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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-2z9xyb |
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Date of registration:
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13/02/2012 |
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Primary sponsor: |
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Public title:
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Use of citrate content dialysate in patients on hemodialysis
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Scientific title:
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Effects of the use of citrate content dialysate on the extracorporeal anticoagulation in maintenance hemodialysis |
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Date of first enrolment:
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01/07/2011 |
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Target sample size:
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30 |
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Recruitment status: |
recruiting |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-2z9xyb/ |
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Study type:
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Study design:
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Clinical trial, crossover, 2 arms, open, phase 4.
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Amanda
Rocha |
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Address:
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Avenida Marques de Paraná 303, 2°andar
24030-215
Niterói
Brazil |
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Telephone:
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(0xx)21 2629-9000 |
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Email:
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rocha_ad@yahoo.com.br |
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Affiliation:
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Divisão de Nefrologia da Faculdade de Medicina da Universidade Federal Fluminense |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients older than 18 years of age, both genders, on maintenance hemodialysis, without major comorbidities.
Exclusion criteria: Prescription of hemodialysis shorter than 3h 30 min.
Use of oral anticoagulant.
Use of temporary double lumen catheter.
Awating for living donor kidney transplant.
Refuse to participate.
Age minimum:
18Y
Age maximum:
0
Gender:
-
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Health Condition(s) or Problem(s) studied
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Chronic kidney disease
N18.0
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N00-N99
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Intervention(s)
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Patients will be randomized to undergo to 12 consecutive dialysis sessions in each arm:
A) Hemodialysis using 4.0 mEq/L acetate buffer dialisate and heparin dose 100 IU/Kg.
B) Hemodialysis using 2.4 mEq/L citrate buffer dialisate and heparin dose 70 IU/Kg.
There will be a wash-out period between the phases with standard prescription of dialysis for 6 sessions.
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Primary Outcome(s)
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Loss of the dialyzer before 12th use due to clotting of blood in the extracorporeal circuit or reduction of fiber bundle volume >20% of baseline.
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Secondary Outcome(s)
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Reduction of hemodialysis efficiency assessed by the urea Kt/V at 1st, 6th and 12th dialysis sessions of each phase.
Incidence of hypocalcemia or hypomagnesemia in each phase of the study.
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Secondary ID(s)
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CAAE 0150.0.258.258-11
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Source(s) of Monetary Support
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Fundação Aloísio de Paula - Brazil
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