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Comparison the effect of HDx therapy and high flux hemodialysis on endothelium function in hemodialysis patients

A randomized, open-label, crossover, clinical trial to compare the effect of HDx therapy versus high flux hemodialysis on endothelium function in hemodialysis patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2m67zd
Enrollment
Unknown
Registered
2018-06-28
Start date
2018-07-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

Interventions

Hemodialysis with high-performance membrane (Theranova) will be performed on 32 patients with chronic kidney disease 3 times a week for 12 weeks. Endothelial function will be evaluated by brachial art
Procedure/surgery

Sponsors

Fundação Oswaldo Ramos - Hrim
Lead Sponsor
Fundação Oswaldo Ramos - Hrim
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Male and female aged 18 years old;in hemodialysis program for at least 6 months before the enrollment; with adequate vascular access; hemodialysis 4 hours 3 times/week; with a result of KtV 1.2 in the 3 months prior to the study and signed the ICF.

Exclusion criteria

Exclusion criteria: Patients with Heart failure III or IV NY class; peripheral arterial disease, previous stroke within the last 3 months before the enrollment; active inflammation or infection disease within the last 3 months before the enrollment; pregnant or lactating female.

Design outcomes

Primary

MeasureTime frame
The expected outcome will be an improvement of endothelial function, defined as an increase of the percentage of flow-mediated dilation evaluated in the brachial artery ultrasound at the end of each phase of the study

Secondary

MeasureTime frame
The expected outcome will be an acute improvement of endothelial function, defined by an increase of the percentage of flow-mediated dilatation assessed by the endopat at the end of the first dialysis session in each phase of the study

Countries

Brazil

Contacts

Public ContactSilvia Manfred

Fundação Oswaldo Ramos - Hrim

silvia.hemod@hrim.com.br+55-011-59048499

Outcome results

None listed

Source: REBEC (via WHO ICTRP)