InflammationSUPREMONCT02240004
Hemo Filtration Reinfusion (HFR) Clearance Efficiency Towards P-bound Toxins and Effects on Inflammatory and Endothelial Damage Markers
An observational study of Inflammation, run by Hospital Universitario Reina Sofia de Cordoba at 1 site in Spain.
Trial summary
The aim of this study is to compare purification efficiency of HFR in terms of clearance of protein-bound toxins and the effects on markers of inflammation and endothelial damage, in comparison to HF-HD and OL-HDF. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- SUPRA HFR
- Type of treatment
- Medical device
- How many people
- 9 participants
- Where
- 1 siteSpain
- Study dates
- May 2014to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing dialysis three times week
Who may be able to join
- Stable patients on hemodialysis for al least 3 month
- older than 18 year old
- dialyzed at least for two months with a high-flux membrane permeability
- arteriovenous fistula with high blood flow (> 350 ml / min)
Who cannot join
- active neoplasia
- positive viral markers (HBsAg, anti-HCV and HIV),
- clinical signs of active infection and/or inflammation,
- albumin < 3.5 g/dl.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Removal of Uremic Toxins and Improvement of Chronic Inflammation With HFR in Comparison With "On-Line" Hemodiafiltration and High Flux Hemodialysis.
The aim of this study is to compare purification efficiency of HFR in terms of clearance of protein-bound toxins and the effects on markers of inflammation and endothelial damage, in comparison to HF-HD and OL-HDF.
Read the detailed description
Protein-bound uremic toxins are poorly removed by current dialysis techniques because of their size, which is larger than the pore size of dialysis membranes available in the market. These protein-bound uremic toxins have emerged as important risk factors for progression of CKD, as well as for cardiovascular disease. Several studies have demonstrated that protein-bound uremic toxins induce vascular inflammation, endothelial dysfunction and vascular calcification.
In dialysis patients, serum concentrations of p-cresyl sulphate and indoxyl sulphate are approximately 17 and 54 times higher, respectively, than in healthy subjects. Because these toxins are bound to proteins, only a 30% or less is removed efficiently by hemodialysis. Traditional renal replacement therapies depend upon diffusion and convection for solute clearances and the use of an adsorbent in combination with dialysis membranes may be a new therapeutic option to increase removal rate of these uremic protein-bound toxins.
HFR technique uses a dual dialyzer with a resin between chambers. The first chamber is a high-flux membrane where convective process takes place. The ultrafiltrate obtained from this first chamber passes through the cartridge and is reinfused before the second chamber, a low-flux membrane, where diffusive process is performed.
In HFR, adsorption and haemodiafiltration are attached, using ultrafiltrate as a replacement fluid and being capable of theoretically removing most medium and high molecular weight uremic toxins. A potential benefit has been regarded for toxicity, biocompatibility, tolerance, and preservation of essential elements such as albumin, vitamins, amino acids or growth factors. An improvement on oxidative stress has also been described in HFR.
- Conditions
- Inflammation
- Being tested
- SUPRA HFR
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUPRA HFRDevice
usual dialytic prescription for duration, frequency, acid buffer and anticoagulation regimen
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory status: (CD14+ CD16+, CD14++ CD16+, cytokines levels)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Reina Sofia de Cordoba
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alejandro Martin-Malo, Hospital Universitario Reina Sofia de Cordoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240004
- Sponsor's protocol ID
- CRB2014
- Acronym
- SUPREMO
- Status last verified
- Mar 2015
- First submitted
- 10 Sep 2014
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Removal of Uremic Toxins and Improvement of Chronic Inflammation With HFR in Comparison With "On-Line" Hemodiafiltration and High Flux Hemodialysis.
- ClinicalTrials.gov ID
- NCT02240004
- Acronym / sponsor ID
- SUPREMO / CRB2014
- Conditions
- Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Hospital Universitario Reina Sofia de CordobaOther government
- Study start
- May 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare purification efficiency of HFR in terms of clearance of protein-bound toxins and the effects on markers of inflammation and endothelial damage, in comparison to HF-HD and OL-HDF.
Detailed description
Protein-bound uremic toxins are poorly removed by current dialysis techniques because of their size, which is larger than the pore size of dialysis membranes available in the market. These protein-bound uremic toxins have emerged as important risk factors for progression of CKD, as well as for cardiovascular disease. Several studies have demonstrated that protein-bound uremic toxins induce vascular inflammation, endothelial dysfunction and vascular calcification.
In dialysis patients, serum concentrations of p-cresyl sulphate and indoxyl sulphate are approximately 17 and 54 times higher, respectively, than in healthy subjects. Because these toxins are bound to proteins, only a 30% or less is removed efficiently by hemodialysis. Traditional renal replacement therapies depend upon diffusion and convection for solute clearances and the use of an adsorbent in combination with dialysis membranes may be a new therapeutic option to increase removal rate of these uremic protein-bound toxins.
HFR technique uses a dual dialyzer with a resin between chambers. The first chamber is a high-flux membrane where convective process takes place. The ultrafiltrate obtained from this first chamber passes through the cartridge and is reinfused before the second chamber, a low-flux membrane, where diffusive process is performed.
In HFR, adsorption and haemodiafiltration are attached, using ultrafiltrate as a replacement fluid and being capable of theoretically removing most medium and high molecular weight uremic toxins. A potential benefit has been regarded for toxicity, biocompatibility, tolerance, and preservation of essential elements such as albumin, vitamins, amino acids or growth factors. An improvement on oxidative stress has also been described in HFR.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing dialysis three times week
Key inclusion criteria (4 listed)
- Stable patients on hemodialysis for al least 3 month
- older than 18 year old
- dialyzed at least for two months with a high-flux membrane permeability
- arteriovenous fistula with high blood flow (> 350 ml / min)
Key exclusion criteria (4 listed)
- active neoplasia
- positive viral markers (HBsAg, anti-HCV and HIV),
- clinical signs of active infection and/or inflammation,
- albumin < 3.5 g/dl.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUPRA HFRusual dialytic prescription for duration, frequency, acid buffer and anticoagulation regimen | Device | – |
Primary outcome
Inflammatory status: (CD14+ CD16+, CD14++ CD16+, cytokines levels)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
Related trials for Inflammation
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation, run by Hospital Universitario Reina Sofia de Cordoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory status: (CD14+ CD16+, CD14++ CD16+, cytokines levels) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2015.