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

NCT07447128 | Not Yet Recruiting DMC

• 1 other identifier: 25-001142
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Continuous Renal Replacement Therapy (CRRT); End Stage Kidney Disease (ESRD)

Keywords

Arteriovenous access; Continuous Renal Replacement Therapy; CRRT; AVA; ESKD; End Stage Kidney Disease

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  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 (3)

• Time on CRRT via AVA

  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

  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

  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.

Study Arms (1)

Patients with end-stage kidney disease (ESKD) requiring continuous renal replacement therapy (CRRT).

EXPERIMENTAL

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.

Interventions

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

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.

Patients with end-stage kidney disease (ESKD) requiring continuous renal replacement therapy (CRRT).

Eligibility Criteria

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

You may qualify if:

• 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.
• Expected mechanical ventilation for a minimum of 12 hours, based on clinical assessment of the underlying diagnosis.
• Expected Richmond Agitation Sedation Scale (RASS) goal of 0 or less for a minimum of 12 hours, based on clinical assessment of the underlying diagnosis.
• Patients able to tolerate placement of an arm board at the vascular access site.
• Baseline AVA blood flow of at least 600 mL/min for AVG and 500 mL/min for AVF during ultrasonography evaluation upon enrollment.

You may not qualify if:

• 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.
• Patients with acute liver failure, defined as AST \>1000 U/L and/or ALT \>1000 U/L at the time of study enrollment.
• Patients with a platelet count of less than 50,000 (10⁹ plt/L) at the time of study enrollment.
• Patients with evidence of disseminated intravascular coagulation at the time of study enrollment.
• Known pregnancy at the time of study enrollment.
• Patients at high risk for rapid clinical deterioration, or those deemed unsuitable for AVA-based CRRT by the prescribing nephrologist or ICU physician.

Sponsors & Collaborators

• East Carolina University: lead

Study Sites (1)

East Carolina University Medical Center

Greenville, North Carolina, 27834, United States

Location

Related Publications (3)

• Lok CE, Huber TS, Lee T, Shenoy S, Yevzlin AS, Abreo K, Allon M, Asif A, Astor BC, Glickman MH, Graham J, Moist LM, Rajan DK, Roberts C, Vachharajani TJ, Valentini RP; National Kidney Foundation. KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update. Am J Kidney Dis. 2020 Apr;75(4 Suppl 2):S1-S164. doi: 10.1053/j.ajkd.2019.12.001. Epub 2020 Mar 12.

  PMID: 32778223 BACKGROUND

• Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.

  PMID: 22890468 BACKGROUND

• Al Rifai A, Sukul N, Wonnacott R, Heung M. Safety of arteriovenous fistulae and grafts for continuous renal replacement therapy: The Michigan experience. Hemodial Int. 2018 Jan;22(1):50-55. doi: 10.1111/hdi.12550. Epub 2017 Mar 13.

  PMID: 28295984 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Armando F Rodriguez Lopez, MD

  ECU Health Medical Center

  PRINCIPAL INVESTIGATOR

• Iskra Myers, MD

  ECU Health Medical Center

  STUDY DIRECTOR

Central Study Contacts

Armando Rodriguez Lopez, MD

CONTACT

+19392750483; rodriguezlopeza23@ecu.edu

Iskra Myers, MD

CONTACT

914-282-4448; myersi20@ecu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in Medicine

Study Record Dates

• First Submitted: February 21, 2026
• First Posted: March 3, 2026
• Study Start: July 27, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)