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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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9 January 2023 |
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Main ID: |
NCT01445366 |
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Date of registration:
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22/09/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Solute Removal With High Volume Hemodiafiltration Versus Long High Flux Hemodialysis
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Scientific title:
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Solute Removal With High Volume Hemodiafiltration Versus Long High Flux Hemodialysis |
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Date of first enrolment:
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April 2012 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01445366 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Raymond Vanholder, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Ghent |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Chronic kidney disease (CKD) stage 5 with hemodialysis or hemodiafiltration treatment
for more than three months.
- No vascular access related problems (Arteriovenous (A/V) fistula, graft or bi-flow
catheter)
- Double needle/lumen vascular access
- No ongoing infection
- Singed informed consent form
Exclusion Criteria:
- Inclusion criteria not met
- Known HIV or active hepatitis B or C infection (Positive Polymerisation Chain Reaction
(PCR))
- Pregnancy
- Unstable clinical condition (e.g. cardiac or vascular instability)
- Known coagulation problems
- Patients participating in another study interfering with the planned study.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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End-stage Renal Disease
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Intervention(s)
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Device: High volume post dilution hemodiafiltration
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Device: high flux hemodialysis
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Primary Outcome(s)
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Uremic retention solute concentrations from pre and post dialysis blood samples,dialyzer inlet and outlet blood samples,and spent dialysate samples.
[Time Frame: During 4 hours]
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Uremic retention solute concentrations from pre and post dialysis blood samples,dialyzer inlet and outlet blood samples,and spent dialysate samples.
[Time Frame: During 8 hours]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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