Regional Citrate Anticoagulation for RRT During V-V ECMO

Not Applicable

Recruiting

• Conditions: ARDS, Human; Acute Kidney Injury
• Interventions: Drug: Unfractionated heparin first; Drug: Unfractionated heparin + RCA first

• Registration Number: NCT05148026
• Lead Sponsor: University of Milano Bicocca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-26
• Study Start: 2021-11-14
• Study First Submitted QC: 2021-11-23
• Study First Posted: 2021-12-08
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-10-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Anticoagulation sequence 1 (UFH+ RCA)	Unfractionated heparin first	UFH+ RCA first
Anticoagulation sequence 2 (UFH)	Unfractionated heparin + RCA first	UFH first

Primary Outcome Measures

Name	Time	Method
Incidence of CRRT circuit clotting according to anticoagulation regimen	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 Outcome Measures

Name	Time	Method
CRRT circuit "survival" analysis	According to the manufacturer recommendation elective RRT circuit replacement will be performed after 72 hours of circuit life.	"Circuit life" of RRT circuits in the intervention group (RCA+UFH) vs controls (UFH), comparison between groups will be performed as time to event(clotting) by log-rank test and described by the kaplan meier approach. Circuit replacement for other reasons (e.g. transfer to radiology to undergo a CT scan) will be right censored
Comparison of platelets count, D-dimers, fibrinogen	72 hours for each circuit	Comparison of lab values of blood sampled during intervention (RCA+UFH) vs control (UFH). Values will be compared as absolute value and as a difference compared to each circuit baseline
Incidence of citrate anticoagulation side-effects	72 hours for each circuit	Total to ionized calcium ratio (marker of citrate accumulation), rate of hypersodiemia and alkalosis will be compared between intervention (RCA+UFH) and control (UFH)
To evaluate the anticoagulation effects of UFH and RCA	72 hours for each circuit	TEG analysis of blood samples with UFH vs UFH+RCA effect will be compared. Specifically, TEG R-time will be compared in blood sampled from circuit anti-coagulated with RCA+UFH vs UFH only

Trial Locations

Locations (1)

ASST MONZA-Rianimazione Generale; 🇮🇹 Monza, Italy