A Comprehensive Intervention Program for Preventing Cardiovascular and Cerebrovascular Complications in Uremic Patients on Maintenance Hemodialysis
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Incidence of Intradialytic Hypotension (IDH) Events
Overview
Brief Summary
Background and Purpose: This clinical study aims to explore and validate two innovative treatment strategies to address two major challenges faced by patients on maintenance hemodialysis (uremia): the high incidence of cardiovascular and cerebrovascular complications and the common occurrence of ultrafiltration intolerance/refractory intradialytic hypotension.
Study Design: The research consists of two main parts, employing a prospective, interventional design.
Hemoperfusion (HP) for Cardiovascular/Cerebrovascular Complications: The investigators plan to enroll approximately 200 uremic patients on dialysis at the study center. Initially, a detailed survey of their existing cardiovascular health status and related risk factors will be conducted. Subsequently, a standardized hemoperfusion treatment platform will be established and evaluated, observing its effects on removing relevant toxins and improving biochemical markers. Finally, a subset of patients who have already developed such complications will be invited to participate in a comparative study. They will be randomly assigned to receive either conventional dialysis or conventional dialysis combined with intensified hemoperfusion therapy to systematically assess the efficacy and safety of the combined regimen.
Continuous High-Glucose Infusion for Ultrafiltration Intolerance: For patients suffering from severe ultrafiltration intolerance and refractory hypotension during glucose-free dialysis that does not respond to standard therapies (36 patients have been enrolled), an interventional study was conducted. Patients received a continuous infusion of 50% glucose solution during dialysis, supplemented by glucose boluses as needed. The study primarily observed whether this protocol could safely extend dialysis duration, increase ultrafiltration volume, and improve dialysis adequacy and related symptoms.
Participants: The study will be conducted at the Blood Purification Center of Suzhou Hospital. The main participants are adults aged 18 or older, diagnosed with uremia and receiving maintenance hemodialysis. For the cardiovascular/cerebrovascular part, patients must meet specific inclusion criteria; for the ultrafiltration intolerance part, patients must be diagnosed with refractory intradialytic hypotension unresponsive to standard therapy.
Study Procedures: All participants will provide informed consent before joining the study. The study will collect patient medical history, conduct physical examinations, blood tests, and questionnaires according to the protocol. Patients receiving hemoperfusion or high-glucose infusion interventions will undergo close monitoring of vital signs and efficacy evaluations before and after treatment. Some participants may be scheduled for regular follow-up to understand their long-term outcomes.
Potential Benefits and Risks: Participants may benefit directly from the study, for example: through the new treatment strategies, they may achieve better control of cardiovascular risks, reduce discomfort associated with hypotension (such as dizziness and cramping), and increase ultrafiltration volume and adequacy per session, potentially improving quality of life and long-term health outcomes. The risks involved are primarily routine medical risks associated with hemoperfusion or intravenous glucose infusion, such as bleeding or infection at the puncture site, blood glucose fluctuations, etc. All procedures will be performed by experienced medical staff under strict supervision to maximize patient safety.
Social Significance: The results of this study are expected to provide clinicians with new, evidence-based treatment options for managing the complex and challenging complications in uremic dialysis patients. If proven effective and safe, these protocols may be incorporated into clinical practice guidelines, helping more patients achieve adequate and comfortable dialysis, ultimately improving patient prognosis and quality of life.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 18 and 80 years.
- •Receiving maintenance hemodialysis (MHD) for 3 months or longer.
- •Diagnosis of severe ultrafiltration intolerance (UFI), defined as either:
- •Persistent pre-dialysis hypotension (systolic blood pressure \<100 mmHg), OR
- •Recurrent intradialytic hypotension (IDH), defined per KDOQI guidelines as a decrease in systolic blood pressure to \<90 mmHg or by \>20 mmHg from baseline, accompanied by symptoms.
- •Failure to achieve target ultrafiltration volume (mean UFV \<1.5 L per session) despite at least 4 weeks of conventional interventions (e.g., dialysate cooling, sodium profiling, sequential ultrafiltration).
