Evaluation of Regional Anticoagulation With Citrate in Extended Hemodialysis
Status:
Suspended
Trial end date:
2022-07-31
Target enrollment:
Participant gender:
Summary
Data on regional citrate anticoagulation in patients with acute kidney injury (AKI) treated
by hybrid or extended dialysis are scarce and heterogeneous. The path batch system (Genius®)
or the proportion hemodialysis machines are well suited equipments to perform extended
dialysis. However, clotting of the system might occur with relatively high frequency,
especially in critically ill patients with high risk of clotting or in those with
contraindication to the use of heparin.
The aims of this study are: 1) to test and to validate a new protocol using citrate to
perform regional anticoagulation in AKI patients admitted to the intensive care unit (ICU)
and treated by extended dialysis, using a control group (use of heparin or intermittent
saline flush) as comparison in the Heart Institute of the university medical complex "Clinics
Hospital Medical School at São Paulo" (Hospital das Clínicas da Faculdade de Medicina do
Estado de São Paulo) and at the Cancer Institute of the São Paulo State; 2) to evaluate the
anticoagulation in these procedures with citrate and compare with the control group using
heparin or saline flush, so the primary end point would be the rates of system clotting; 3)
to study the calcium mass transfer in these procedures and its impact on bone metabolism in
these patients. The inclusion criteria are all AKI patients admitted in these places and
candidates to renal replacement therapy using the extended dialysis, age above 18 years. The
exclusion criteria are acute liver failure, hemorrhagic stroke, platelets level below
20,000/mm3, and active bleeding needing transfusional support (two or more red cell packs in
24 hours).
Phase:
Phase 3
Details
Lead Sponsor:
University of Sao Paulo General Hospital
Collaborators:
Hospital do Cancer, Sao Paulo InCor Heart Institute