Uremia; ChronicNCT07335471
Prevention and Management of Cardiovascular and Cerebrovascular Complications in Maintenance Hemodialysis (MHD) Patients
A study testing Continuous High-Glucose Infusion and Regular Hemoperfusion in Maintenance Hemodialysis in people with Uremia; Chronic and Cardiovascular Diseases (CVD), run by Suzhou Municipal Hospital of Anhui Province at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Uremia; Chronic, Cardiovascular Diseases (CVD), Cerebrovascular Disorders
- What is being tested?
- Continuous High-Glucose Infusion and Regular Hemoperfusion in Maintenance Hemodialysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 20 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
Blood Purification Center, Suzhou Hospital Affiliated to Anhui Medical University
Suzhou, Anhui, 234000
About this study
Official title: A Comprehensive Intervention Program for Preventing Cardiovascular and Cerebrovascular Complications in Uremic Patients on Maintenance Hemodialysis
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.
Read more
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
- Being tested
- Continuous High-Glucose Infusion and Regular Hemoperfusion in Maintenance Hemodialysis
- Medical subject headings
- Uremia, Bronchiolitis Obliterans Syndrome, Cardiovascular Diseases, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous High-Glucose Infusion and Regular Hemoperfusion in Maintenance HemodialysisOther
hemoperfusion
| Study group | Role | What they receive |
|---|---|---|
| Continuous High-Glucose Infusion | Other | Not described Receives: Other: Continuous High-Glucose Infusion and Regular Hemoperfusion in Maintenance Hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Intradialytic Hypotension (IDH) Events
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.
Measured: 2 years
Dialysis Adequacy Measured by Single-Pool Kt/V
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.
Measured: 2 years
Dialysis Adequacy Measured by Urea Reduction Ratio (URR)
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 (%).
Measured: 2 years
Serum B-type Natriuretic Peptide (BNP) Level
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).
Measured: 2 years
Serum Levels of Phosphate, Calcium, and Intact Parathyroid Hormone (iPTH)
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.
Measured: 2 years
Severity of Uremic Pruritus
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.
Measured: 2 years
Treatment Failure Rate for Refractory Ultrafiltration Intolerance
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.
Measured: 2 years
Secondary outcomes (4)
Number of Participants with Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0
All adverse events occurring from the start of the study intervention until the end of follow-up will be recorded. Each event will be graded for severity and assessed for relationship to the study procedures according to the Common Terminology Criteria for Adverse Events version 5.0.
Measured: 2 years
Incidence of Acute Platelet Count Reduction and Periprocedural Hypersensitivity Reactions during Hemoperfusion
Two specific procedure-related events will be monitored: 1) Acute platelet reduction: defined as a decrease in platelet count by >30% from the pre-hemoperfusion value measured within 24 hours post-procedure. 2) Hypersensitivity reaction: defined as the occurrence of symptoms such as rash, hypotension, bronchospasm, or anaphylaxis during or within 2 hours after the hemoperfusion procedure.
Measured: 2 years
Peak Intradialytic Blood Glucose Level and Change in Pre-dialysis Fasting Glucose
Glucose levels will be monitored to assess metabolic perturbation. 1) Peak intradialytic glucose: the highest capillary blood glucose value (in mmol/L) recorded during any dialysis session with glucose infusion. 2) Fasting glucose change: the difference between the pre-dialysis fasting plasma glucose (in mmol/L) measured at the end of the study period and the baseline value.
Measured: 2 years
Number of Participants Who Permanently Discontinue the Study Intervention Due to an Adverse Event
This measure records participants who permanently stop receiving either the hemoperfusion or the continuous glucose infusion protocol specifically because of an adverse event, regardless of the event's severity or relationship assessment.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Jan 2023
- Primary completion31 Dec 2024
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uremia; ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Municipal Hospital of Anhui Province
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335471
- Sponsor's protocol ID
- SZH-CVRP-2023-01
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Intervention Program for Preventing Cardiovascular and Cerebrovascular Complications in Uremic Patients on Maintenance Hemodialysis
- ClinicalTrials.gov ID
- NCT07335471
- Acronym / sponsor ID
- SZH-CVRP-2023-01
- Conditions
- Uremia; Chronic, Cardiovascular Diseases (CVD), Cerebrovascular Disorders, Intradialytic Hypotension, Ultrafiltration Intolerance, Dialysis Adequacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Suzhou Municipal Hospital of Anhui ProvinceUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous High-Glucose Infusion | Other | Other: Continuous High-Glucose Infusion and Regular Hemoperfusion in Maintenance Hemodialysis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous High-Glucose Infusion and Regular Hemoperfusion in Maintenance Hemodialysishemoperfusion | Other | Continuous High-Glucose Infusion |
Primary outcome
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.
4 secondary outcomes
Number of Participants with Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0
Time frame: 2 years
Incidence of Acute Platelet Count Reduction and Periprocedural Hypersensitivity Reactions during Hemoperfusion
Time frame: 2 years
Peak Intradialytic Blood Glucose Level and Change in Pre-dialysis Fasting Glucose
Time frame: 2 years
Number of Participants Who Permanently Discontinue the Study Intervention Due to an Adverse Event
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: Yes
Related trials for Uremia; Chronic
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 4
Anrikefon vs Nalfurafine for Sleep Quality in Hemodialysis Patients With CKD-aP
Pruritus Chronic, Kidney Diseases, Chronic
Recruiting
Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets)
Chronic Kidney Disease (CKD) Stage 5, Kidney Dysfunction Requiring Dialysis (KDRD)
RecruitingObservational study
ICHARUS: Italian Cooperative HemoAdsorption Study for Relief of Uremic Symptoms
Chronic Kidney Disease 5D, Uremia; Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous High-Glucose Infusion and Regular Hemoperfusion in Maintenance Hemodialysis in people with Uremia; Chronic and Cardiovascular Diseases (CVD), run by Suzhou Municipal Hospital of Anhui Province at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Intradialytic Hypotension (IDH) Events (time frame: 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.