An interventional study of Cannulation of permanent dialysis access, for the purpose of delivering continuous renal replacement therapy. in Continuous Renal Replacement Therapy (CRRT) and End Stage Kidney Disease (ESRD), sponsored by East Carolina University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by East Carolina University · Not applicable, Interventional, and Other
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.
Synopsis: This is a single-arm, single-center, pragmatic prospective study evaluating the safety and feasibility of using existing arteriovenous access (arteriovenous fistulas or arteriovenous grafts) to deliver continuous renal replacement therapy in critically ill end-stage kidney disease patients admitted to the intensive care unit. A target of 50 patients will be enrolled consecutively. The study intervention consists of CRRT delivery via AVA using standard steel hemodialysis needles (14-17 gauge) with continuous bedside monitoring by ICU nursing staff and dialysis nurse support for cannulation and decannulation. Data will be collected from the electronic health record, structured CRRT flowsheets, standardized monitoring checklists, and bedside ultrasound flow studies performed at baseline and upon CRRT discontinuation. Primary analyses will include descriptive statistics for access viability rates and complication frequencies, with exploratory subgroup analysis by access type. An independent Data Safety Monitoring Board will provide continuous safety oversight with pre-specified stopping rules.
Objectives: This study evaluates the safety and feasibility of using arteriovenous access (AVA) to deliver continuous renal replacement therapy (CRRT) in critically ill patients with end-stage kidney disease (ESKD). By utilizing existing permanent vascular access, this intervention seeks to minimize central venous catheter exposure and its associated complications. The primary aims are to investigate the technical feasibility of using AVA for the first CRRT run (Aim 1) and to evaluate the safety via serious complications associated with AVA use (Aim 2) in ESKD patients admitted to the ICU. Finally, feasibility and safety outcomes will also be summarized by access type, separately for participants with arteriovenous fistulas (AVFs) and arteriovenous grafts (AVGs) (Aim 3).
Endpoints: The primary endpoint for feasibility is AVA viability for subsequent dialysis upon discontinuation of the first CRRT run, defined as functional access confirmed within 24-48 hours by the presence of thrill and/or bruit and post-CRRT flow studies showing less than 25% reduction from baseline. The primary endpoint for safety is access-related serious complications per patient, including major bleeding, access thrombosis requiring intervention, acute limb ischemia, or death related to AVA. Secondary feasibility endpoints include time on CRRT via AVA and mean blood flow rate achieved during CRRT. Secondary safety endpoints include minor access-related complications. All endpoints will additionally be summarized descriptively by access type (AVF vs. AVG) as an exploratory analysis.
Population: 50 adult patients (≥18 years), all genders, with ESKD on chronic hemodialysis for >1 year, admitted to the ICU with a functioning AVF or AVG, requiring CRRT, mechanically ventilated with an expected RASS of 0 or less. Enrollment will require agreement from both the prescribing nephrologist and the ICU physician that AVA use for CRRT is clinically appropriate and safe for the individual patient. Patients with significant coagulopathy, acute liver failure, high risk for rapid clinical deterioration, or those deemed unsuitable for AVA-based CRRT by the prescribing nephrologist or ICU attending will be excluded. Additionally, the prescribing nephrologist and ICU attending will retain the authority to discontinue the intervention at any time based on clinical judgment.
Phase: Investigator-initiated feasibility study; no investigational drug or device.
Number of Sites Enrolling Participants: 1 (ECU Health Medical Center, Greenville, NC).
Description of Study Intervention: The intervention involves the use of an existing, mature arteriovenous access (AVF or AVG) for CRRT delivery in lieu of standard non-tunneled dialysis catheter placement. AVA cannulation is performed using standard steel hemodialysis needles (14-17 gauge) by certified dialysis nurses. These needles are FDA-cleared for intermittent hemodialysis; however, their use in this protocol involves prolonged dwell times during continuous therapy, which falls outside the manufacturer's cleared labeling. As such, this application represents an off-label use of a cleared device, and systematic documentation of needle dwell duration is a component of this study. CRRT is delivered via the institutional CRRT platform (CVVH or CVVHD) at blood flow rates of 150-300 mL/min and effluent doses of 20-40 mL/kg/hour per nephrologist prescription. No investigational drugs or biologics are used.
Study Duration: Approximately 20 months (14 months enrollment plus 6 months for final follow-up completion, data cleaning, and analysis).
Participant Duration: Approximately 1 month. Active study participation spans from enrollment through CRRT discontinuation (variable, typically days), with follow-up assessments at CRRT discontinuation (ultrasound within 24-48 hours), ICU discharge or 7 days post-CRRT (whichever occurs first), and 30 days post-CRRT via chart review.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 50 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →East Carolina University is the lead sponsor of 84 studies on the registry; 13 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort will include adult patients with end-stage kidney disease (ESKD) receiving chronic outpatient hemodialysis who are admitted to the Intensive Care Unit (ICU) and require continuous renal replacement therapy (CRRT). Eligible participants must have a mature, functional permanent vascular access used for outpatient hemodialysis, defined as either a functioning arteriovenous fistula (AVF) or a functioning arteriovenous graft (AVG). Patients must meet the inclusion and exclusion criteria prior to enrollment.
Other: Cannulation of permanent dialysis access, for the purpose of delivering continuous renal replacement therapy.
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.
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.
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.
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.
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.
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.
Plan to share: No
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