Renal FailureNCT01135979
Assessment of the Sympathetic Nervous System Blockade of the Upper Limb After a Brachial Plexus Block in Patients With End Stage Renal Failure
An observational study of Renal Failure, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate what effect a local anesthetic nerve block of the arm in patients with end stage renal failure has upon blood flow in the skin of the arm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2010to Dec 2012
- 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: Patients with end stage renal failure who are due to have a forearm fistula created
Who may be able to join
- Patients with end stage renal failure
- Over 18 years of age
- Written consent obtained
- Due to undergo surgery for forearm fistula creation under a regional block
Who cannot join
- Smokers
- Damaged skin on the arm
- Circulatory disorders such as Raynaud's disease, systemic sclerosis, sickle cell trait or disease
- Current use of beta blockers
- undergoing haemodialysis for more than 12 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG7 2UH
About this study
The purpose of this study is to investigate what effect a local anesthetic nerve block of the arm in patients with end stage renal failure has upon blood flow in the skin of the arm.
Read the detailed description
Aim
To quantify the degree of sympathetic blockade in the upper limb in patients with end stage renal failure produced during a regional anaesthetic technique, using laser Doppler flowmetry.
Hypothesis
Regional anaesthesia of the upper limb results in blockade of motor and sensory nerves, providing surgical and post-operative analgesia. Sympathetic nerves are also blocked resulting in local vasodilatation. This may be of benefit in surgery where enhanced blood flow is beneficial such as arterio-venous fistula creation. The degree and duration of sympathetic blockade produced by regional blocks however, has never been quantified. This study aims to quantify sympathetic blockade by measuring the changes in skin blood flow and skin temperature after placement of a brachial plexus block.
- Conditions
- Renal Failure
- Medical subject headings
- Renal Insufficiency
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 |
|---|---|---|
| Arterio-venous fistulae creation | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: Unable to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135979
- Sponsor's protocol ID
- 07AN007
- Status last verified
- Mar 2013
- First submitted
- 2 Jun 2010
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Sympathetic Nervous System Blockade of the Upper Limb After a Brachial Plexus Block in Patients With End Stage Renal Failure
- ClinicalTrials.gov ID
- NCT01135979
- Acronym / sponsor ID
- 07AN007
- Conditions
- Renal Failure
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to recruit
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 3 Jun 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.
The purpose of this study is to investigate what effect a local anesthetic nerve block of the arm in patients with end stage renal failure has upon blood flow in the skin of the arm.
Detailed description
Aim
To quantify the degree of sympathetic blockade in the upper limb in patients with end stage renal failure produced during a regional anaesthetic technique, using laser Doppler flowmetry.
Hypothesis
Regional anaesthesia of the upper limb results in blockade of motor and sensory nerves, providing surgical and post-operative analgesia. Sympathetic nerves are also blocked resulting in local vasodilatation. This may be of benefit in surgery where enhanced blood flow is beneficial such as arterio-venous fistula creation. The degree and duration of sympathetic blockade produced by regional blocks however, has never been quantified. This study aims to quantify sympathetic blockade by measuring the changes in skin blood flow and skin temperature after placement of a brachial plexus block.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arterio-venous fistulae creation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with end stage renal failure who are due to have a forearm fistula created
Key inclusion criteria (4 listed)
- Patients with end stage renal failure
- Over 18 years of age
- Written consent obtained
- Due to undergo surgery for forearm fistula creation under a regional block
Key exclusion criteria (5 listed)
- Smokers
- Damaged skin on the arm
- Circulatory disorders such as Raynaud's disease, systemic sclerosis, sickle cell trait or disease
- Current use of beta blockers
- undergoing haemodialysis for more than 12 months
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2013.
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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?
An observational study of Renal Failure, run by University of Nottingham 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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 6 Mar 2013. 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 was withdrawn before enrolling participants, so there are no results.
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.
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 6 Mar 2013.