Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442819
Status:
COMPLETED
Last Update Posted:
2007-03-02
First Post:
2007-03-01
Brief Title:
Uremic Pruritus Cytokines and Polymethylmethacrylate Artificial Kidney
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Uremic pruritus is one of the common complications in long-term dialysis patients In general many factors including xerosis elevated serum calcium phosphate calcium-phosphate product hyperparathyroidism and inadequate dialysis may contribute to it Recently researchers reported that immuno-hypothesis with high serum level of cytokines could be the cause of uremic pruritus Polymethylmethacrylate PMMA artificial kidney AK has been reported to adsorb more serum cytokines than other high flux artificial kidneys
Methods In July 2006 30 patients with severe uremic pruritus from 300 chronic hemodialysis patients in a single center entered this prospective study Their dialyzers were changed to PMMA AK for 4 weeks The severity of pruritus was evaluated every week using the results of a questionnaire pruritus score Laboratory assays including pre-dialysis serum blood urea nitrogen creatinine β2-microgblubulin β2M calcium phosphate intact parathyroid hormone iPTH total CO2 ferritin hematocrit high sensitivity C-reactive protein hsCRP IL-1 IL-2 IL-6 IL-18 TNF-α KTV and β2M clearance were measured before and at the end of 4 weeks of PMMA AK use
Expected ResultsTo prove the PMMA membrane could improve the uremic pruritus and to reveal the effect of PMMA membrane on serum level of possible factors contributing to uremic pruritus
Methods In July 2006 30 patients with severe uremic pruritus from 300 chronic hemodialysis patients in a single center entered this prospective study Their dialyzers were changed to PMMA AK for 4 weeks The severity of pruritus was evaluated every week using the results of a questionnaire pruritus score Laboratory assays including pre-dialysis serum blood urea nitrogen creatinine β2-microgblubulin β2M calcium phosphate intact parathyroid hormone iPTH total CO2 ferritin hematocrit high sensitivity C-reactive protein hsCRP IL-1 IL-2 IL-6 IL-18 TNF-α KTV and β2M clearance were measured before and at the end of 4 weeks of PMMA AK use
Expected ResultsTo prove the PMMA membrane could improve the uremic pruritus and to reveal the effect of PMMA membrane on serum level of possible factors contributing to uremic pruritus
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