Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574425
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-25
Brief Title:
Long-term High Blood Flow Hemoadsorption Therapy in Patients Undergoing Maintenance Hemodialysis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Prospective Cohort Study on the Safety and Efficacy of Long-term High Blood Flow Hemoadsorption Therapy in Patients Undergoing Maintenance Hemodialysis
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ObjectiveThe purpose of the study is to confirm that extending the duration of hemoadsorption HA and increasing blood flow during the HAhemodialysis HD treatment process is safe and feasible and to verify that extending the HP treatment duration can further increase the clearance of protein-bound uremic toxins
Methods The study employs a multicenter prospective cohort design with a self-controlled before-and-after comparison The duration of HAHD treatment for maintenance hemodialysis MHD patients is extended to 4 hours and the extracorporeal blood flow rate is increased to over 250-350 mlmin The safety of the treatment is assessed by evaluating the safety of the procedure the levels of relevant toxins in the patients blood are measured before and after treatment and the clearance rate of uremic toxins after a single treatment is calculated and compared with the self-controlled before-and-after data to determine whether the modified protocol can remove more uremic toxins
Methods The study employs a multicenter prospective cohort design with a self-controlled before-and-after comparison The duration of HAHD treatment for maintenance hemodialysis MHD patients is extended to 4 hours and the extracorporeal blood flow rate is increased to over 250-350 mlmin The safety of the treatment is assessed by evaluating the safety of the procedure the levels of relevant toxins in the patients blood are measured before and after treatment and the clearance rate of uremic toxins after a single treatment is calculated and compared with the self-controlled before-and-after data to determine whether the modified protocol can remove more uremic toxins
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