Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442299
Status:
SUSPENDED
Last Update Posted:
2007-03-01
First Post:
2007-02-28
Brief Title:
Albumin Dialysis in End-Stage Renal Disease Detoxification Capacity and Impact on Vascular Endothelial Function
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Phase 1 Study of Albumin Dialysis Using Prometheus in End Stage Renal Disease Detoxification Capacity and Impact on Vascular Endothelial Function
Status:
SUSPENDED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Major side-effects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The uremic syndrome is mainly related to the retention of a host of compounds due to altered glomerular filtration and other factors of renal dysfunction eg tubular secretion Uremic retention solutes are arbitrarily subdivided in three different categories according to their physicochemical characteristics and their subsequent behaviour during dialysis i the small water-soluble non-protein bound compounds ii the larger middle molecules mainly peptides and iii the small protein-bound compounds 1
Although direct proof is lacking several lines of evidence indicate that albumin is the most important carrier protein Removal of protein bound uremic retention solutes is limited
The Prometheus system fractionates blood into plasma and cellular components using an albumin-permeable polysulfon filter AlbuFlow with a specially designed sieving coefficient curve 10 for 2-microglobulin 06 for albumin 03 for IgG 01 for fibrinogen and 001 for IgM Due to the high sieving coefficient of the filter for large molecules ie cut-off at about 250 kD molecules up to the size of albumin 69 kD easily pass from blood into the secondary circuit which is filled with isotonic sodium chloride solution whereas larger molecules like fibrinogen 340 kD cannot pass through the filter In the secondary circuit the filtered plasma with the albumin-bound toxins flows through one or two adsorbers in a row with maximized adsorption capacity for putative liver toxins that are directly adsorbed fractionated plasma separation and adsorption or FPSA The purified plasma is then returned to the blood side of the albumin filter In order to eliminate water-soluble toxins blood thereafter undergoes hemodialysis using a conventional high-flux dialyser
We hypothesise that removal of protein bound uremic retention solutes can be improved by FPSA as compared to standard hemodialysis
Although direct proof is lacking several lines of evidence indicate that albumin is the most important carrier protein Removal of protein bound uremic retention solutes is limited
The Prometheus system fractionates blood into plasma and cellular components using an albumin-permeable polysulfon filter AlbuFlow with a specially designed sieving coefficient curve 10 for 2-microglobulin 06 for albumin 03 for IgG 01 for fibrinogen and 001 for IgM Due to the high sieving coefficient of the filter for large molecules ie cut-off at about 250 kD molecules up to the size of albumin 69 kD easily pass from blood into the secondary circuit which is filled with isotonic sodium chloride solution whereas larger molecules like fibrinogen 340 kD cannot pass through the filter In the secondary circuit the filtered plasma with the albumin-bound toxins flows through one or two adsorbers in a row with maximized adsorption capacity for putative liver toxins that are directly adsorbed fractionated plasma separation and adsorption or FPSA The purified plasma is then returned to the blood side of the albumin filter In order to eliminate water-soluble toxins blood thereafter undergoes hemodialysis using a conventional high-flux dialyser
We hypothesise that removal of protein bound uremic retention solutes can be improved by FPSA as compared to standard hemodialysis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None