Reduction Ratio and Clearance During Hemodialysis With MCO-filter Compared to HDF With Standard High-flux Filter

Dialysis Clinical Trial

Official title:

Reduction Ratio and Clearance of Middle Molecules During a Single Hemodialysis Session With Medium Cut-Off (MCO) Filter Compared to Hemodiafiltration (HDF) With Standard High-flux Filter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03437538
• Other study ID #: 2017/830/1
• Status: Completed
• Phase: N/A
• Start date: May 21, 2018
• Est. completion date: April 16, 2019

Study information

• Verified date: November 2019
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Medium Cut-Off dialysis (MCO) membrane has been developed to improve middle molecule removal compared to standard high-flux dialysis filters.

The major aim of this study is to compare the reduction ratio of middle molecules, during a single hemodialysis session with MCO-filter, compared to hemodiafiltration (HDF) with standard high-flux filter.

Secondary aims are to compare the reduction ratio of small and large molecules between the treatments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 16, 2019
• Est. primary completion date: April 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ongoing HDF treatment

• CRP <30

• No Acute Myocardial Infarction within 3 months.

Exclusion Criteria:

• Not able to understand the study information.

Related Conditions & MeSH terms

• Chronic Kidney Failure
• Dialysis
• Kidney Failure, Chronic
• Renal Insufficiency
• Uremia

Intervention

Device:
• MCO-HD
Measurements will be done during a single hemodialysis session with Medium Cut-Off filter
• High-flux HDF
Measurements will be done during a single hemodiafiltration session with standard high-flux filter

Locations

Country	Name	City	State
Sweden	Skane University Hospital	Malmö

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction ratio (RR) of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)	Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100%	4 hours
Primary	Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)	Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.	30 minutes
Primary	Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)	Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.	60 minutes
Primary	Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)	Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.	120 minutes
Primary	Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)	Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.	240 minutes
Secondary	RR of large molecules (Albumin, Transferrin, IgG)	Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100%	4 hours
Secondary	RR of small molecules (Urea, Phosphate, Creatinine)	Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100%	4 hours
Secondary	Number of Adverse Events	Number of adverse events during a 4h dialysis session	4 hours
Secondary	Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)	Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.	30 minutes
Secondary	Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)	Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.	60 minutes
Secondary	Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)	Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.	120 minutes
Secondary	Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)	Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.	240 minutes
Secondary	Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)	Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.	30 minutes
Secondary	Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)	Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.	60 minutes
Secondary	Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)	Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.	120 minutes
Secondary	Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)	Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.	240 minutes