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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Cannulation of permanent dialysis access, for the purpose of delivering continuous renal replacement therapy.
Other interventionPermanent 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
Trial outcomes
Primary outcomes
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
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.
Secondary outcomes
Time on CRRT via AVA
Defined as the time from CRRT initiation via AVA cannulation to CRRT discontinuation. Collected from CRRT flowsheet.
Mean blood flow rate (BFR) achieved during CRRT via AVA
Collected from the CRRT flowsheet and reported in time-weighted mean per patient.
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
Sponsors and contacts
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