Hemo Filtration Reinfusion (HFR) Clearance Efficiency Towards P-bound Toxins and Effects on Inflammatory and Endothelial Damage Markers

• Register: ClinicalTrials.gov
• Last refreshed on: 7 April 2015
• Main ID: NCT02240004
• Date of registration: 10/09/2014
• Prospective Registration: No
• Primary sponsor: Hospital Universitario Reina Sofia
• Public title: Hemo Filtration Reinfusion (HFR) Clearance Efficiency Towards P-bound Toxins and Effects on Inflammatory and Endothelial Damage Markers SUPREMO
• Scientific title: Removal of Uremic Toxins and Improvement of Chronic Inflammation With HFR in Comparison With "On-Line" Hemodiafiltration and High Flux Hemodialysis.
• Date of first enrolment: May 2014
• Target sample size: 9
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02240004
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Cross-Sectional
• Phase: N/A

Countries of recruitment

Spain

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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)

Exclusion Criteria:

- active neoplasia

- positive viral markers (HBsAg, anti-HCV and HIV),

- clinical signs of active infection and/or inflammation,

- albumin < 3.5 g/dl.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Inflammation

Intervention(s)

Device: SUPRA HFR

Primary Outcome(s)

Inflammatory status: (CD14+ CD16+, CD14++ CD16+, cytokines levels) [Time Frame: 12 weeks]

Secondary ID(s)

CRB2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors