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Completed

NCT Number: NCT05148026

Regional Citrate Anticoagulation for RRT During V-V ECMO

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.

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Key information

Conditions

ARDS, Human Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Lung Diseases Male Urogenital Diseases Renal Insufficiency Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ASST MONZA-Rianimazione Generale

Monza, Italy, 20900

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unfractionated heparin + RCA first

Drug

Patients are randomized to receive this sequence of anticoagulation regimens: UFH+RCA / UFH / UFH+RCA / UFH / UFH+RCA / UFH

Other names: Start with CVVHD, BF 100-120 ml/min, dialysate 2000 ml/h, RCA + systemic anticoagulation

Unfractionated heparin first

Drug

Patients are randomized to receive this sequence of anticoagulation regimens: UFH / UFH+RCA / UFH / UFH+RCA / UFH / UFH+RCA

Other names: Start with CVVHD, BF 200 ml/h, dialysate 2000 ml/h, systemic anticoagulation only

Primary outcomes

  1. 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

  1. CRRT circuit "survival" analysis

    Time frame: 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

  2. Comparison of platelets count, D-dimers, fibrinogen

    Time frame: 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

  3. Incidence of citrate anticoagulation side-effects

    Time frame: 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)

  4. To evaluate the anticoagulation effects of UFH and RCA

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Registry information

Official study title

Regional Citrate Anticoagulation for Continuous Renal Replacement Therapy During Veno-venous ECMO: a Crossover Randomized Controlled Study

Acronym: CRRT ECMO

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 8, 2021
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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