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Effect of HCO1100 on Cardiovascular Function (HicoCARD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01363921
Recruitment Status : Terminated (insufficient patient recruiting)
First Posted : June 2, 2011
Last Update Posted : April 5, 2017
Sponsor:
Collaborator:
Gambro Dialysatoren GmbH
Information provided by (Responsible Party):
Baxter Healthcare Corporation

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Chronic Kidney Failure Device: HCO 1100 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of High Cut-off Membranes on Cardiovascular Function in Patients With End-stage Renal Disease (HICOCARD)
Study Start Date : April 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure

Arm Intervention/treatment
Experimental: Dialysis treatment with HCO1100 Device: HCO 1100
Dialysis treatment with HCO1100
Other Name: High cut-off membrane




Primary Outcome Measures :
  1. Changes in hyperoxic chemoreflex sensitivity (CHRS) and flow mediated endothelial vasodilatation (FMD) [ Time Frame: max 15 weeks ]
    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 :
  1. Weekly assessment of albumin plasma levels (g/l) [ Time Frame: max 15 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363921


Locations
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Germany
Med. Klinik II, Nephrologie und med. Immunologie, Universitätsklinikum Aachen
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
Baxter Healthcare Corporation
Gambro Dialysatoren GmbH
Investigators
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Principal Investigator: Juergen Floege, MD Med.Klinik II, Universitätsklinikum Aachen
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Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01363921    
Other Study ID Numbers: HicoCARD 1481
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Keywords provided by Baxter Healthcare Corporation:
CKD5
dialysis
high porous membranes
micro-inflammation
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic