Hemodialysis

The goal of the CSP-2002 clinical trial is to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis (HD) access in patients with end-stage renal disease (ESRD). The primary study endpoints are: Primary Effectiveness Endpoint: The proportion of subjects with secondary patency at 6 months. Primary Safety Endpoint: The incidence of device-related adverse events of special interest (AESIs) through 6 months. Participants will be asked to sign an informed consent form. Once enrolled, they will be assessed to receive the study graft implant and asked to participate in periodic follow-up visits and assessments through 2 years following implant.

The purpose of this randomized controlled trial is to determine the optimal exercise duration of a combined exercise program (aerobic + resistance) in patients undergoing hemodialysis by evaluating its effects on dialysis adequacy, fatigue, depression, VO2 max, muscle strength, physical functioning, and QOL in patients undergoing hemodialysis.

Among adults receiving in-center hemodialysis, young and middle-aged women (aged 18 to 49) have the highest hospitalization rates at 1.8 per person-year. Sex differences are most pronounced in this age group, even after accounting for multiple confounding factors, including comorbidities, primary insurance type, and length of time on dialysis. Sex differences exist across racial groups and within high-poverty communities. For example, women aged 18 to 49 who receive in-center hemodialysis and live in Baltimore City experience 2.9 hospital admissions per year compared to 1.2 admissions per year in men. Moreover, sex differences reflect underlying health - sex differences are markedly attenuated when comparing women and men with similar levels of systemic inflammation. Community health worker (CHW) models are an evidence-based approach to reduce acute care utilization, but have not been widely implemented in dialysis or targeted risk factors unique to young and middle-aged women receiving dialysis in high-poverty communities. The proposed study will address this gap by pilot testing a CHW service adapted for this population.

Chronic kidney disease (CKD) patients undergoing maintenance hemodialysis experience profound alterations in their gut microbiota, leading to dysbiosis and increased gut permeability. This disruption facilitates the translocation of endotoxins and gut-derived uremic toxins such as indoxyl sulfate and p-cresyl sulfate into the systemic circulation, contributing to heightened systemic inflammation, cardiovascular disease risk, and accelerated CKD progression. Synbiotic supplementation, particularly multispecies formulations, has emerged as a promising therapeutic strategy to restore gut microbial balance, enhance intestinal barrier integrity, and reduce the systemic burden of deleterious microbial metabolites. These probiotics potentially improve clinical outcomes by modulating inflammatory pathways and decreasing circulating levels of uremic toxins. Despite these insights, few clinical trials have comprehensively assessed the effects of multispecies synbiotic on fecal microbiome composition, gut permeability and uremic toxin profiles in hemodialysis patients. This pilot study aims to fill this gap by evaluating the modulatory effects of a 12-week multispecies synbiotic intervention.

The goal of this clinical trial is to evaluate the health effects of expanded hemodialysis in patients receiving hemodialysis. The main question it aims to answer is: 1\) Does expanded hemodialysis reduce the risk of death from any cause? Researchers will compare expanded hemodialysis to conventional hemodialysis (the treatment currently used for the majority of patients receiving hemodialysis) to see if expanded hemodialysis works to improve patient outcomes. Participants will continue to receive their regularly scheduled hemodialysis treatments using either a super high-flux/expanded dialysis filter or a high-flux/conventional dialysis filter. All other aspects of treatments remain the same. No additional tests or visits are required. Data will be obtained using administrative healthcare databases and medical record review (at a subset of participating locations).

In this observational study, the investigators evaluate the influencing factors of cerebrovascular disease and cognition in hemodialysis patients.

