Prospective Analysis of Arteriovenous Access (AVA) Use in Continuous Renal Replacement Therapy: A Feasibility Project

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEast Carolina University

About this trial

This study will test whether patients who already have a permanent dialysis access (an arteriovenous fistula or graft) can safely use that access for continuous dialysis (CRRT) while they are critically ill in the intensive care unit, instead of requiring a temporary central venous catheter. About 50 patients will participate. Researchers will monitor how well the access works, whether any complications occur, and whether there are differences between fistulas and grafts. The goal is to determine whether using a patient's existing dialysis access is a safe and practical option that could reduce the need for temporary catheters and their associated risks, such as infection and bleeding.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

ESKD patients on chronic hemodialysis for >1 year in duration who are admitted to the ICU and in need of CRRT.

Anticipated CRRT duration ≥24 hours, based on clinical assessment of the renal trajectory.

Patient with functioning arteriovenous access, either arteriovenous fistula or arteriovenous graft.

Disqualifiers

Age less than 18 years old.

Patients who receive dialysis via hemodialysis catheter or existing central catheter suitable for hemodialysis.

ESKD patients who, at the time of enrollment, have a sacral pressure ulcer or other clinically significant skin integrity impairment requiring frequent repositioning, extensive patient rotation, or advanced wound care management.

Patients with elevated INR above 5 at the time of study enrollment.

Trial design

Design model

Single group

Treatments tested in this trial

  • Cannulation of permanent dialysis access, for the purpose of delivering continuous renal replacement therapy.

    Other intervention

    Permanent dialysis access, including arteriovenous fistulas or grafts, will be cannulated using standard dialysis needles for the purpose of delivering continuous renal replacement therapy. CRRT via arteriovenous access will only be performed in ICU settings where nursing staff have at least one year of ICU experience and have completed both study-specific training and institutional CRRT training. Dialysis nurses will perform cannulation of the arteriovenous access according to the standardized operating procedure.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Patients with end-stage kidney disease (ESKD) requiring continuous renal replacement therapy (CRRT).Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Technical Feasibility of using Arteriovenous Access for CRRT delivery

AVA viability upon discontinuation of the first CRRT run. AVA viability will be determined by functional access for subsequent dialysis, confirmed within 24-48 hours after discontinuation of the first CRRT run by the presence of a thrill and/or bruit on physical examination and post-CRRT flow studies showing less than a 25% reduction from baseline

Time frame
From initiation of CRRT until discontinuation of CRRT, ICU discharge or 7 days post-CRRT (whichever occurs first), and 30 days post-CRRT via chart review.
2

Access-related serious complications

Serious complications will include any of the following: major bleeding event, needle dislodgement with hemodynamic compromise, access thrombosis requiring intervention, death related to AVA complications, acute limb ischemia related to AVA or permanent loss of AVA function attributable to study participation.

Time frame
From initiation of CRRT until discontinuation of CRRT, ICU discharge or 7 days post-CRRT (whichever occurs first), and 30 days post-CRRT via chart review.

Secondary outcomes

1

Time on CRRT via AVA

Defined as the time from CRRT initiation via AVA cannulation to CRRT discontinuation. Collected from CRRT flowsheet.

Time frame
From initiation of CRRT until discontinuation of CRRT, ICU discharge or 7 days post-CRRT (whichever occurs first), and 30 days post-CRRT via chart review.
2

Mean blood flow rate (BFR) achieved during CRRT via AVA

Collected from the CRRT flowsheet and reported in time-weighted mean per patient.

Time frame
From initiation of CRRT until discontinuation of CRRT, ICU discharge or 7 days post-CRRT (whichever occurs first), and 30 days post-CRRT via chart review.
3

Minor AVA Complications

Reported per patient, both individually and as a composite. Minor complications comprise any of the following during the first CRRT run: persistent low blood flow rate (\< 150 mL/min for ≥ 20 minutes despite troubleshooting, access-site hematoma not requiring intervention; access-site infection, aneurysm or pseudoaneurysm formation, and needle dislodgement without hemodynamic compromise

Time frame
From initiation of CRRT until discontinuation of CRRT, ICU discharge or 7 days post-CRRT (whichever occurs first), and 30 days post-CRRT via chart review.

Other outcomes

Sponsors and contacts

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