NCT01135979

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 6, 2013

Status Verified

March 1, 2013

Enrollment Period

2.8 years

First QC Date

June 2, 2010

Last Update Submit

March 5, 2013

Conditions

Study Arms (1)

Arterio-venous fistulae creation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with end stage renal failure who are due to have a forearm fistula created

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 3, 2010

Study Start

February 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 6, 2013

Record last verified: 2013-03

Locations