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
NCT number | NCT03437538 |
Other study ID # | 2017/830/1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 21, 2018 |
Est. completion date | April 16, 2019 |
Verified date | November 2019 |
Source | Region Skane |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Skane University Hospital | Malmö |
Lead Sponsor | Collaborator |
---|---|
Region Skane | Lund University |
Sweden,
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 |
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