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Effect of HCO1100 on Cardiovascular Function (HicoCARD)

Primary Purpose

Cardiovascular Disease, Chronic Kidney Failure

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
HCO 1100
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Disease focused on measuring CKD5, dialysis, high porous membranes, micro-inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dialysis treatment with HCO1100

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 26, 2011
Last Updated
April 4, 2017
Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Dialysatoren GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01363921
Brief Title
Effect of HCO1100 on Cardiovascular Function
Acronym
HicoCARD
Official Title
Effect of High Cut-off Membranes on Cardiovascular Function in Patients With End-stage Renal Disease (HICOCARD)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
insufficient patient recruiting
Study Start Date
April 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Dialysatoren GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Chronic Kidney Failure
Keywords
CKD5, dialysis, high porous membranes, micro-inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dialysis treatment with HCO1100
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
HCO 1100
Other Intervention Name(s)
High cut-off membrane
Intervention Description
Dialysis treatment with HCO1100
Primary Outcome Measure Information:
Title
Changes in hyperoxic chemoreflex sensitivity (CHRS) and flow mediated endothelial vasodilatation (FMD)
Description
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.
Time Frame
max 15 weeks
Secondary Outcome Measure Information:
Title
Weekly assessment of albumin plasma levels (g/l)
Description
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.
Time Frame
max 15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juergen Floege, MD
Organizational Affiliation
Med.Klinik II, Universitätsklinikum Aachen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Med. Klinik II, Nephrologie und med. Immunologie, Universitätsklinikum Aachen
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Effect of HCO1100 on Cardiovascular Function

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