Improving Arteriovenous Fistula Patency

NCT02111655 | Completed DMC

• 2 other identifiers: 210443-031132-2612333598
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 5

Brief Summary

All vascular access guidelines recommend monitoring and surveillance protocols to prevent vascular access complications in hemodialysis units. However, in the case of second generation screening techniques which determine access blood flow measurement (QA), there is a huge controversy about it´s efficiency. Although multiple observational studies find a decrease in the thrombosis rate and an increased primary assisted patency survival related to the use of these techniques, a recently published meta-analysis find contradictory results in the randomized controlled trials, affirming that the measurement of QA is useless in grafts and questionable in native arteriovenous fistulae (AVF). We have designed a multicenter, prospective, open label, controlled, randomized trial, to prove the usefulness of the QA measurement using two complementary second generation techniques, Doppler ultrasound and Transonic dilution method, compared to the classical monitoring and surveillance methods. The primary endpoint will be a reduction in the thrombosis rate with an increased assisted primary patency survival, and a cost effectiveness economic analysis. As secondary endpoints we will analyze the impact over non-assisted primary patency survival and secondary patency survival.

Conditions

Thrombosis

Keywords

Thrombosis; Arteriovenous fistulae; Hemodialysis; Doppler ultrasound; Vascular access blood flow; Surveillance

Outcome Measures

Primary Outcomes (1)

• Improved primary patency rate in arteriovenous fistulae with the use of doppler ultrasound and transonic dilution method

  Differences in assisted primary patency rates (thrombosis free access survival) in AVF between the two groups: control group in which classical monitoring and surveillance techniques are applied and experimental group in which Doppler ultrasound and transonic were performed every three months in addition to classical methods. Cost efficacy analysis in both groups will be done, measuring all vascular access (VA) related health care spending (VA hospitalization costs, central venous catheter (CVC) placements, surgeries and endovascular procedures will be recorded).

  Up to 3 years follow up

Secondary Outcomes (7)

• Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups.

  Up to 1 year follow up

• Evaluate the efficacy and efficiency of second generation methods

  Up to 2 years follow up

• Reproducibility in Doppler ultrasound technique

  Up to 3 years follow up.

• Possible influence of different baseline items in the risk of thrombosis of native AVF

  Up to 3 years follow up

• Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups.

  Up to 2 years follow up

Study Arms (2)

Clasical Surveillance of AVF

OTHER

Classical evaluation of AVF includes: 1. Vital sings and predialysis physical examination of AVF every dialysis session. 2. Effective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session. 3. Weekly ktv test using biosensors or monthly if using monocompartimental Daugirdas equation. 4. Quarterly recirculation with urea method. Following Spanish Nephrology VA guidelines will be consider as alarm criteria: 1.25% Increased venous pressure. 2.25% Decreased pump blood flow. 3.0,2 ktv decreased compared with previous measurement. 4.\> 10% recirculation using urea method. 5.Prolonged coagulation time or cannulation difficulties in 3 consecutive dialysis sessions. 6.Pathologic physical examination with any other criteria.

Procedure: vital signs; Procedure: physical examination of AVF; Procedure: ktv test; Procedure: urea method

Second generation surveillance of AVF

EXPERIMENTAL

In addition to the classical surveillance and monitoring methods, in the experimental group Doppler ultrasound and transonic dilution method will be performed on a quarterly basis. In addition to the classical alarm criteria and derived from the results in Doppler ultrasound an transonic dilution method the following alarm criteria would also be considered in the experimental group: 1. 25% or higher decreased in QA compared with previous measurement. 2. QA lower than 500 ml/min. 3. Stenotic area with a higher than 50% reduction of blood vessel lumen would be considered as alarm criteria only if it comes with a haemodynamic repercussion criteria defined as Peak systolic velocity (PSV) higher than 400 cm/sc, aliasing, or PSV ratio stenosis/pre-stenosis higher than 3.

Device: Second generation surveillance of AVF; Procedure: vital signs; Procedure: physical examination of AVF; Procedure: ktv test; Procedure: urea method

Interventions

Second generation surveillance of AVF DEVICE

Doppler ultrasound and transonic dilution method technique will be performed in the experimental group quarterly. QA will be measured by both techniques and haemodynamic repercussion stenosis will be evaluated by doppler ultrasound.

