Status:
UNKNOWN
Benefits of Hemodialysis With Citrate (ABC-treat) Study
Lead Sponsor:
Fundación Senefro
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Hemodialysis-Induced Symptom
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Prospective randomized cross-over multicenter study to demonstrate the benefits of hemodialysis without acetate dialysate, with citrate. 32 weeks duration, in two phases. In the first, half of the pa...
Detailed Description
Primary objective: to analyze the effect of citrate dialysate on acid base balance decreasing chronic metabolic acidosis and avoiding / reducing post-dialytic alkalosis. Secondary objectives: * Eval...
Eligibility Criteria
Inclusion
- Outpatient conventional hemodialysis three times per week for at least three months.
- Arteriovenous fistula as vascular access
- Patients who have given their informed consent in writing.
Exclusion
- Catheter as vascular access
- Allergy or intolerance to citrate
- Patients with sufficient cognitive impairment that would prevent the compression of information and informed consent.
- Inflammatory intercurrent diseases (chronic infections, autoimmune diseases or tumors) that can mask the results of the study.
Key Trial Info
Start Date :
May 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03319680
Start Date
May 1 2016
End Date
December 1 2017
Last Update
October 24 2017
Active Locations (12)
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1
Hospital General de Castellón
Castellon, Castellón, Spain, 12004
2
Hospital del Henares
Coslada, Madrid, Spain, 28822
3
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Madrid, Spain, 28702
4
Hospital Universitario Santa Lucía
Cartagena, Murcia, Spain, 30202