Prevention and Management of Cardiovascular and Cerebrovascular Complications in Maintenance Hemodialysis (MHD) Patients

NCT ID: NCT07335471

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-07-20

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.

Conditions

Uremia; Chronic; Cardiovascular Diseases (CVD); Cerebrovascular Disorders; Intradialytic Hypotension; Ultrafiltration Intolerance; Dialysis Adequacy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Continuous High-Glucose Infusion

Group Type: OTHER

Continuous High-Glucose Infusion and Regular Hemoperfusion in Maintenance Hemodialysis

Intervention Type: OTHER

hemoperfusion

Interventions

Continuous High-Glucose Infusion and Regular Hemoperfusion in Maintenance Hemodialysis

hemoperfusion

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age between 18 and 80 years.

2. Receiving maintenance hemodialysis (MHD) for 3 months or longer.

3. 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.

4. 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).

5. Inadequate dialysis delivery, defined as a mean single-pool Kt/V of less than 1.2.

Exclusion Criteria

1. Acute infection, myocardial infarction, or major surgery within the past 3 months.

2. Uncontrolled diabetes mellitus, defined as a glycated hemoglobin (HbA1c) level greater than 9%.

3. Severe liver dysfunction (Child-Pugh class C).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Municipal Hospital of Anhui Province

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Blood Purification Center, Suzhou Hospital Affiliated to Anhui Medical University

Suzhou, Anhui, China

Countries

China

Other Identifiers

SZH-CVRP-2023-01

Identifier Type: -

Identifier Source: org_study_id