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

January 24, 2023 updated by: Marco Giani, University of Milano Bicocca

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Monza, Italy, 20900
        • Recruiting
        • ASST MONZA-Rianimazione Generale
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anticoagulation sequence 1 (UFH+ RCA)
UFH+ RCA first
Drug: Unfractionated heparin first
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
Active Comparator: Anticoagulation sequence 2 (UFH)
UFH first
Drug: Unfractionated heparin + RCA first
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?
According to the manufacturer recommendation elective RRT circuit replacement will be performed after 72 hours of circuit life.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
72 hours for each circuit
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)
72 hours for each circuit
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
72 hours for each circuit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milano Bicocca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2021

Primary Completion (Anticipated)

October 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

October 26, 2021

First Submitted That Met QC Criteria

November 23, 2021

First Posted (Actual)

December 8, 2021

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3732

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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