- •Inadequate dialysis delivery, defined as a mean single-pool Kt/V of less than 1.2.
Exclusion Criteria
- •Acute infection, myocardial infarction, or major surgery within the past 3 months.
- •Uncontrolled diabetes mellitus, defined as a glycated hemoglobin (HbA1c) level greater than 9%.
- •Severe liver dysfunction (Child-Pugh class C).
Arms & Interventions
Continuous High-Glucose Infusion
Intervention: Continuous High-Glucose Infusion and Regular Hemoperfusion in Maintenance Hemodialysis (Other)
Outcomes
Primary Outcomes
Incidence of Intradialytic Hypotension (IDH) Events
Time Frame: 2 years
This primary outcome measure assesses the frequency of intradialytic hypotension events during hemodialysis sessions. IDH is strictly defined as a systolic blood pressure drop of ≥20 mmHg or a mean arterial pressure drop of ≥10 mmHg, accompanied by clinical symptoms (e.g., dizziness, nausea, cramps) requiring nursing intervention. The measure will be reported as the number of IDH events per patient per dialysis session, calculated from nursing records and continuous blood pressure monitoring data throughout the intervention period.
Dialysis Adequacy Measured by Single-Pool Kt/V
Time Frame: 2 years
This measure assesses the efficacy of solute clearance during hemodialysis using the single-pool Kt/V formula, which is calculated based on pre- and post-dialysis blood urea nitrogen levels, dialysis duration, and ultrafiltration volume. A higher Kt/V value indicates more adequate dialysis.
Dialysis Adequacy Measured by Urea Reduction Ratio (URR)
Time Frame: 2 years
This measure assesses dialysis efficacy by the percentage reduction of blood urea nitrogen during a treatment session. URR is calculated from pre- and post-dialysis urea nitrogen levels. It is reported as a percentage (%).
Serum B-type Natriuretic Peptide (BNP) Level
Time Frame: 2 years
This measure evaluates the change in cardiac load and fluid status by assessing serum BNP concentration. Blood samples will be collected at baseline and post-intervention for analysis. It is reported in picograms per milliliter (pg/mL).
Serum Levels of Phosphate, Calcium, and Intact Parathyroid Hormone (iPTH)
Time Frame: 2 years
This measure evaluates changes in mineral and bone metabolism. Fasting blood samples will be collected at baseline and at scheduled intervals during the intervention period. Serum phosphate and calcium levels will be measured using standard laboratory biochemical analyzers, reported in mmol/L. Serum iPTH level will be measured using electrochemiluminescence immunoassay, reported in pg/mL.
Severity of Uremic Pruritus
Time Frame: 2 years
This measure assesses the intensity of dialysis-related itch. The severity of pruritus will be evaluated by patients using a validated Visual Analogue Scale (VAS), ranging from 0 (no itch) to 10 (worst imaginable itch). The assessment will be recorded weekly during dialysis sessions throughout the study period. The outcome will be reported as the mean VAS score.
Treatment Failure Rate for Refractory Ultrafiltration Intolerance
Time Frame: 2 years
This measure evaluates the clinical efficacy in managing ultrafiltration intolerance. Treatment failure is operationally defined as the inability to complete the prescribed dialysis duration or to achieve the target ultrafiltration volume due to intradialytic hypotension (IDH) that is unresponsive to the study's glucose infusion protocol, necessitating early session termination. This binary outcome (Yes/No) will be determined per dialysis session based on nursing and medical records.
Secondary Outcomes
- Number of Participants with Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0(2 years)
- Incidence of Acute Platelet Count Reduction and Periprocedural Hypersensitivity Reactions during Hemoperfusion(2 years)
- Peak Intradialytic Blood Glucose Level and Change in Pre-dialysis Fasting Glucose(2 years)
- Number of Participants Who Permanently Discontinue the Study Intervention Due to an Adverse Event(2 years)