Prospective Analysis of Arteriovenous Access (AVA) Use for Continuous Renal Replacement Therapy (CRRT)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEast Carolina University
About this trial
Arteriovenous fistula or graft are the ideal hemodialysis access. Nonetheless the most common access type used for Continuous Renal Replacement Therapy (CRRT) is either a temporary or permanent hemodialysis catheter. Recommendations for the use of catheters to deliver CRRT in end stage kidney disease (ESKD) patients are lacking on data and subjective to anecdotal experiences and expert consensus. The repetitive placement of catheters in ESKD patients have shown to increase the chances of central vascular stenosis which is one of the main risk factors that lead to access failure. Also, the repetitive use of dialysis catheters increases the risk for catheter associated infections. Dedicated studies demonstrating the safety and feasibility of using arteriovenous access (AVA) for CRRT are scarce. No screening criteria or algorithm exists to determine the adequate patient and clinical scenario to use AVA for CRRT.
Goals of the study:
1. To develop a standard operating procedure for the use of AVA in CRRT. 2. Evaluate the safety and efficacy of using AVA for CRRT.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Diagnosis of End-Stage Kidney Disease (ESKD) receiving maintenance chronic hemodialysis
Admission to the Intensive Care Unit (ICU)
Presence of a functioning arteriovenous fistula (AVF) or arteriovenous graft (AVG)
Disqualifiers
Age under 18 years
Arteriovenous access thrombectomy within 30 days prior to study enrollment
Documented prolonged bleeding from arteriovenous access within 30 days prior to study enrollment
Current dialysis via temporary or tunneled hemodialysis catheter
Trial population
End stage kidney disease patients requiring CRRT in the intensive care unit.
Trial design
Design model
Cohort
Time perspective
Prospective
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
50 Participants
are divided into 1 treatment groupGroup A: Patients with end-stage kidney disease (ESKD) requiring continuous renal replacement therapy (CRRT).1 intervention
Trial outcomes
Primary outcomes
1
Access survival
Access survival, defined as continued usability of the AV access without thrombosis, major complication, or need for temporary catheter placement.
Time frame
From initiation of CRRT until discontinuation of CRRT, occurrence of access failure (defined as thrombosis, major access-related complication, or need for temporary dialysis catheter placement), ICU discharge, or up to 30 days after CRRT initiation.Sponsors and contacts
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Source ClinicalTrials.gov
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