Ignite Creation Date:
2024-05-06 @ 10:20 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03227770
Status:
COMPLETED
Last Update Posted:
2022-08-29
First Post:
2017-07-20
Brief Title:
The Benefit of Hemodialysis Plus Hemoperfusion on Mortality
Sponsor:
Xinhua Hospital Shanghai Jiao Tong University School of Medicine
Organization:
Xinhua Hospital Shanghai Jiao Tong University School of Medicine
Study Overview
Official Title:
A Randomized Open-label Multi-centre Trial Comparing Hemodialysis Plus Hemoperfusion Versus Hemodialysis Alone in Adult Patients With End-stage Renal Disease HDHPvsHD
Status:
COMPLETED
Status Verified Date:
2022-08
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:
This multi-center open-label randomized controlled trial aims to investigate the efficacy of hemoperfusion HP combined with hemodialysis HD by evaluating all-cause mortality and cardiovascular mortality in maintenance hemodialysis patients
Detailed Description:
In this HDHPvsHD trial we plan to enroll 1364 maintenance hemodialysis patients Eleven medical centers in Shanghai Metropolitan area have explicitly expressed interest to participate Participants will be randomized to receive hemodialysis plus hemoperfusion or hemodialysis alone at a 11 ratio after 1-month run-in period In both arms patients will receive lBlood purification including low-flux hemodialysis high-flux hemodialysis or hemodiafiltration treatment at least 10 hours per week In the experiment group in addition to the treatments in the control arm hemoperfusion will be conducted at least once every two weeks using a HA130 resin hemoperfusion apparatus containing 130ml resin Follow-up is scheduled at 3 6 12 18 24 and up to 48 months after randomization and will consist the following routine physical examinations standard lab panels blood routine liverkidney functions tests of the coagulation system etc chest X-ray electrocardiogram echocardiography heart function rating based on New York Heart Association grading Dialysis adequacy defined by standard KtV will be calculated Adverse events will be assessed according to the international conference on harmonization guidelines The primary outcomes will include 24-month all-cause mortality Secondary outcomes will include cardiovascular-related mortality the occurrence of major cardiovascular events and the quality of life Kidney Disease Quality of Life Short Form
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None