Combination of Hemodialysis With Hemoperfusion：A Clinical Study
HA130 Hemoperfusion Apparatus Combined Hemodialysis to Improve Quality of Life in Patients Undergoing Maintenance Hemodialysis：A Perspective, Randomized, Controlled Multicenter Clinical Study
1 other identifier
interventional
440
1 country
1
Brief Summary
This study is a prospective, randomized, controlled multicenter clinical study. The aim of the study is to investigate whether the combination of maintenance hemodialysis (MHD) with hemoperfusion (HP) could improve the clearance rate of middle and large molecule uremic toxins so as to improve the quality of life of MHD patients and reduce their mortality rate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 2, 2015
CompletedFirst Posted
Study publicly available on registry
June 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJune 26, 2018
June 1, 2018
2.5 years
June 2, 2015
June 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clearance rate of uremic toxins
0,3,6,12 months
Secondary Outcomes (1)
Evaluation of quality of life
0,3,6,12 months
Study Arms (4)
low flux hemodialysis
EXPERIMENTALlow flux hemodialysis alone, 3 times a week, 4 hours per session
high flux hemodialysis
EXPERIMENTALhigh flux hemodialysis alone, 3 times a week, 4 hours per session
low flux hemodialysis + hemoperfusion
EXPERIMENTALlow flux hemodialysis 2times a week and the HD+HP once a week
high flux hemodialysis + hemoperfusion
EXPERIMENTALhigh flux hemodialysis 2times a week and the HD+HP once a week
Interventions
Eligibility Criteria
You may qualify if:
- Age≥18, male or female
- Maintenance hemodialysis duration\>3 months
- Regular hemodialysis,3 times a week,4 hours per session
- Vascular access unlimited
- iPTH≥300pg/ml
- Sign the written informed consent
You may not qualify if:
- Allergic to dialysis equipment
- PLT\<60×10\^9/L
- Blood flow\<200ml/min
- Serum albumin\<30g/L
- Kt/V\<1.2
- iPTH\>800pg/ml
- Hemodiafiltration
- Coagulation disorder, severe bleeding tendency, with active bleeding
- Severe hypotension, severe cardiopulmonary insufficiency
- Under other drug trial
- Acute infection, severe heart, lung, liver, nervous diseases, malignant tumor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor,Chief physician,Academician of Chinese Academy of Engineering,Chinese PLA General Hospital
Study Record Dates
First Submitted
June 2, 2015
First Posted
June 3, 2015
Study Start
June 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
June 26, 2018
Record last verified: 2018-06