Renal Replacement TherapyNCT01099189
Vein Histology in Arteriovenous Fistulas and Its Effect on Fistula Surgery Success
An observational study of Renal Replacement Therapy and Arteriovenous Fistula, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Patients whose kidneys have failed need to receive dialysis treatment, most commonly with a dialysis machine. In order to be connected to the machine an operation is often performed to join an artery to a vein in the arm. This forms what is known as an arteriovenous fistula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Replacement Therapy, Arteriovenous Fistula
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2010to Jul 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patient referred for access formation
Who may be able to join
- Patients referred to vascular consultants for AV fistula formation for haemodialysis access.
- Ability to give informed written consent
- Aged over 18 at time of referral
Who cannot join
- Veins identified on preoperative ultrasound scanning to be of a calibre too small to allow sufficient material to be obtained for biomechanical testing (<3mm diameter).
- Inability to give informed written consent
- Aged under 18 at time of referral
- Inability to attend follow-up appointments
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Academic Vascular Surgery Unit
Hull, Yorkshire, HU3 2JZ
About this study
Official title: A Cohort Study of the Histopathological Changes Evident in Vein Wall at the Time of Arteriovenous Dialysis Access Fistulas and the Effects of Such Changes on Biomechanical Compliance and Patient's Clinical Outcomes in a University Teaching Hospital.
Patients whose kidneys have failed need to receive dialysis treatment, most commonly with a dialysis machine. In order to be connected to the machine an operation is often performed to join an artery to a vein in the arm. This forms what is known as an arteriovenous fistula. The fistula causes an increase in the flow of blood through the vein and the vein reacts to this by becoming bigger and thicker, making it easier to connect the patient to the machine.
The success rate for the operation is relatively low and only approximately 65 from every 100 operations is still working after a year. It is thought that one factor that may cause problems with the fistula is the ability of the vein to stretch in response to increased blood flow. Previous research has shown that veins in kidney failure patients look different to those of people whose kidneys are working when viewed under a microscope.
The investigators aim to study the structure of the vein that is used in making fistulas with a microscope and also to test it in an engineering laboratory to see how much it will stretch. The investigators hope that gaining information about the structure of the vein and its ability to stretch will help determine what it is about the vein that affects how well it works as part of a fistula. This information may help surgeons select the best possible vein in a given patient to give the best chance of a working fistula in the future.
- Conditions
- Renal Replacement Therapy, Arteriovenous Fistula
- Keywords
- Histology, Compliance, Dialysis, Arteriovenous access fistula, vein
- Medical subject headings
- Arteriovenous Fistula, Patient Compliance
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 |
|---|---|---|
| Observed cohort | All patients recruited. Observed for clinical outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary failure of access - Immediate/early thrombosis or failure to mature.
Failure to mature or thrombosis of fistula
Measured: within 30 days of formation
Secondary outcomes (5)
Duplex findings of evidence of stenosis and correlation to compliance or histological findings
Measured: 6 months
Correlation between biomechanical compliance and histological measures of pre existing venous pathology
Measured: 6 months
Correlation between biomechanical compliance testing and clinical outcomes
Measured: 6 months
Assisted primary and secondary patency rates at 3 and 6 months post fistula formation
Measured: 6 months
Functional primary patency
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2012
- Study completionJul 2013
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 Renal Replacement TherapyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Hull
- Responsible party
- Sponsor
- Investigators
- Ian C Chetter, MBChB FRCS, Principal investigator, University of Hull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099189
- Sponsor's protocol ID
- Access 4
- Status last verified
- Jul 2019
- First submitted
- 5 Apr 2010
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Smith GE, Gohil R, Chetter IC. Factors affecting the patency of arteriovenous fistulas for dialysis access. J Vasc Surg. 2012 Mar;55(3):849-55. doi: 10.1016/j.jvs.2011.07.095. Epub 2011 Nov 8.
PubMed 22070937
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of the Histopathological Changes Evident in Vein Wall at the Time of Arteriovenous Dialysis Access Fistulas and the Effects of Such Changes on Biomechanical Compliance and Patient's Clinical Outcomes in a University Teaching Hospital.
- ClinicalTrials.gov ID
- NCT01099189
- Acronym / sponsor ID
- Access 4
- Conditions
- Renal Replacement Therapy, Arteriovenous Fistula
- Keywords
- Histology, Compliance, Dialysis, Arteriovenous access fistula, vein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- University of Hull
- Study start
- Jul 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 Apr 2010 (estimated)
- 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.
Patients whose kidneys have failed need to receive dialysis treatment, most commonly with a dialysis machine. In order to be connected to the machine an operation is often performed to join an artery to a vein in the arm. This forms what is known as an arteriovenous fistula. The fistula causes an increase in the flow of blood through the vein and the vein reacts to this by becoming bigger and thicker, making it easier to connect the patient to the machine.
The success rate for the operation is relatively low and only approximately 65 from every 100 operations is still working after a year. It is thought that one factor that may cause problems with the fistula is the ability of the vein to stretch in response to increased blood flow. Previous research has shown that veins in kidney failure patients look different to those of people whose kidneys are working when viewed under a microscope.
The investigators aim to study the structure of the vein that is used in making fistulas with a microscope and also to test it in an engineering laboratory to see how much it will stretch. The investigators hope that gaining information about the structure of the vein and its ability to stretch will help determine what it is about the vein that affects how well it works as part of a fistula. This information may help surgeons select the best possible vein in a given patient to give the best chance of a working fistula in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observed cohort | – | –All patients recruited. Observed for clinical outcomes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patient referred for access formation
Key inclusion criteria (3 listed)
- Patients referred to vascular consultants for AV fistula formation for haemodialysis access.
- Ability to give informed written consent
- Aged over 18 at time of referral
Key exclusion criteria (4 listed)
- Veins identified on preoperative ultrasound scanning to be of a calibre too small to allow sufficient material to be obtained for biomechanical testing (<3mm diameter).
- Inability to give informed written consent
- Aged under 18 at time of referral
- Inability to attend follow-up appointments
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
Primary failure of access - Immediate/early thrombosis or failure to mature.
Time frame: within 30 days of formation
Failure to mature or thrombosis of fistula
5 secondary outcomes
Duplex findings of evidence of stenosis and correlation to compliance or histological findings
Time frame: 6 months
Correlation between biomechanical compliance and histological measures of pre existing venous pathology
Time frame: 6 months
Correlation between biomechanical compliance testing and clinical outcomes
Time frame: 6 months
Assisted primary and secondary patency rates at 3 and 6 months post fistula formation
Time frame: 6 months
Functional primary patency
Time frame: 6 months
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 12 Jul 2019.
- Results publication: PubMed 22070937Smith GE, Gohil R, Chetter IC. Factors affecting the patency of arteriovenous fistulas for dialysis access. J Vasc Surg. 2012 Mar;55(3):849-55. doi: 10.1016/j.jvs.2011.07.095. Epub 2011 Nov 8.
Related trials for Renal Replacement Therapy
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Not yet recruitingObservational study
Pharmacokinetics and Optimal Dosing of Levetiracetam in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy
Continuous Renal Replacement Therapy (CRRT), Pharmacokinetics
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
Recruiting
Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure
Acute Kidney Injury, Fluid Overload
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.
Ian C Chetter, MBChB FRCS principal investigator
University of Hull
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Replacement Therapy and Arteriovenous Fistula, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 3 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 12 Jul 2019. 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 United Kingdom. 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 failure of access - Immediate/early thrombosis or failure to mature. (time frame: within 30 days of formation). 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 NCT01099189, 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 12 Jul 2019.