Influence of DM on Artery Blood Flow and Complications After Radial Artery Cannulation
Primary Purpose
End Stage Renal Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
duplex Doppler ultrasonography
Sponsored by
About this trial
This is an interventional prevention trial for End Stage Renal Disease focused on measuring diabetes mellitus(DM), radial artery cannulation, artery blood flow, complication, End stage renal disease undergoing kidney transplantation
Eligibility Criteria
Inclusion Criteria:
- age > 20yrs undergoing kidney transplantation
- ASA physical status ≥ 3
- patients with DM (DM group), patients without DM (nonDM group)
Exclusion Criteria:
- 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
Sites / Locations
- Department of Anesthesiology and Pain Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DM kidney transplantation
without DM undergoing kidney transplantation
Arm Description
patient with DM undergoing undergoing kidney transplantation
patient without DM undergoing undergoing kidney transplantation
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01897857
Brief Title
Influence of DM on Artery Blood Flow and Complications After Radial Artery Cannulation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
diabetes mellitus(DM), radial artery cannulation, artery blood flow, complication, End stage renal disease undergoing kidney transplantation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DM kidney transplantation
Arm Type
Experimental
Arm Description
patient with DM undergoing undergoing kidney transplantation
Arm Title
without DM undergoing kidney transplantation
Arm Type
Active Comparator
Arm Description
patient without DM undergoing undergoing kidney transplantation
Intervention Type
Device
Intervention Name(s)
duplex Doppler ultrasonography
Primary Outcome Measure Information:
Title
the compensatory changes in ulnar artery blood flow after radial artery cannulation
Description
to evaluate the compensatory changes in ulnar artery blood flow after radial artery cannulation using duplex Doppler ultrasonography at each time point
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age > 20yrs undergoing kidney transplantation
ASA physical status ≥ 3
patients with DM (DM group), patients without DM (nonDM group)
Exclusion Criteria:
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
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
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Influence of DM on Artery Blood Flow and Complications After Radial Artery Cannulation
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