Trials / Completed
CompletedNCT02964429
Determination In-vivo KUF for Diacap Pro Hemodialyser
Determination of the In-vivo Ultrafiltration Coefficient and Evaluation of Performance, Hemo- and Biocompatibility- and Safety-data of High Flux Hemodialyser Diacap Pro in Patients With End Stage Renal Disease on Chronic Hemodialysis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- B.Braun Avitum AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this study is the determination of the in-vivo ultrafiltration coefficient (in-vivo KUF) for Diacap Pro dialyzers following routine dialysis prescription in the United States.
Detailed description
The in-vivo KUF for Diacap Pro High Flux dialysers with the surface sizes of 1.3/ 1.6/ 1.9 sqm will be determined as required by the US guideline "Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers 1998" for comparison with the in-vitro KUF data. Clinical data of at least 12 patients will be collected for determination of the in-vivo KUF complemented by safety-, performance-data for the removal of small and middle molecular substances and hemocompatibility data.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Diacap Pro High-Flux | During dialysis treatment ultrafiltration rate will be changed following a fixed schedule and resulting changes in Transmembrane Pressure (TMP) recorded to generate data for calculation of the in-vivo KUF. |
Timeline
- Start date
- 2016-11-14
- Primary completion
- 2016-12-23
- Completion
- 2016-12-23
- First posted
- 2016-11-16
- Last updated
- 2017-02-07
Locations
1 site across 1 country: Czechia
Source: ClinicalTrials.gov record NCT02964429. Inclusion in this directory is not an endorsement.