Hemodialysis Access Surveillance Evaluation Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

436 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-07-31

Brief Summary

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The purpose of the study is to learn if monitoring dialysis access blood flow during dialysis treatment with a transonic machine (an ultrasound technique) will prevent (or reduce) the development of dialysis access thrombosis (clotting).

Investigators would like to study if monitoring with a specific technique called ultrasound dilution technique can help prevent problems with access when compared to what is the current standard of care for patients.

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Detailed Description

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Conditions

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Hemodialysis Access Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Surveillance Group

Monthly blood flow surveillance by ultrasound dilution technique and standard of care.

Group Type ACTIVE_COMPARATOR

Transonic

Intervention Type DEVICE

Access recirculation, access flow would be determined using the ultrasound dilution technique (Transonic system).

1. Within 90 min of the beginning of HD session HD03 sensors are clamped HD tubing lines
2. Recirculation, access flow will be performed according to HD03 Manual.
3. Post intervention evaluation is as per each arm follow up unless other follow up deemed necessary by the interventionalist.

Control Group

Control group will receive standard monitoring (standard care).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Transonic

Access recirculation, access flow would be determined using the ultrasound dilution technique (Transonic system).

1. Within 90 min of the beginning of HD session HD03 sensors are clamped HD tubing lines
2. Recirculation, access flow will be performed according to HD03 Manual.
3. Post intervention evaluation is as per each arm follow up unless other follow up deemed necessary by the interventionalist.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Chronic hemodialysis patients undergoing dialysis therapy via an upper extremity arteriovenous access (arteriovenous fistula or an arteriovenous graft) will be enrolled to have monthly surveillance flow measurement using Transonic system or physical examination of the arteriovenous access by qualified person at least once a month for a period of 2 years.

Exclusion Criteria

* Patients requiring surgical intervention on the arteriovenous access.
* History of access thrombosis (one or more access thrombosis of the current arteriovenous access).
* Patients with signs of access infection.
* Patients with a malignancy.
* Patients with life expectancy of less than six months.
* Unable to understand the study.
* Unable to sign the consent form.
* Patients with psychiatric disorder.
* Age less than 18 or greater than 80 years.
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No