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

NCT01897857 | Completed

• 1 other identifier: 4-2013-0209
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

diabetes mellitus(DM); radial artery cannulation; artery blood flow; complication; End stage renal disease undergoing kidney transplantation

Outcome Measures

Primary Outcomes (1)

• 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

  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

Study Arms (2)

DM kidney transplantation

EXPERIMENTAL

patient with DM undergoing undergoing kidney transplantation

Device: duplex Doppler ultrasonography

without DM undergoing kidney transplantation

ACTIVE COMPARATOR

patient without DM undergoing undergoing kidney transplantation

Device: duplex Doppler ultrasonography

Interventions

duplex Doppler ultrasonography DEVICE

DM kidney transplantation; without DM undergoing kidney transplantation

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age \> 20yrs undergoing kidney transplantation
• ASA physical status ≥ 3
• patients with DM (DM group), patients without DM (nonDM group)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Diabetes Mellitus

Interventions

Ultrasonography, Doppler, Duplex

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography, Doppler; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: July 12, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: April 7, 2016

Record last verified: 2016-04

Locations

KR (1)