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Effect of Hemodiafiltration Plus MCOs on Uremic Toxins Removal

NCT03938285 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-03-13

No results posted yet for this study

Summary

Conventional hemodialysis is essential for the treatment of ESRD patients by reducing serum concentration of uremic toxins and correcting fluid overload. Nevertheless, HD removes almost exclusively low-range uremic toxins. Convective methods might reduce complications associated to molecules of medium-range molecular weight. On-Line Hemodiafiltration (OL-HDF) is the result of the combination between convection and diffusion, this modality allows better clearence of middle-range molecules, and protein bound molecules with better hemodynamic tolerance, but at higher cost. In order to solve this problem the middle cut-off membranes were developed, achieving cleareance of molecules between 15,000 to 40,000 Da with low albumin loss. To our knowledge no study has ever evaluated the use of middle cut-off membranes on OL-HDF. This is a prospective, experimental study which will include 12 patients with ESRD that receive OL-HDF treatment on the National Institute of Cardiology "Ignacio Chavez" OL-HDF Unit. They will be divided in 4 groups: high flux HD, extended HD (HDx), OL-HDF, and OL-HDF with medium cut-off membrane.

Conditions

  • Hemodiafiltration
  • Chronic Kidney Disease Requiring Chronic Dialysis

Interventions

OTHER

Theranova 400 membrane

Patients will receive 4 different dialysis treatment, HD with a high flux membrane, extended HD, On Line Hemodiafiltration, and the novel On Line Hemodiafiltration with an MCO membrane.

OTHER

FxCordiax 120 membrane

Patients will receive 4 different dialysis treatment, HD with a high flux membrane, extended HD, On Line Hemodiafiltration, and the novel On Line Hemodiafiltration with an MCO membrane.

Sponsors & Collaborators

  • Renal Research Institute

    collaborator OTHER

  • Instituto Nacional de Cardiologia Ignacio Chavez

    lead OTHER

Principal Investigators

  • Magdalena Madero, MD · Instituto Nacional de Cardiologia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-02
Primary Completion
2019-06-01
Completion
2020-08-01

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03938285 on ClinicalTrials.gov