- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03397381
Outcome of Arterio-venous Fistula for Adult Hemodialysis Patients in Assiut Governorate
January 9, 2019 updated by: Hanan Sayed Hassan Mahrous, Assiut University
identification of the factors that affect the outcome of arteriovenous fistula in chronic renal failure patients that newly established regular dialysis in Assiut Governorate
- To study the factors that influence the outcome of AVF
- To evaluate the vascular complications of AVF as occlusion, rupture, aneurysmal dilation and hand ischemia
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assiut, Egypt, 71515
- Recruiting
- Hanan
-
Contact:
- Hanan S Mahrous, MD
- Phone Number: 01017031500
- Email: mostafak198173@yahoo.com
-
Contact:
- Mostafa K Ahmed, MD
- Phone Number: 01017035635
- Email: mostafaahmed15581@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Chronic renal Failure on regular dialysis
Description
Inclusion Criteria:
- all adult hemodialysis Patients in Assiut Government are eligible for enrollment if they are newly dialyzed via AVF and agree to participate in the study
Exclusion Criteria:
- Patients are not dialyzed with AVF
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the number of new renal failure patients with failed arteriovenous fistula as measured with arteriovenous duplex ultrasound imaging peak systolic velocity and end-diastolic velocity in Assiut Governorate
Time Frame: 3 years
|
the arteriovenous fistula will be named fail if one or more of the following
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the number deaths of renal failure patients on regular dialysis related to AVF complications in Assiut Governorate
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hanan S Mahrous, MD, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Stolic R. Most important chronic complications of arteriovenous fistulas for hemodialysis. Med Princ Pract. 2013;22(3):220-8. doi: 10.1159/000343669. Epub 2012 Nov 2.
- Lok CE. Fistula first initiative: advantages and pitfalls. Clin J Am Soc Nephrol. 2007 Sep;2(5):1043-53. doi: 10.2215/CJN.01080307. Epub 2007 Aug 16. No abstract available.
- Valliant A, McComb K. Vascular Access Monitoring and Surveillance: An Update. Adv Chronic Kidney Dis. 2015 Nov;22(6):446-52. doi: 10.1053/j.ackd.2015.06.002.
- Hammes M. Hemodynamic and biologic determinates of arteriovenous fistula outcomes in renal failure patients. Biomed Res Int. 2015;2015:171674. doi: 10.1155/2015/171674. Epub 2015 Oct 1.
- Padberg FT Jr, Calligaro KD, Sidawy AN. Complications of arteriovenous hemodialysis access: recognition and management. J Vasc Surg. 2008 Nov;48(5 Suppl):55S-80S. doi: 10.1016/j.jvs.2008.08.067.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 20, 2018
Primary Completion (Anticipated)
January 1, 2021
Study Completion (Anticipated)
January 1, 2022
Study Registration Dates
First Submitted
December 26, 2017
First Submitted That Met QC Criteria
January 10, 2018
First Posted (Actual)
January 12, 2018
Study Record Updates
Last Update Posted (Actual)
January 11, 2019
Last Update Submitted That Met QC Criteria
January 9, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Kidney Diseases
- Urologic Diseases
- Congenital Abnormalities
- Renal Insufficiency
- Pathological Conditions, Anatomical
- Renal Insufficiency, Chronic
- Cardiovascular Abnormalities
- Vascular Malformations
- Arteriovenous Malformations
- Vascular Fistula
- Kidney Failure, Chronic
- Fistula
- Arteriovenous Fistula
Other Study ID Numbers
- 17200155
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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