Influence of DM on Artery Blood Flow and Complications After Radial Artery Cannulation

NCT ID: NCT01897857

Last Updated: 2016-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-01-31

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.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

DM kidney transplantation

patient with DM undergoing undergoing kidney transplantation

Group Type: EXPERIMENTAL

duplex Doppler ultrasonography

Intervention Type: DEVICE

without DM undergoing kidney transplantation

patient without DM undergoing undergoing kidney transplantation

Group Type: ACTIVE_COMPARATOR

duplex Doppler ultrasonography

Intervention Type: DEVICE

Interventions

duplex Doppler ultrasonography

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Anesthesiology and Pain Medicine

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

4-2013-0209

Identifier Type: -

Identifier Source: org_study_id