Water Soluble Vitamins and Trace Elements Loss in Hemodiafiltration Patients (VITAFLUX)

Measurement of Water-soluble Vitamins and Trace Elements Loss With Maintenance Post-dilution Haemodiafiltration Patient

End stage renal disease is a severe pathology in which some toxic waste and an excessive amount of water can accumulate in the human body with life threatening consequences. Maintenance hemodialysis is one of the possible treatment for this disease.

Hemodialysis filter the blood through a membrane according to a dialysis bath and so can be able to purify the blood of the toxic waste.

Otherwise, since the 1980s, the investigator know that patient in maintenance hemodialysis can have some deficiency in water soluble vitamins and trace elements. Mechanisms of the deficiency are multiple (a decreased of food intake, a diminution of the appetite, digestive malabsorption du to medics and comorbidities and loss in hemodialysis).

Impact of this deficiency have an important impact on vital prognosis for these patients. These nutrients are essential for AND synthesis, mechanism of inflammation, cells membranes synthesis, etc. DOPPs study in 2004 have shown a decreased of 16% in the mortality within 4 years with supplemented patients. Also, since this study, international recommendations were wrote in 2009, then in 2020, in order to supplement in vitamins and trace elements patients in maintenance conventional hemodialysis.

Despite these recommendations, some supplementary efforts are necessary, especially since online hemodiafiltration, a new process, is widely available and used in particular in Europe. This process combines 2 phenomena, diffusion and convection, through high-flux membranes. This process can remove a large quantity of molecule present in blood and especially the middle-molecule. In return, a more important quantity of water soluble vitamins and oligo-elements could be removed by this technique.

Also, the investigator would like to measure this loss of vitamins and trace-elements in patients with maintenance online post-dilution hemodiafiltration process with dialysate sample and blood concentrations measured (usual patient monitoring) during the session.

Study Overview

• Status: Completed
• Conditions: Chronic Hemolysis
• Intervention / Treatment: Biological: Water-soluble vitamins and trace elements measures

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• France
  • Pierre-Bénite, France, 69310
    • Centre Hospitalier Lyon Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Maintenance hemodialysis patients who are treated in nephrology unit at Centre Hospitalier de Lyon Sud with online hemodiafiltration process

Description

Inclusion Criteria:

• Maintenance hemodialysis more than 3 months
• 3 sessions per week during 4 hours
• Hemodiafiltration process used with this patient on Lyon Sud Hospital
• Flow of the vascular access > 300 mL/min at least
• Age > 18 years
• Patient able to understand the study's goal

Exclusion Criteria:

• Active infectious or inflammatory disease
• Active malignant disease
• Intestinal malabsorptive disease
• Polysulfone's dialysis membrane allergy
• Patient under guardianship and judicial protection
• Pregnant and breastfeeding woman
• Opposition to the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Maintenance online post-dilution hemodiafiltration patients; Maintenance hemodialysis patients who undergo hemodialysis 3 times per week with online post-dilution hemodiafiltration process

Biological: Water-soluble vitamins and trace elements measures; We would like to measure water-soluble vitamins (B1, B6, B9, B12, C) and trace elements (zinc, selenium) in blood and dialysate for the patients treated by online post-dilution hemodiafiltration patients. There measures on blood are done systematically during the half-yearly report of our patients in our hemodialysis center. Only results are collect for the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the blood concentrations measured in vitamins and trace elements before and after the hemodialysis session by the post-dilution HDF technique during the half-yearly assessment (usual patient follow-up).	We would like to measure the concentrations of water-soluble vitamins and trace elements in dialysate by collecting 1% of this by Theraflux® device, and compare to the blood concentration collecting during the half-yearly report at the beginning then at the end of one hemodialysis session with online post-dilution hemodiafiltration session.	Day 1

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Etienne NOVEL-CATIN, MD, Nephrology department

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2021
• Primary Completion (Actual): December 10, 2021
• Study Completion (Actual): December 10, 2021

Study Registration Dates

• First Submitted: July 16, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemolysis; Physiological Effects of Drugs; Micronutrients; Trace Elements
• Other Study ID Numbers: 69HCL21_0491; 2021-A01241-40 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No