Effect of HCO1100 on Cardiovascular Function

Study Overview
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Brief Summary
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The purpose of this study is to determine whether high porous membranes are effective in the treatment of cardiovascular events in chronic dialysis patients.

Detailed Description
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Cardiovascular events are the leading cause of the increased mortality rate of chronic dialysis patients. It is believed that increased micro-inflammation plays an important role in the pathophysiological process of cardiovascular disease. High porous dialysis membranes can better eliminate inflammatory mediators as compared to standard dialysis membranes. In this study, the high porous dialysis membrane HCO1100 is investigated for its potential capability to improve the cardiovascular status of chronic dialysis patients.

Official Title
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Effect of High Cut-off Membranes on Cardiovascular Function in Patients With End-stage Renal Disease (HICOCARD)

Conditions
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Cardiovascular Disease, Chronic Kidney Failure

Intervention / Treatment
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* Device: HCO 1100


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Dialysis dependent chronic renal failure (CKD 5) in a stable condition Serum albumin at randomisation equal to or above the median of the normal range (pre- dialysis value) Exclusion Criteria: Diabetes mellitus as the disease underlined end stage renal failure Haemodynamic instability that precludes unsupported dialysis planned surgical interventions <= 4 months at time of inclusion known allergy against dialysis membranes Significant cardiac disease (atrial fibrillation, myocardial infarction within 6 months; unstable angina pectoris; LV-EF < 30%, clinically significant pericardial disease; cardiac amyloidosis) pulmonary disease with chronic hypoxia Advanced disease or significant co-morbidity with poor short term prognosis, necessitating palliation and not subject to active or disease specific treatment Clinically significant liver dysfunction (bilirubin > 1.8mg/dl (30µmol/L)) Prior fistula surgery on both arms or other operations or paralysis on both arms Known HIV, HCV infection Alcoholism Active uncontrolled infection Pregnancy or lactation Inability to give informed consent to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dialysis treatment with HCO1100<br> | Device: HCO 1100<br>* Dialysis treatment with HCO1100<br>* Other names: High cut-off membrane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in hyperoxic chemoreflex sensitivity (CHRS) and flow mediated endothelial vasodilatation (FMD) | Changes of CHRS (ms/mmHg) and FMD (%) between pre- and post- treatment phase with study product HCO1100 dialyzer and at 6 weeks follow up after termination of HCO1100 dialyzer treatment phase will be assessed. | max 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly assessment of albumin plasma levels (g/l) | Weekly evaluation of albumin plasma levels (g/l) during the study. Patients with albumin plasma levels below 35g/l will terminate study product (HCO1100 dialyzer) treatment phase and switch to study phase with control standard dialyzer treatment and will be further monitored for 6 weeks. Number of patients with decreased albumin levels below 35g/l , Number of patients with requirement for albumin substitution and absolute albumin drop (g/l) will be evaluated. | max 15 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD5, dialysis, high porous membranes, micro-inflammation