End Stage Renal DiseaseNCT01897857
Influence of DM on Artery Blood Flow and Complications After Radial Artery Cannulation
A study testing duplex Doppler ultrasonography in people with End Stage Renal Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
In atherosclerotic patients undergoing kidney transplantation, arterial cannulation is commonly performed for continuous monitoring of systemic blood pressure and intermittent assessment of arterial blood gases. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- duplex Doppler ultrasonography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Jan 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age > 20yrs undergoing kidney transplantation
- ASA physical status ≥ 3
- patients with DM (DM group), patients without DM (nonDM group)
Who cannot join
- coagulopathy
- inflammation or infection at the puncture site for cannulation
- a positive result on the modified Allen's test
- the cannulation failed twice
- Acute renal allograft rejection
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine
Seoul, Seoul, 120-752
About this study
In atherosclerotic patients undergoing kidney transplantation, arterial cannulation is commonly performed for continuous monitoring of systemic blood pressure and intermittent assessment of arterial blood gases. The radial artery is the preferred artery, because of its well-documented low complication rate and easy access, but, radial artery cannulation is may associated with complications. Atherosclerosis is a systemic phenomenon, and structural changes attributable to atherosclerosis, such as luminal narrowing, intimal hyperplasia, and reduction in distensibility occur frequently throughout the arterial tree. Especially in patients with diabetes mellitus (DM), the radial artery is prone to atherosclerosis and perhaps calcification. In a recent study, it was found that the radial artery flow was decreased immediately after cannulation, but recovered to its pre-cannulation value after 5min, whereas a compensatory increase of blood flow in the ulnar artery occured immediately after cannulation, persisting until 5 min. This study enrolled the patients of ASA physical status 1-2. In the patients scheduled for elective kidney transplantation, this compensatory increase of blood flow in the ulnar artery may not be occurred, because of atherosclerosis, particularly in patients with DM. In our study, we found whether there is appropriate compensatory increase of blood flow in the ulnar artery after the radial artery cannulation in two groups, patients with DM (group DM) or without DM (group nonDM), both undergoing elective kidney transplantation.
- Conditions
- End Stage Renal Disease
- Being tested
- duplex Doppler ultrasonography
- Keywords
- diabetes mellitus(DM), radial artery cannulation, artery blood flow, complication, End stage renal disease undergoing kidney transplantation
- Medical subject headings
- Kidney Failure, Chronic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duplex Doppler ultrasonographyDevice
| Study group | Role | What they receive |
|---|---|---|
| DM kidney transplantation | Experimental | patient with DM undergoing undergoing kidney transplantation Receives: Device: duplex Doppler ultrasonography |
| without DM undergoing kidney transplantation | Active comparator | patient without DM undergoing undergoing kidney transplantation Receives: Device: duplex Doppler ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
the compensatory changes in ulnar artery blood flow after radial artery cannulation
to evaluate the compensatory changes in ulnar artery blood flow after radial artery cannulation using duplex Doppler ultrasonography at each time point
Measured: Change from Baseline in ulnar artery blood before anesthesia, before cannulation, 5 min after cannultion, 20 min after removal of the arterial catheter, 24 hous after cannulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897857
- Sponsor's protocol ID
- 4-2013-0209
- Status last verified
- Apr 2016
- First submitted
- 1 Jul 2013
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of DM on Artery Blood Flow and Complications After Radial Artery Cannulation
- ClinicalTrials.gov ID
- NCT01897857
- Acronym / sponsor ID
- 4-2013-0209
- Conditions
- End Stage Renal Disease
- Keywords
- diabetes mellitus(DM), radial artery cannulation, artery blood flow, complication, End stage renal disease undergoing kidney transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 12 Jul 2013 (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.
In atherosclerotic patients undergoing kidney transplantation, arterial cannulation is commonly performed for continuous monitoring of systemic blood pressure and intermittent assessment of arterial blood gases. The radial artery is the preferred artery, because of its well-documented low complication rate and easy access, but, radial artery cannulation is may associated with complications. Atherosclerosis is a systemic phenomenon, and structural changes attributable to atherosclerosis, such as luminal narrowing, intimal hyperplasia, and reduction in distensibility occur frequently throughout the arterial tree. Especially in patients with diabetes mellitus (DM), the radial artery is prone to atherosclerosis and perhaps calcification. In a recent study, it was found that the radial artery flow was decreased immediately after cannulation, but recovered to its pre-cannulation value after 5min, whereas a compensatory increase of blood flow in the ulnar artery occured immediately after cannulation, persisting until 5 min. This study enrolled the patients of ASA physical status 1-2. In the patients scheduled for elective kidney transplantation, this compensatory increase of blood flow in the ulnar artery may not be occurred, because of atherosclerosis, particularly in patients with DM. In our study, we found whether there is appropriate compensatory increase of blood flow in the ulnar artery after the radial artery cannulation in two groups, patients with DM (group DM) or without DM (group nonDM), both undergoing elective kidney transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DM kidney transplantation | Experimental | Device: duplex Doppler ultrasonographypatient with DM undergoing undergoing kidney transplantation |
| without DM undergoing kidney transplantation | Active comparator | Device: duplex Doppler ultrasonographypatient without DM undergoing undergoing kidney transplantation |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age > 20yrs undergoing kidney transplantation
- ASA physical status ≥ 3
- patients with DM (DM group), patients without DM (nonDM group)
Key exclusion criteria (5 listed)
- coagulopathy
- inflammation or infection at the puncture site for cannulation
- a positive result on the modified Allen's test
- the cannulation failed twice
- Acute renal allograft rejection
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 |
|---|---|---|
| duplex Doppler ultrasonography | Device | DM kidney transplantation, without DM undergoing kidney transplantation |
Primary outcome
the compensatory changes in ulnar artery blood flow after radial artery cannulation
Time frame: Change from Baseline in ulnar artery blood before anesthesia, before cannulation, 5 min after cannultion, 20 min after removal of the arterial catheter, 24 hous after cannulation
to evaluate the compensatory changes in ulnar artery blood flow after radial artery cannulation using duplex Doppler ultrasonography at each time point
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 7 Apr 2016.
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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 duplex Doppler ultrasonography in people with End Stage Renal Disease, run by Yonsei University at 1 site in South Korea.
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 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: finished, as of the sponsor's last update on 7 Apr 2016. 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 South Korea. 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?
the compensatory changes in ulnar artery blood flow after radial artery cannulation (time frame: Change from Baseline in ulnar artery blood before anesthesia, before cannulation, 5 min after cannultion, 20 min after removal of the arterial catheter, 24 hous after cannulation). 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 7 Apr 2016.