Status:
COMPLETED
The Benefit of Hemodialysis Plus Hemoperfusion on Mortality
Lead Sponsor:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborating Sponsors:
Shanghai Zhongshan Hospital
RenJi Hospital
Conditions:
End-stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 m...
Detailed Description
In this HD/HPvsHD trial, we plan to enroll 1364 maintenance hemodialysis patients. Eleven medical centers in Shanghai Metropolitan area have explicitly expressed interest to participate. Participants ...
Eligibility Criteria
Inclusion
- Patients must meet all of the following criteria are eligible:
- Age ≥ 18 years old
- Regular blood purification treatment at least 3 months before enrolled in this study
- 3\) Standard Kt/V ≥ 1.2
- Subjects with one of more of the following conditions will be excluded:
- White blood cell count \< 4×10\^9/L and / or platelet count \< 100×10\^9/L
- Cerebral hemorrhage in the past 12 weeks
- MACEs in the past 8 weeks
- Severe heart failure (New York Heart Association \[NYHA\] class IV)
- Active gastrointestinal bleeding, or coagulation dysfunction
- Malignant tumor
- Active infection
- Pregnancy or lactation 9) Mental disabilities
Exclusion
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
1362 Patients enrolled
Trial Details
Trial ID
NCT03227770
Start Date
December 1 2017
End Date
December 31 2021
Last Update
August 29 2022
Active Locations (11)
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1
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200000
2
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China, 200000
3
RenJi Hospital
Shanghai, Shanghai Municipality, China, 200000
4
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200000