Condition category
Urological and Genital Diseases
Date applied
27/02/2007
Date assigned
27/02/2007
Last edited
27/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr H J T A M Huijbregts

ORCID ID

Contact details

University Medical Centre Utrecht (UMCU)
HP F 03.223
P.O. Box 85500
Heidelberglaan 100
Utrecht
3508 GA
Netherlands
+31 (0)30 250 7379
R.Huijbregts@azu.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Research to investigate whether ultrasonographically and histologically measured radial artery wall thickness are comparable, and whether this wall thickness is predictive for maturation of arteriovenous fistulas in haemodialysis patients.

Hypothesis:
Radial artery wall thickness is predictive for arteriovenous fistula maturation and can be measured by means of ultrasonography.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Non-randomised, non-controlled, parallel group, clinical trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Chronic renal insufficiency

Intervention

Excision biopsy of a small piece of the radial artery during operation.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Similarity between ulrasonographically measured and histologically measured radial artery wall thickness
2. Patency rates

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/01/2005

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Chronic renal failure and requirement of an arteriovenous fistula
2. Age 18 years or older
3. Informed consent

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

30

Participant exclusion criteria

1. Age less than 18 years
2. Placement of vascular access prosthesis
3. Unable to sign written informed consent

Recruitment start date

01/01/2005

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Utrecht (UMCU)
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (The Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Charity

Funder name

Dutch Kidney Foundation (Nierstichting Nederland) (The Netherlands)

Alternative name(s)

Dutch Kidney Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes