Evaluation of Regional Anticoagulation With Citrate in Extended Hemodialysis

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).

Conditions

• Hemodialysis Complication
• Acute Kidney Injury
• Anticoagulant Toxicity

Interventions

DRUG

Citrate Anticoagulation Solution

Regional citrate anticoagulation in extended hemodialysis sessions compared to the standard of care actually performed in these therapies (heparin or continuous saline infusion)

DRUG

Control Group (heparin or continuous saline)

Use of heparin in hemodialysis sessions. If there is any contraindication against the use of heparina, the investigators will perform saline flush of the dialysis system

Sponsors & Collaborators

• InCor Heart Institute

  collaborator OTHER

• Hospital do Cancer, Sao Paulo

  collaborator OTHER

• University of Sao Paulo General Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-12

Primary Completion

2022-07-31

Completion

2022-07-31

FDA Drug

Yes

Countries

• Brazil

Study Locations