Regional Citrate Anticoagulation for RRT During V-V ECMO (CRRT ECMO)

University of Milano Bicocca

Status: Enrolling

Conditions: Acute Kidney Injury; ARDS, Human

Treatments: Drug: Unfractionated heparin first; Drug: Unfractionated heparin + RCA first

Study type: Interventional

Funder types: Other

Identifiers

NCT05148026

3732

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Anticoagulation sequence 1 (UFH+ RCA)

Active Comparator group

Description:

UFH+ RCA first

Treatment:

Drug: Unfractionated heparin first

Anticoagulation sequence 2 (UFH)

Active Comparator group

Description:

UFH first

Treatment:

Drug: Unfractionated heparin + RCA first