NCT01704313

Brief Summary

Patients with end-stage renal failure require dialysis to remove toxins from their blood. Haemodialysis is best provided through a native arterio-venous fistula (AVF). Creation of an AVF requires a short (\~1hr) surgical procedure to join the artery and vein together. There are limited potential sites for fistula creation. Generally it is preferrable to utilise the most distal sites at the wrist first, as more proximal elbow procedures preclude subsequent use of the wrist should the initial fistula fail. The small diameter of artery and vein at the wrist requires precise surgical technique. There are two potential techniques in common use for creating the arterio-venous anastomosis (the join between artery and vein) - continuous suturing and interrupted sutures. Whilst there are theoretical advantages to the interrupted technique, it is uncertain if these translate clinically into better success of creating the fistula. The aim of this study is therefore to compare the clinical success of the two techniques.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

October 11, 2012

Status Verified

October 1, 2012

Enrollment Period

1.3 years

First QC Date

October 8, 2012

Last Update Submit

October 10, 2012

Conditions

End Stage Renal Failure

Keywords

Vascular accessHaemodialysisSuturing technique

Outcome Measures

Primary Outcomes (1)

  • Primary patency

    Primary patency is defined by the unequivocal presence of a thrill/ bruit and unassisted maturation a to permit dialysis

    6 weeks

Secondary Outcomes (2)

  • Secondary patency

    6 weeks, 1 year

  • Primary patency

    1 year

Study Arms (2)

Interrupted

EXPERIMENTAL

Interrupted suturing technique used around heel of anastomosis

Procedure: Interrupted

Continuous

ACTIVE COMPARATOR

Continuous suturing technique used for the anastomosis

Procedure: Continuous

Interventions

InterruptedPROCEDURE

Interrupted suturing technique used aroudn the heel of the vascular anastomosis

Interrupted
ContinuousPROCEDURE

Continuous suturing technique used for the anastomosis

Continuous

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • End stage renal failure
  • Undergoing surgery for creation of a radiocephalic fistula

You may not qualify if:

  • Declines participation
  • Unable to speak English or provide informed consent
  • Radial artery diameter \<1.8mm
  • Cephalic wrist diameter at wrist \<2mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Renal Surgery, Western Infirmary

Glasgow, G116NY, United Kingdom

RECRUITING

Related Publications (1)

  • Aitken E, McColl G, Kingsmore D. The Role of Qutenza(R) (Topical Capsaicin 8%) in Treating Neuropathic Pain from Critical Ischemia in Patients with End-Stage Renal Disease: An Observational Cohort Study. Pain Med. 2017 Feb 1;18(2):330-340. doi: 10.1093/pm/pnw139.

    PMID: 28204726DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David B Kingsmore, MBChB FRCS

    NHS Greater Glasgow and Clyde

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma L Aitken, MBChB

CONTACT

01412111750EmmaAitken@nhs.net

David B Kingsmore, MBChB FRCS

CONTACT

01412111750david.kingsmore@ggc.scot.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Research Fellow, Renal Surgery

Study Record Dates

First Submitted

October 8, 2012

First Posted

October 11, 2012

Study Start

May 1, 2012

Primary Completion

August 1, 2013

Study Completion

May 1, 2014

Last Updated

October 11, 2012

Record last verified: 2012-10

Locations

GB(1)