Wall thickness measurement by ultrasonography as a predictor for arteriovenous fistula function in haemodialysis patients

ISRCTN ISRCTN30488563
DOI https://doi.org/10.1186/ISRCTN30488563
Protocol serial number N/A
Sponsor University Medical Centre Utrecht (UMCU) (The Netherlands)
Funder Dutch Kidney Foundation (Nierstichting Nederland) (The Netherlands)
Submission date
27/02/2007
Registration date
27/02/2007
Last edited
27/02/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr H J T A M Huijbregts
Scientific

University Medical Centre Utrecht (UMCU)
HP F 03.223
P.O. Box 85500
Heidelberglaan 100
Utrecht
3508 GA
Netherlands

Phone +31 (0)30 250 7379
Email R.Huijbregts@azu.nl

Study information

Primary study designInterventional
Study designNon-randomised, non-controlled, parallel group, clinical trial
Secondary study designSingle-centre
Scientific title
Study objectivesResearch 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(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedChronic renal insufficiency
InterventionExcision biopsy of a small piece of the radial artery during operation.
Intervention typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

No secondary outcome measures

Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target sample size at registration30
Key inclusion criteria1. Chronic renal failure and requirement of an arteriovenous fistula
2. Age 18 years or older
3. Informed consent
Key exclusion criteria1. Age less than 18 years
2. Placement of vascular access prosthesis
3. Unable to sign written informed consent
Date of first enrolment01/01/2005
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Centre Utrecht (UMCU)
Utrecht
3508 GA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan