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NCT Number: NCT05099185

Water Soluble Vitamins and Trace Elements Loss in Hemodiafiltration Patients

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.

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Key information

Conditions

Chronic Hemolysis

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water-soluble vitamins and trace elements measures

Biological

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.

Primary outcomes

  1. 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).

    Time frame: Day 1

    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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: VITAFLUX

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 29, 2021
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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