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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Inflammation
Time Frame: 3 months
Value of IL-6
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ospedale Santa Maria Annunziata

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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