End-stage kidney disease requiring hemodialysis is a chronic condition with substantial clinical, functional, and psychosocial burden. Maintaining an adequate health status between dialysis sessions depends largely on patients' ability to self-manage key aspects of treatment, including fluid restriction, dietary control, and vascular access care. Adherence in this population remains frequently suboptimal, and elevated interdialytic weight gain (IDWG), hyperphosphatemia, and hyperkalemia are among the most common complications associated with non-adherence. DialysisBot is a multiplatform, artificial intelligence-based conversational agent designed to support hemodialysis patients in the day-to-day self-management of their disease. The system combines a generative large language model for natural dialogue management, a fine-tuned BERT classifier for recognizing the domain of each patient request (diet, fluid intake, vascular access care, or organizational aspects of dialysis), and a vector-similarity retrieval engine that limits every response to a clinically validated knowledge base preloaded by the research team and approved by the hospital institution. The system performs no autonomous web search. When the cosine similarity between a user query and the indexed reference documents falls below a predefined threshold, the system withholds a clinical answer and instead informs the patient that it cannot respond, directing them to contact healthcare staff; this mechanism is the main technical safeguard against hallucinated or unvalidated responses. This is a prospective experimental pilot study evaluating the feasibility, acceptability, impact, and user satisfaction associated with DialysisBot as a self-management support tool for patients undergoing hemodialysis. Secondary objectives include assessing support for dietary management (phosphorus, potassium, and sodium restriction), support for interdialytic fluid intake control, whether system-provided guidance on vascular access management (arteriovenous fistula and central venous catheter) is put into practice and consistent with current standards of care, the impact on treatment adherence, and the barriers, facilitators, and overall user experience associated with the intervention. The study is organized into two methodological phases: a quantitative longitudinal phase (T0 baseline, T1 at 1 month, T2 at 3 months) using standardized patient-reported outcome measures and routine clinical parameters, followed by a qualitative phase conducted after T2, based on semi-structured interviews analyzed through reflexive thematic analysis. A convenience sample of 20-40 adult patients undergoing chronic hemodialysis, recruited through a participating dialysis center and/or an online patient community, will be enrolled and trained on the application before use. As a pilot feasibility study, its results are intended to inform the design and sample size of future, larger-scale confirmatory trials.

The goal of this clinical trial is to find out if using a citrate-based dialysate with added magnesium during hemodialysis can help slow down or prevent the hardening of blood vessels (vascular calcification) in adults on long-term dialysis. The main questions the study will try to answer are: Does citrate-based dialysate with magnesium improve the blood's ability to prevent calcium buildup (measured by a test called T50) compared to acetate-based dialysate? Does it modify magnesium, calcium and parathyroid hormone (PTH) levels in the blood? Does it lower the chances of heart problems or death? Researchers will compare two groups: one will receive acetate-based dialysate, and the other will receive citrate-based dialysate with magnesium. Participants will: Receive one of the two types of dialysate during their regular hemodialysis sessions for 12 months Have regular blood tests Be monitored for any heart problems and for overall health during the study

The purpose of this study is to assess the efficacy of prophylactic antibiotic treatment on blood stream infections and severe culture negative infections, in patients on newly started hemodialysis(HD), with a central venous catheter as vascular access.

This study will evaluate whether inspiratory muscle training performed during hemodialysis improves inspiratory muscle strength in adults receiving regular hemodialysis. After an initial 12-week period without study-protocolized inspiratory muscle training, participants will be randomly assigned to inspiratory muscle training plus usual care or usual care alone for 12 weeks. The primary outcome is the change in maximum inspiratory pressure from baseline to Week 12. The study will also assess lung function, walking capacity, handgrip strength, electrical activity of inspiratory muscles, dyspnea, body composition, health-related quality of life, and daily physical activity.

In connection with dialysis treatment, fluid and salt balance changes. Some kidney disease patients experience fluid accumulation in the body and need to have excess fluid removed via the dialysis machine. Others have too little fluid in their bodies and experience general symptoms. The amount of fluid that needs to be removed is an individual assessment and can be difficult to determine. Today, fluid removal is determined based on signs such as water in the lungs, swollen legs, and blood pressure. By using a so-called bioimpedance spectroscopy (BIS) device, it os possible measure how much fluid is in the body. However, the calculations that BIS devices use are developed for healthy individuals and do not work optimally during dialysis. Therefore, the investigators will use the actual measurements and compare them with fluid extraction and weight changes to examine their relationship. Hemodialysis patients with ultrafiltration on 3 consecutive dialysis days in order to investigate whether there is a difference in measurements after the long dialysis break and whether the measurements are the same when you are being drawn to your dry weight are included. Other patients without fluid removed during dialysis will be investigated once. I the study the absolute blood volume is also measured, that is, how much fluid is in the bloodstream. This is also an expression of the body's total fluid volume. By combining the various measurements, the study will gain increased knowledge about your hydration status. If the measurement methods have sufficient precision, the use of BIS and measurement of total blood volume may contribute to a more accurate determination of your dry weight.

