Improving Outcomes in Vascular Access

NCT02334696 | Terminated

• 1 other identifier: RRK5258
• Study Type: observational
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

The IMPROVA study is designed to identify novel predictors of vascular access success or failure. Clinical assessment complimented by Doppler ultrasound is the only currently employed methods of assessing suitability for placement of arteriovenous fistulae (AVF). These techniques are not capable of predicting vascular access outcomes suggesting that other potentially measurable factors may play a part. Despite efforts to improve placement of AVF in both the haemodialysis incident and prevalent population, many patients continue to dialyse through a central venous catheter (CVC), exposing them to higher risks of infection, co morbidity and mortality than dialysing via an AVF. Furthermore, AVF primary failure rates are reportedly as high in 20-50% in published series confirming that ultrasound cannot inform the clinician sufficiently to accurately predict success or failure. The aim of this study is to perform enhanced assessments of arterial health preoperatively and correlate these measurements with early AVF outcome. We intend to perform pulse wave analysis and velocity; measure advanced glycation end products and assess endothelial function using a vascular occlusion test. We also aim to assess whether patient reported symptoms of hand function can predict AVF outcome. These non-invasive measurements will provide a more accurate picture of overall vascular health prior to AVF formation with the ultimate intention of informing the clinician as to the likelihood of success or failure.

Conditions

End Stage Renal Disease

Keywords

Vascular Access

Outcome Measures

Primary Outcomes (1)

• Early patency

  A successful fistula is defined as any fistula which at early postoperative review shows: Fistula flow rates \>600ml/min Fistula vein diameter \>6mm Distance of fistula vein from skin \<6mm \- 10% allowable for flow rates and vein diameter A failed fistula is defined as any fistula which does not meet this definition.

  2 - 6 weeks

Secondary Outcomes (1)

• Unassisted clinical maturation

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with end stage renal disease referred for assessment in vascular access clinic.

You may qualify if:

• Age 18 years or more. All patients referred to the vascular access clinic. Able to give valid informed consent.

Sponsors & Collaborators

• University Hospital Birmingham: lead

MeSH Terms

Conditions

Kidney Failure, Chronic

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Renal Surgery Consultant

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 8, 2015
• Study Start: January 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 26, 2019

Record last verified: 2019-04