Cardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls
NCT07686978
Chronic Disease, Disease Attributes
Ankara, Turkey (Türkiye)
View Trial DetailsNCT Number: NCT06981559
The goal of this real-world clinical trial study is to evaluate the impact of hemoperfusion on the prognosis of patients with End-Stage Renal Disease (ESRD) undergoing maintenance hemodialysis.
Trial opening soon.
Get Notified18 year–85 year
All sexes
Observational
The investigators are planning to conduct a real-world clinical trial study, enrolling patients with maintenance hemodialysis (MHD) from Huashan Hospital. Patients will be divided into two groups based on their hemoperfusion (HP) treatment frequency: high-frequency HP treatment group (≥1 session every 2 weeks) and low-frequency HP treatment group (<1 session every 2 weeks). The investigators will collect baseline demographic data, cardiovascular events, cognitive function status, and nutrition-related clinical indicators for both groups. After a 3-year follow-up, The investigators will reassess these parameters to explore the impact of HP on the prognosis of MHD patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients undergoing maintenance hemodialysis for ≥3 months Aged ≥18 years and <85 years; Regular hemodialysis treatment, 3 times per week No residual renal function (urine output <200 mL/d); Written informed consent has been obtained from the participant.
Exclusion criteria
Patients with severe cerebrovascular diseases (new-onset cerebral infarction, cerebral hemorrhage) or neurological diseases (autoimmune encephalitis, epilepsy, neurodevelopmental disorders).
Patients with acute severe infections (such as sepsis), severe cardiopulmonary insufficiency (NYHA class IV heart failure, acute exacerbation of COPD), or malignancies.
Patients receiving combined hemodialysis and peritoneal dialysis treatment. Patients with allergic reactions, contraindications, or intolerance to dialysis membrane materials.
Patients with a platelet count <60 × 10^9/L. Other conditions deemed by the investigators as unsuitable for participation in this study.
Time frame: month 12 and month 36
Montreal Cognitive Assessment: A score of 24 or higher is considered normal, while a score below 24 may indicate mild cognitive impairment(MCI)
Time frame: month 12 and month 36
Number of participants with cardiovascular events including myocardial infarction, stroke, hospitalization for heart failure, or cardiovascular death
Time frame: month 12 and month 36
ASMI (kg/m2) will be calculated as ASM(kg)/height 2(m2). ASM will be measured using bioimpedance analysis (BIA)
Time frame: month 12 and month 36
Decline rate of β2-MG from baseline level
Time frame: month 12 and month 36
spKt/V
Time frame: month 12 and month 36
Decline rate of IL-6 from baseline level
Time frame: month 12 and month 36
Decline rate of proteomics and metabolomics from baseline levels
Time frame: month 12 and month 36
URR
Time frame: month 12 and month 36
electrolytes (potassium)
Time frame: month 12 and month 36
electrolytes (sodium)
Time frame: month 12 and month 36
electrolytes (calcium)
Time frame: month 12 and month 36
electrolytes (phosphorus)
xujiao chen
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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