The goal of this clinical trial is to evaluate whether a structured family conversation intervention can be delivered in a feasible and acceptable way to adults living with chronic kidney disease (CKD) and their family members. The study will also explore whether the intervention and study procedures are suitable for a future larger clinical trial. The main questions it aims to answer are: Can adults with CKD and their family members be successfully recruited, enrolled, and retained throughout the study? Is the Family Time intervention acceptable and practical for patients, family members, and healthcare professionals? Are the study procedures and selected questionnaires appropriate for evaluating a future larger trial? Does the intervention show potential to support family functioning and well-being? Researchers will compare the Family Time intervention plus usual care with usual care alone. Participants will: Complete questionnaires before and after the study period. Be allocated to either the Family Time intervention or usual care. If allocated to the intervention group, participate in three structured family conversations over approximately 8 weeks, with the option of one additional follow-up conversation. If allocated to the intervention group, be invited to take part in an interview about their experiences after completing the intervention.

The purpose of this study is to evaluate the effectiveness of low-level laser therapy (LLLT) compared with isometric handgrip exercise and standard care in promoting vascular remodeling of arteriovenous fistulas (AVFs) among hemodialysis patients.

This planned randomized controlled trial will enroll 164 patients undergoing hemodialysis to compare the effectiveness of leg massage versus vibration therapy on muscle cramps and patient comfort. Participants will be randomly assigned to one of three groups: a massage group receiving 20-minute lower extremity massage sessions, a vibration group receiving 10-minute vibration therapy, or a control group receiving standard care only. All interventions will be administered three times per week for two weeks (six sessions). The study will evaluate cramp frequency, cramp severity using a Visual Analog Scale, sleep quality through the Pittsburgh Sleep Quality Index, and patient comfort scores. Both interventions are expected to significantly reduce cramp frequency and severity compared to standard care, with massage anticipated to show superior benefits for sleep quality and home-based cramp reduction, while vibration is expected to provide better immediate comfort during dialysis sessions. No serious adverse events are predicted. The findings will help healthcare providers offer personalized, evidence-based non-pharmacological options to improve quality of life for hemodialysis patients.

People with end-stage kidney disease who receive hemodialysis are often told to strictly limit foods high in potassium, such as fruits, vegetables, legumes, nuts, and whole grains. This advice is intended to prevent high blood potassium levels (hyperkalemia), which can cause dangerous heart rhythm problems. However, these restrictions can make eating difficult, reduce diet quality, and lower quality of life. New research suggests that not all sources of potassium affect the body in the same way. Potassium added to highly processed foods is more easily absorbed than potassium naturally found in whole foods like fruits and vegetables. Large studies have found little evidence that eating potassium-rich whole foods increases blood potassium levels in people on dialysis. Clinical guidelines are beginning to shift, but no high-quality clinical trial has tested whether a more flexible, food-based approach is safe for people receiving hemodialysis. This study will compare two dietary approaches in 148 adults on hemodialysis: the usual low potassium diet and a "liberalized" potassium diet that encourages minimally processed foods while limiting highly processed foods with potassium additives. Participants will receive dietitian support and grocery assistance for 12 weeks. The investigators will closely monitor blood potassium levels to ensure safety. The investigators will also examine whether the liberalized diet is as safe as standard care, and whether it improves diet quality and quality of life. The investigators will also study factors that influence the participant's ability to follow the diet in real-world settings. If safe, this approach could reduce unnecessary food restrictions, improve diet quality, and enhance quality of life for people receiving hemodialysis, while maintaining patient safety.

Hemodialysis patients may experience dialysis-related distress due to long-term treatment requirements, dietary and fluid restrictions, medication use, vascular access problems, dialysis-related symptoms, and psychosocial challenges. Nurse-led self-management programs may help patients improve dialysis self-management, reduce distress, and support treatment adherence. This study aims to evaluate the effect of a nurse-led needs-based dialysis self-management program on dialysis-related distress in patients receiving hemodialysis. The study will be conducted as a single-center, two-arm, parallel-group, randomized controlled trial. A total of 100 adult hemodialysis patients will be randomly assigned to either the intervention group or the control group in a 1:1 ratio. Participants in the intervention group will receive a 6-week nurse-led needs-based dialysis self-management program in addition to routine hemodialysis care. Participants in the control group will continue routine hemodialysis care. Data will be collected at baseline, 6 weeks, and 18 weeks. The primary outcome is dialysis-related distress. Secondary outcomes include illness and treatment uncertainty, treatment adherence, and clinical adherence indicators.

