Combination of Hemodialysis With Hemoperfusion：A Clinical Study
June 22, 2018 updated by: Xiangmei Chen, Chinese PLA General Hospital
HA130 Hemoperfusion Apparatus Combined Hemodialysis to Improve Quality of Life in Patients Undergoing Maintenance Hemodialysis：A Perspective, Randomized, Controlled Multicenter Clinical Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
440
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100853
- Chinese PLA General Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: low flux hemodialysis
low flux hemodialysis alone, 3 times a week, 4 hours per session
|
|
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Experimental: high flux hemodialysis
high flux hemodialysis alone, 3 times a week, 4 hours per session
|
|
|
Experimental: low flux hemodialysis + hemoperfusion
low flux hemodialysis 2times a week and the HD+HP once a week
|
Other Names:
|
|
Experimental: high flux hemodialysis + hemoperfusion
high flux hemodialysis 2times a week and the HD+HP once a week
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Clearance rate of uremic toxins
Time Frame: 0,3,6,12 months
|
0,3,6,12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evaluation of quality of life
Time Frame: 0,3,6,12 months
|
0,3,6,12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2015
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
June 2, 2015
First Submitted That Met QC Criteria
June 2, 2015
First Posted (Estimate)
June 3, 2015
Study Record Updates
Last Update Posted (Actual)
June 26, 2018
Last Update Submitted That Met QC Criteria
June 22, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2014-011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.