Effect of Hemodiafiltration Plus MCOs on Uremic Toxins Removal

NCT03938285 | Unknown

• 1 other identifier: PT-19-103
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Uremic Toxins Clearance

  The combination of On Line Hemodiafiltration with an MCO membrane will have a better sieving coefficient for middle and protein bound molecules in comparison with other dialysis modalities.

  1 month

Study Arms (4)

High Flux Hemodialysis

ACTIVE COMPARATOR

High Flux Hemodialysis with an FxCordiax 120 membrane, with Qb of 350, 4 hours of treatment.

Other: FxCordiax 120 membrane

Extended Hemodialysis

ACTIVE COMPARATOR

Extended Hemodialysis with a Theranova 400 membrane, with Qb of 350, 4 hours of treatment.

Other: Theranova 400 membrane

On Line Hemodiafiltration

ACTIVE COMPARATOR

On Line Hemodiafiltration with an FxCordiax 120 membrane, with Qb of 350, 4 hours of treatment, and post filter substitution rate of 20-21 liters.

Other: FxCordiax 120 membrane

On Line Hemodiafiltration with an MCO membrane

ACTIVE COMPARATOR

On Line Hemodiafiltration with a Theranova 400 membrane, with Qb of 350, 4 hours of treatment, and post filter substitution rate of 20-21 liters.

Other: Theranova 400 membrane

Interventions

Theranova 400 membrane OTHER

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.

Extended Hemodialysis; On Line Hemodiafiltration with an MCO membrane

FxCordiax 120 membrane OTHER

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.

High Flux Hemodialysis; On Line Hemodiafiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater or equal to 18 years.
• Patients that receive OL-HDF three times per week.
• Patients with no residual uresis.
• Hemoglobin greater that 7 g/L.
• Patients that can exercise during treatment.
• Patients must sign informed consent.

You may not qualify if:

• Age less tan 18.
• Presence of residual uresis.
• Hb less that 7 g/L.
• Patients incapable of exercising during dialysis.

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez: lead
• Renal Research Institute: collaborator

Study Sites (2)

Instituto Nacional de Cardiologia Ignacio Chávez

Mexico City, 14080, Mexico

Location

Instituto Nacional de Cardiología Ignacio Chávez

México, 14080, Mexico

Location

Related Publications (1)

• Armenta-Alvarez A, Lopez-Gil S, Osuna I, Grobe N, Tao X, Ferreira Dias G, Wang X, Chao J, Raimann JG, Thijssen S, Perez-Grovas H, Canaud B, Kotanko P, Madero M. Removal of Middle Molecules and Dialytic Albumin Loss: A Cross-over Study of Medium Cutoff and High-Flux Membranes with Hemodialysis and Hemodiafiltration. Kidney360. 2023 Aug 1;4(8):1095-1102. doi: 10.34067/KID.0000000000000185. Epub 2023 Jun 12.

  PMID: 37651666 DERIVED

Study Officials

• Magdalena Madero, MD

  Instituto Nacional de Cardiologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Nephrology

Model Details: 12 patients will be included, they will be divided in 4 groups: high flux HD, extended HD (HDx), OL-HDF, and OL-HDF with medium cut-off membrane. All sessions will be performed in a 5008S CorDiax that enables HD and OL-HDF, we will use an FX CorDiax 80 dializer (effective area 1.8 m2) for OL-HDF and conventional HD, and the Theranova 400 dializer (effective area 1.7 m2)for OL-HDF with medium cut-off membrane, and HDx. Every patient will be in each of the 4 groups, and they will receive 3 sessions in each group. Every session will have a duration of 240 minutes with a Qb of 300 mL/min. Blood samples will be drawn in every session, every blood sample will consist of 4-6 mL of EDTA plasma; this volumen would include 0.5 mL for biobanking, blood will be drawn from the arterial, and venous outlet, and a dialysate sample will be drawn in every time point.

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 6, 2019
• Study Start: May 2, 2019
• Primary Completion: June 1, 2019
• Study Completion: August 1, 2020
• Last Updated: March 13, 2020

Record last verified: 2020-03

Locations

ME (2)