Effects of Postdilution Online Hemodiafiltration With AcEtate-free Citrate dialySis Fluid on Inflammation Markers (HEPHAESTUS)

December 16, 2020 updated by: Francesco Pizzarelli, Ospedale Santa Maria Annunziata

tHe Effects of Postdilution Online Hemodiafiltration With AcEtate-free Citrate dialySis Fluid on Inflammation Markers in TUscan Prevalent Hemodialysis patientS: HEPHAESTUS Study

The aim of this study was to evaluate the effect and timing of action on the inflammatory state of a acetate-free containing citrate concentrate (Cit-, 1 mM Citrate) in online postidultion HDF with high volumes compared to traditional concentrated (Ac-, 3 mM of acetate ) in the medium term. In addition, the study will evaluate other parameters of efficiency dialysis, cardiovascular stability, the safety of the concentrate with regard to bone metabolism and vessel calcification in the medium term.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study was to evaluate if a hemodiafiltration with concentrated citrate (Cit-HDF) in 3 months can reduce the inflammation markers, evaluated by a Predialytic value of Beta2-microglobulin (B2m), CRP and IL6 compared to traditional concentrated acetic acid (Ac-HDF).

The secondary objectives of this study are to evaluate if Cit-HDF, compared to Ac-HDF, can have an effect in a period of 3 months on the following aspects:

  • the change weekly pre-dialysis values of other markers of oxidative stress (TAC, NF-kB);
  • the technical parameters of HDF treatment, such as convective volumes, and blood pressure in the circuit in the filter (TMP, pressure pre-filter);
  • the cardiovascular stability through blood pressure and heart rate before and after dialysis (SBP, DBP, HR) and number of intradialytic hypotension;
  • the parameters of safety as the variation of the values of the mobility Predialytic bone (PTH, alkaline phosphatase, fetuin-A), the variation of the values intradialytic biochemical impacted by citrate (total and ionized calcium, bicarbonate) and clotting time (aPTT);

  • the variation of calcifications observed by:

    • the expression of molecules that express the ability of calcification of muscle cells and endothelial cells in culture with plasma taken at the beginning of treatment
    • a measure of carotid intimal thickness and pulse vawe velocity by Eco Color Doppler (optional);
  • dialysis efficiency by varying pre-and post-dialysis (RR%) and Clearance average molecular weight solutes with small and medium (Phosphorus, Beta2 Micro, Myoglobin) and indices of dialysis adequacy of small molecules such as EKT / V based on the dialysance ion formula Watson (calculated automatically by the monitor to dialysis);

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Lucca, Italy
        • Ospedale Campo di Marte
    • Fi
      • Firenze, Fi, Italy
        • OSpedale Santa Maria Annunziata
    • Lucca
      • Lido Di Camaiore, Lucca, Italy
        • Ospedale Versilia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • Patients clinically stable.
  • age> 18.
  • HDF in renal replacement therapy for more than 1 month.
  • good functionality of the vascular blood flow that allows real at least 250 ml / min. and recirculation below 10%.

Description

Inclusion Criteria:

. Patients clinically stable.

  • age> 18.
  • HDF in renal replacement therapy for more than 1 month.
  • good functionality of the vascular blood flow that allows real at least 250 ml / min. and recirculation below 10%.

Exclusion Criteria:

  • Life expectancy <3 months.
  • With residual renal function> 500 ml / day.
  • Vascular access with CVC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Concentrate SelectBag One
Each patient will be subjected to two stages of each month, where it will be treated with online HDF postdilution: first of all concentrate SelectBag One (with 3 mM of acetic acid and 0 mM of citrate)
Device: SelectBag One
Each patient will be subjected to two stages of each month, where it will be treated with online HDF postdilution with two kind of concentrates: acetic acid (Ac-HDF) and acetate-free citrate containing one (HDF-Cit ). For each of the sessions will be used online HDF postdilution with TMP biofeedback (UltraControl) and Filter high permeability.
Other Names:
  • SelectBag Citrate
Concentrate SelectBag Citrate
Each patient will be subjected to two stages of each month, where it will be treated with online HDF postdilution, then with SelectBag Citrate (with 0 mM of acetic acid and 1 mM of citric acid)
Device: SelectBag One
Each patient will be subjected to two stages of each month, where it will be treated with online HDF postdilution with two kind of concentrates: acetic acid (Ac-HDF) and acetate-free citrate containing one (HDF-Cit ). For each of the sessions will be used online HDF postdilution with TMP biofeedback (UltraControl) and Filter high permeability.
Other Names:
  • SelectBag Citrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammation
Time Frame: 3 months
Value of IL-6
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dialytic dose
Time Frame: 3 months
convective exchange volumes
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Santa Maria Annunziata

Investigators

  • Principal Investigator: Francesco Pizzarelli, Dr, Ospedale Santa Maria Annunziata_ Firenze (Italy)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2016

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 5, 2016

First Posted (ESTIMATE)

August 11, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEPHAESTUS_020713

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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