Clinical trial NCT01363921: Effect of HCO1100 on Cardiovascular Function
Official title: Effect of High Cut-off Membranes on Cardiovascular Function in Patients With End-stage Renal Disease (HICOCARD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiovascular Disease
Chronic Kidney Failure
Keywords: CKD5
dialysis
high porous membranes
micro-inflammation
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Gambro Dialysatoren GmbH
name: Baxter Healthcare Corporation
First posted: 2011-06-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in hyperoxic chemoreflex sensitivity (CHRS) and flow mediated endothelial vasodilatation (FMD)
timeFrame: max 15 weeks
Secondary outcomes:
measure: Weekly assessment of albumin plasma levels (g/l)
timeFrame: max 15 weeks
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Med. Klinik II, Nephrologie und med. Immunologie, Universitätsklinikum Aachen
state: NRW
Study officials:
affiliation: Med.Klinik II, Universitätsklinikum Aachen
name: Juergen Floege, MD
role: PRINCIPAL_INVESTIGATOR
References: