- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07348913
Impact of Regular Low-Frequency Hemoperfusion on Medium- to Long-Term Prognosis in Maintenance Dialysis Patients
Impact of Regular Low-Frequency Hemoperfusion on Medium- to Long-Term Prognosis in Maintenance Dialysis Patients: A Real-World Single-Center Retrospective Study
Objective: To investigate the effect of regular low-frequency hemoperfusion on all-cause mortality and cardiovascular/cerebrovascular mortality risk in maintenance hemodialysis (MHD) patients.
Methods: Data from MHD patients over the past 10 years at our blood purification center were retrospectively collected. Patients were divided into a hemoperfusion group (receiving regular low-frequency hemoperfusion once monthly) and a non-hemoperfusion group. Propensity score matching (PSM) was used to balance baseline characteristics. Differences in cumulative all-cause and cardiovascular/cerebrovascular mortality between the two groups before and after matching were compared. A competing risk model was employed to analyze mortality risk.
Study Overview
Status
Detailed Description
Clinical and laboratory data were collected for all enrolled patients. These included age, sex, underlying medical conditions, dialysis vintage, blood pressure, serum albumin, hemoglobin, platelet count, C-reactive protein (CRP), serum calcium, serum phosphorus, intact parathyroid hormone (iPTH), total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglycerides, and serum β2-microglobulin. Time-averaged mean values were calculated for blood pressure and laboratory parameters across the entire follow-up period. Data on cardiovascular/cerebrovascular death and all-cause mortality over the past ten years were also compiled.
Given the considerably larger size of the Hemoperfusion Group compared with the Non-Hemoperfusion Group, propensity score matching (PSM) was performed by specialized statisticians during data processing to balance baseline characteristics between the two groups. This approach enabled a systematic assessment of the effect of regular low-frequency hemoperfusion on cardiovascular/cerebrovascular and all-cause mortality in MHD patients.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Chongqing Municipality
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Chongqing, Chongqing Municipality, China, 400016
- First Affiliated Hospital of Chongqing Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- Included patients were aged ≥18 years
- Undergo dialysis treatment three times a week (each session lasting 3-4 hours)
- Having basically complete clinical and laboratory records, and having received at least 6 months of follow-up at this center
Exclusion Criteria:
- Under 18 years old
- Does not receive dialysis three times a week (each session lasts 3-4 hours)
- Does not have basic complete clinical and laboratory records, and has not been followed up at this center for at least 6 months
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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hemoperfusion group
receive regular low-frequency hemoperfusion once monthly
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non-hemoperfusion group
not receive regular low-frequency hemoperfusion once monthly
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Cardiovascular/Cerebrovascular Death
Time Frame: 1, 3, 5, and 10 years
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1, 3, 5, and 10 years
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all-cause mortality
Time Frame: 1, 3, 5, and 10 years
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1, 3, 5, and 10 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Chong qing Medical University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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