Also known as: Doppler ultrasound: M-Turbo. Sonosite., Transonic dilution method: Transonic System Inc HD-03

Second generation surveillance of AVF

vital signs PROCEDURE

Effective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session

Clasical Surveillance of AVF; Second generation surveillance of AVF

physical examination of AVF PROCEDURE

Predialysis physical examination of AVF every dialysis session.

Clasical Surveillance of AVF; Second generation surveillance of AVF

ktv test PROCEDURE

Weekly ktv measurement using biosensors. In patients who have been dialyzed in monitors with no biosensors, ktv will be measured monthly using monocompartimental Daugirdas equation

Clasical Surveillance of AVF; Second generation surveillance of AVF

urea method PROCEDURE

Quarterly recirculation with urea method.

Clasical Surveillance of AVF; Second generation surveillance of AVF

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent signature.
• Age between 18 and 95 years old.
• Functioning native AVF.
• Patients with end stage renal disease (ESRD) undergoing hemodialysis program for at least three months.

You may not qualify if:

• Coagulopathy or hemoglobinopathy of any cause.
• Hospitalization of any cause in the previous month.
• VA related complications or dysfunction in the previous three months.

Sponsors & Collaborators

• Hospital Infanta Sofia: lead

Study Sites (5)

Hospital Universitario Infanta Sofia

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

Centro de Diálisis Los Enebros

Madrid, 28007, Spain

Location

Hospital Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Dialcentro

Madrid, 28009, Spain

Location

Clinica Fuensanta

Madrid, 28027, Spain

Location

Related Publications (2)

• Aragoncillo I, Abad S, Caldes S, Amezquita Y, Vega A, Cirugeda A, Moratilla C, Ibeas J, Roca-Tey R, Fernandez C, Macias N, Quiroga B, Blanco A, Villaverde M, Ruiz C, Martin B, Ruiz AM, Ampuero J, de Alvaro F, Lopez-Gomez JM. Adding access blood flow surveillance reduces thrombosis and improves arteriovenous fistula patency: a randomized controlled trial. J Vasc Access. 2017 Jul 14;18(4):352-358. doi: 10.5301/jva.5000700. Epub 2017 Apr 20.

  PMID: 28430315 DERIVED

• Aragoncillo I, Amezquita Y, Caldes S, Abad S, Vega A, Cirugeda A, Moratilla C, Ibeas J, Roca-Tey R, Fernandez C, Quiroga B, Blanco A, Villaverde M, Ruiz C, Martin B, Ruiz AM, Ampuero J, Lopez-Gomez JM, de Alvaro F. The impact of access blood flow surveillance on reduction of thrombosis in native arteriovenous fistula: a randomized clinical trial. J Vasc Access. 2016 Jan-Feb;17(1):13-9. doi: 10.5301/jva.5000461. Epub 2015 Sep 18.

  PMID: 26391583 DERIVED

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• ANTONIO CIRUGEDA, MD

  HOSPITAL UNIVERSITARIO INFANTA SOFIA

  PRINCIPAL INVESTIGATOR

• SILVIA CALDES, MD

  HOSPITAL UNIVERSITARIO INFANTA SOFIA

  STUDY CHAIR

• YESIKA AMEZQUITA, MD

  CLINICA FUENSANTA

  STUDY CHAIR

• JUAN MANUEL LOPEZ, PhD

  HOSPITAL UNIVERSITARIO GREGORIO MARAÑON

  STUDY CHAIR

• SORAYA ABAD, MD

  HOSPITAL UNIVERSITARIO GREGORIO MARAÑON

  STUDY CHAIR

• INES ARAGONCILLO, MD

  Hospital Infanta Sofia

  STUDY CHAIR

• BORJA QUIROGA, MD

  HOSPITAL GREGORIO MARAÑON

  STUDY CHAIR

• FERNANDO DE ALVARO, PhD

  Hospital Infanta Sofia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 11, 2014
• Study Start: September 1, 2012
• Primary Completion: September 29, 2015
• Study Completion: September 29, 2015
• Last Updated: June 20, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)