Effect of HCO1100 on Cardiovascular Function

NCT ID: NCT01363921

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2013-09-30

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.

Conditions

Cardiovascular Disease; Chronic Kidney Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dialysis treatment with HCO1100

Group Type: EXPERIMENTAL

HCO 1100

Intervention Type: DEVICE

Dialysis treatment with HCO1100

Interventions

HCO 1100

Dialysis treatment with HCO1100

Intervention Type: DEVICE

Other Intervention Names

High cut-off membrane

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gambro Dialysatoren GmbH

INDUSTRY

Sponsor Role: collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Vantive Health LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juergen Floege, MD

Role: PRINCIPAL_INVESTIGATOR

Med.Klinik II, Universitätsklinikum Aachen

Locations

Med. Klinik II, Nephrologie und med. Immunologie, Universitätsklinikum Aachen

Aachen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

HicoCARD 1481

Identifier Type: -

Identifier Source: org_study_id