Status:
UNKNOWN
Efficacy of Uremic Toxins Clearance With Expanded Hemodialysis
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborating Sponsors:
Baxter México
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to quantify the B2-microglobulin reduction rate based on the type of extracorporeal therapy (ET) used: HDx (expanded hemodialysis), HDc (high-flux conventional hemodialysis), ...
Detailed Description
A controlled, randomized, crossover clinical trial is planned to compare the magnitude of the B2-microglobulin reduction rate in three different extracorporeal therapies (ETs): HDc, HDx, and HDF. The...
Eligibility Criteria
Inclusion
- Over 18 years
- Anuric patients (residual urinary volume ≤ 100 mL/24 h)
- Intermittent chronic hemodialysis (three sessions per week, of 3.5 to 4 hours each)
- Without modification of their prescription in the last three months
- Functional arteriovenous fistula, indwelling vascular access (Qb ≥ 300 mL/min), or both
- Letter of acceptance to enter the protocol and a signed informed consent.
Exclusion
- Under 18 years
- Active intake or intake in the last six months of immunosuppressants or systemic steroids
- Active autoimmune disease
- Evidence of active systemic infectious event at the time of inclusion or two weeks prior
- Diagnosis of neoplasia or active oncological disease
- Hypoalbuminemia (\< 3.2 g/dL)
- Pregnancy or lactation
- Refusal to participate in the study
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04786535
Start Date
May 10 2021
End Date
January 1 2022
Last Update
September 17 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico, 14080