Acute Kidney Injury, ARDS, Human
Conditions
Keywords
Extracorporeal Membrane Oxygenation, Acute Kidney Injury, ARDS, Renal Replacement Therapy
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.
Interventions
DRUGUnfractionated heparin + RCA first
Patients are randomized to receive this sequence of anticoagulation regimens: UFH+RCA / UFH / UFH+RCA / UFH / UFH+RCA / UFH
DRUGUnfractionated heparin first
Patients are randomized to receive this sequence of anticoagulation regimens: UFH / UFH+RCA / UFH / UFH+RCA / UFH / UFH+RCA
Sponsors
University of Milano Bicocca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed