201063602906, Hosameldeen68@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of color Doppler ultrasonography in prediction of arteriovenous fistula maturation and its complications in hemodialysis patients (time frame: one month). 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 NCT03171701, 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 8 Jun 2017.