Effect of HCO1100 on Cardiovascular Function

Cardiovascular Disease Clinical Trial

— HicoCARD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01363921
• Other study ID #: HicoCARD 1481
• Status: Terminated
• Phase: N/A
• First received: May 26, 2011
• Last updated: April 4, 2017
• Start date: April 2011
• Est. completion date: September 2013

Study information

• Verified date: April 2017
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Chronic Kidney Failure
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Device:
• HCO 1100
Dialysis treatment with HCO1100

Locations

Country	Name	City	State
Germany	Med. Klinik II, Nephrologie und med. Immunologie, Universitätsklinikum Aachen	Aachen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Gambro Dialysatoren GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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