Regional Citrate Anticoagulation for Continuous Renal Replacement Therapy During Veno-venous ECMO: a Crossover Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Milano Bicocca
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Incidence of CRRT circuit clotting according to anticoagulation regimen
Study Overview
Brief Summary
Anticoagulation is an essential component of all extracorporeal therapies. Currently locoregional citrate anticoagulation is the recommended technique for continuous renal replacement therapy (CRRT).
However, low clearance of citrate restricts its use to blood flow up to 150 mL/min, preventing its use in ECMO.
Renal replacement therapy (RRT) is commonly provided to ECMO patients with AKI. In presence of systemic heparinization for ECMO, additional anticoagulation for the CRRT circuit (i.e. RCA) is usually not employed.
Nevertheless, thrombosis occurs more frequently in the CRRT circuit than the oxygenator because of the slower blood flow.
The aim of this prospective, cross-over study is to assess, in patients undergoing CRRT during veno-venous ECMO (vv-ECMO), the efficacy and safety of adding regional citrate anticoagulation (RCA) for CRRT circuit anticoagulation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients admitted in ICU
- •V-V ECMO support for acute respiratory failure
- •CRRT therapy for acute kidney injury
Exclusion Criteria
- •Pregnancy
- •Pre-existing coagulation disorders
- •Contraindication to heparin or citrate anticoagulation
- •Moribund patients
Arms & Interventions
Anticoagulation sequence 1 (UFH+ RCA)
UFH+ RCA first
Intervention: Unfractionated heparin first (Drug)
Anticoagulation sequence 2 (UFH)
UFH first
Intervention: Unfractionated heparin + RCA first (Drug)
Outcomes
Primary Outcomes
Incidence of CRRT circuit clotting according to anticoagulation regimen
Time Frame: According to the manufacturer recommendation elective RRT circuit replacement will be performed after 72 hours of circuit life.
Rate of clotting in the intervention group (RCA+UFH) vs controls (UFH). I.e. : did the circuit clot in its 72h life?
Secondary Outcomes
- CRRT circuit "survival" analysis(According to the manufacturer recommendation elective RRT circuit replacement will be performed after 72 hours of circuit life.)
- Comparison of platelets count, D-dimers, fibrinogen(72 hours for each circuit)
- Incidence of citrate anticoagulation side-effects(72 hours for each circuit)
- To evaluate the anticoagulation effects of UFH and RCA(72 hours for each circuit)
Investigators
Marco Giani
Research Collaborator
University of Milano Bicocca