Evaluation of Regional Anticoagulation With Citrate in Extended Hemodialysis

• Status: Suspended
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo General Hospital
• Collaborators: Hospital do Cancer, Sao Paulo; InCor Heart Institute
• Treatments: Calcium heparin; Citric Acid; Heparin; Sodium Citrate

Criteria

Inclusion Criteria:

• All patients with acute kidney injury admitted to the intensive care unit and candidates for extended dialysis (renal replacement therapy)

• Age over 18 years.

Exclusion Criteria:

• Acute liver failure

• Hemorrhagic stroke in the last 30 days

• Patients with platelet levels below 20,000/mm3

• Active bleeding requiring transfusion (two or more red blood cell packs within 24 hours)