End Stage Renal Failure on DialysisNCT01727557
Anesthetic Technique for AV Fistulae Creation
A study testing regional anesthesia and local anesthesia in people with End Stage Renal Failure on Dialysis, run by Montefiore Medical Center at 1 site in United States.
Trial summary
This study is being done to compare the two anesthesia techniques which are commonly used in the formation of arteriovenous fistulas: local anesthesia and regional anesthesia. Local anesthesia means that, your doctor will inject numbing medication directly into the tissue or part of your body where the surgery will be… Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- End Stage Renal Failure on Dialysis
- What is being tested?
- regional anesthesia and local anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to 15 Jul 2016
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-70 years old
- Able to give informed consent
- Creation of first time AV fistula
- Possible 3 month follow up visit
- ASA-I-IV
Who cannot join
- BMI ≥40
- Repeated AV fistula creation,
- ASA -V,
- Allergic to local anesthetic agents,
- Significant lung and cardiac disease,
- Infection at the site of regional anesthesia,
- Pre-existing peripheral nerve damage,
- Significant bleeding disorders,
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
This study is being done to compare the two anesthesia techniques which are commonly used in the formation of arteriovenous fistulas: local anesthesia and regional anesthesia. Local anesthesia means that, your doctor will inject numbing medication directly into the tissue or part of your body where the surgery will be done. In this case, the numbing medication will be injected directly into the area where your fistula will be made. In regional anesthesia, the numbing medication will be injected around the nerve (part of the body that gives sensation) for your arm, to make the entire arm numb. The purpose of this study is to compare the three month success rates of AV fistulae created by the two anesthesia techniques.
Read the detailed description
The primary objectives of the study are:
- To evaluate the three-month success rate for AV fistulas constructed while using regional anesthesia against those constructed while using local anesthesia. Success will be evaluated by a dialysis access ultrasound, which will be performed three months after completion of the procedure. Successful will be defined as a mean blood flow of 600 ml/min and above, or receiving hemodialysis using the newly created AV fistula.
- To evaluate the immediate (within 3 days) and long-term complications three months after AV fistula construction under regional anesthesia or local anesthesia.
The secondary objective of the study is to use a short questionnaire survey To assess patient comfort level after creation of AV fistula (e.g. nausea, analgesia).
- Conditions
- End Stage Renal Failure on Dialysis
- Being tested
- regional anesthesia, local anesthesia
- Keywords
- Hemodialysis and AV 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.
regional anesthesiaProcedure or surgery
Regional anesthesia will be compared to local anesthesia
local anesthesiaProcedure or surgery
Regional anesthesia will be compared to local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Local anesthesia | Active comparator | Not described Receives: Procedure: regional anesthesia |
| regional anesthesia | Active comparator | Not described Receives: Procedure: local anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
AV fistula success rate
To evaluate the three-month success rate for AV fistulas constructed while using regional anesthesia against those constructed while using local anesthesia. Success will be evaluated by a dialysis access ultrasound, which will be performed three months after completion of the procedure. Successful will be defined as a mean blood flow of 600 ml/min and above, or receiving hemodialysis using the newly created AV fistula.
Measured: Three months from the day of creation
Secondary outcomes (2)
Short term comfort level
To assess patient comfort level after creation of AV fistula (e.g. nausea, analgesia).
Measured: Within three days of procedure
Short term safety, number of post operative complications
- To evaluate the immediate complications (within 3 days)after AV fistula construction under regional anesthesia or local anesthesia.
Measured: Three days after the creation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startFeb 2012
- Primary completion15 Jul 2016
- Study completion15 Jul 2016
Why it stopped: Low Accural Rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Failure on DialysisStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naum Shaparin, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727557
- Sponsor's protocol ID
- 11-08-302
- Status last verified
- Mar 2018
- First submitted
- 8 Jun 2012
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Technique for AV Fistulae Creation
- ClinicalTrials.gov ID
- NCT01727557
- Acronym / sponsor ID
- 11-08-302
- Conditions
- End Stage Renal Failure on Dialysis
- Keywords
- Hemodialysis and AV fistula
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Accural Rate
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- 15 Jul 2016 (actual)
- Study completion
- 15 Jul 2016 (actual)
- First posted
- 16 Nov 2012 (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.
This study is being done to compare the two anesthesia techniques which are commonly used in the formation of arteriovenous fistulas: local anesthesia and regional anesthesia. Local anesthesia means that, your doctor will inject numbing medication directly into the tissue or part of your body where the surgery will be done. In this case, the numbing medication will be injected directly into the area where your fistula will be made. In regional anesthesia, the numbing medication will be injected around the nerve (part of the body that gives sensation) for your arm, to make the entire arm numb. The purpose of this study is to compare the three month success rates of AV fistulae created by the two anesthesia techniques.
Detailed description
The primary objectives of the study are:
- To evaluate the three-month success rate for AV fistulas constructed while using regional anesthesia against those constructed while using local anesthesia. Success will be evaluated by a dialysis access ultrasound, which will be performed three months after completion of the procedure. Successful will be defined as a mean blood flow of 600 ml/min and above, or receiving hemodialysis using the newly created AV fistula.
- To evaluate the immediate (within 3 days) and long-term complications three months after AV fistula construction under regional anesthesia or local anesthesia.
The secondary objective of the study is to use a short questionnaire survey To assess patient comfort level after creation of AV fistula (e.g. nausea, analgesia).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local anesthesia | Active comparator | Procedure: regional anesthesia |
| regional anesthesia | Active comparator | Procedure: local anesthesia |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 21-70 years old
- Able to give informed consent
- Creation of first time AV fistula
- Possible 3 month follow up visit
- ASA-I-IV
Key exclusion criteria (8 listed)
- BMI ≥40
- Repeated AV fistula creation,
- ASA -V,
- Allergic to local anesthetic agents,
- Significant lung and cardiac disease,
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 |
|---|---|---|
| regional anesthesiaRegional anesthesia will be compared to local anesthesia | Procedure or surgery | Local anesthesia |
| local anesthesiaRegional anesthesia will be compared to local anesthesia | Procedure or surgery | regional anesthesia |
Primary outcome
AV fistula success rate
Time frame: Three months from the day of creation
To evaluate the three-month success rate for AV fistulas constructed while using regional anesthesia against those constructed while using local anesthesia. Success will be evaluated by a dialysis access ultrasound, which will be performed three months after completion of the procedure. Successful will be defined as a mean blood flow of 600 ml/min and above, or receiving hemodialysis using the newly created AV fistula.
2 secondary outcomes
Short term comfort level
Time frame: Within three days of procedure
Short term safety, number of post operative complications
Time frame: Three days after the creation
Results and safety
The study was stopped early (reason given: Low Accural Rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing regional anesthesia and local anesthesia in people with End Stage Renal Failure on Dialysis, run by Montefiore Medical Center at 1 site in United States.
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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 5 Mar 2018. 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 States. 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 was stopped early (reason given: Low Accural Rate). Results are not available in the source record.
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?
AV fistula success rate (time frame: Three months from the day of creation). 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 5 Mar 2018; AzTrials last refreshed its copy on 3 Nov 2026.