Effect of HCO1100 on Cardiovascular Function (HicoCARD)

Vantive Health LLC

Status: Terminated

Conditions: Chronic Kidney Failure; Cardiovascular Disease

Treatments: Device: HCO 1100

Study type: Interventional

Funder types: Industry

Identifiers

NCT01363921

HicoCARD 1481

Details and patient eligibility

About

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

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Dialysis treatment with HCO1100

Experimental group

Treatment:

Device: HCO 1100