The aim of our study is to evaluate the impact of repeated episodes of ischemic quenching on changes in blood pressure, heart rate and laboratory parameters of inflammation in patients with kidney diseases. There is credible evidence that intentionally producing periods of ischemia provides protection of the myocardium and blood vessels against subsequent ischemic injury. The examination will be performed during hospitalization in the Department of Nephrology, Hypertension, Transplantology and Internal Diseases and will last 4 days. On the first day, blood pressure will be measured using an automatic blood pressure monitor, radial artery pulse, blood saturation will be measured using a pulse oximeter, and approximately 6 ml of venous blood will be collected from the elbow bend area for laboratory tests. Then, compression of the lower limb below the knee will be performed using a blood pressure cuff. Four 5-minute cycles of inflation and deflation of the cuff will be performed. The pressure on the lower limb will be repeated on the next two days. On the last day of the examination, blood pressure, heart rate and blood saturation will be measured again, and approximately 6 ml of venous blood will be collected again for laboratory tests.

This expected prospective randomized control trial study will involve 60 haemodialysis patients with neck pain. The patients in the experimental group (E) will subject, medical treatment besides acupuncture laser therapy. Medical treatment will be used in the control group (C). Pain and quality of life assessment will be used in the assessment of outcome.

Many people who have kidney failure require hemodialysis treatments to stay alive. Hemodialysis is a procedure that cleans the blood of the toxins and fluids that build up when kidneys don't work. Most patients receive hemodialysis treatment three times every week and each treatment lasts 4 hours. These patients spend 156 days per year receiving hemodialysis treatments. This is a very large time burden which has a tremendous impact on well-being and life satisfaction. Current usual approach of prescribing three hemodialysis treatments per week is not based on good studies and assumes that all people need the same number of hemodialysis treatments per week regardless of their age, values, life expectancy or other health conditions. Over time, increasingly more elderly people are needing to start hemodialysis treatments. The investigators have conducted a preliminary study that shows that patients who are 70 years of age or older can do well when only receiving only two hemodialysis treatments per week. In this preliminary study, receiving two hemodialysis treatments per week was no different than three hemodialysis treatments per week with regards to important safety measures including blood values and management of body fluid levels. The investigators now propose to carry out a much larger study in many centers across Canada that will compare two times per week hemodialysis treatments to three times per week hemodialysis treatments in elderly patients who have reached kidney failure and are beginning their hemodialysis journey. The investigators want to know if receiving hemodialysis treatments twice per week increases the number of days that a patient is able to spend at home without increasing rates of hospitalization or death compared to receiving hemodialysis treatments three times per week. The investigators also want to know if this is better for people's quality of life, safe, less expensive for the health care system and friendlier to the environment. The results of this study will help elderly patients needing to start hemodialysis treatments, medical care teams who help make decisions about how many hemodialysis treatments per week are necessary as well as kidney organizations that oversee kidney care for patients in Canada and around the world.

Pulmonary hypertension (PH) is a frequent and clinically significant complication in patients with end-stage kidney disease (ESKD) undergoing maintenance hemodialysis (HD). However, PH assessment in this population is often confounded by volume overload, leading to potential overestimation and misclassification. This prospective, multicenter observational study aims to evaluate the prevalence, phenotype, and predictors of PH in HD patients under standardized euvolemic conditions. A structured pretrial phase including volume assessment and correction will be performed prior to echocardiographic evaluation, which will be conducted after confirmation of euvolemia, post-hemodialysis or on the following day. In participants with echocardiographic findings suggestive of PH, right heart catheterization may be performed when clinically indicated and after obtaining specific informed consent. The study integrates clinical, biological, dialysis-related, and echocardiographic data to provide a comprehensive characterization of PH in a well-defined ESKD population.

The goal of this clinical trial is to evaluate the feasibility of two different preoperative hemodialysis schedules for people with end-stage kidney disease (ESKD) who undergo surgical procedures. The main questions it aims to answer are: Is it feasible to randomize participants with ESKD undergoing nonemergent surgical procedures to same-day hemodialysis versus no same-day hemodialysis? Is it safe to randomize participants with ESKD undergoing nonemergent surgical procedures to same-day hemodialysis versus no same-day hemodialysis? Researchers will compare the two hemodialysis schedules to see if the scheduling and safety profiles are the same. Participants will: Answer questions about their health up to 4 weeks before and 4 weeks after the surgical procedure. Receive hemodialysis on the day of the surgical procedure or not, depending on the study treatment assignment.

This randomised controlled study aims to evaluate the effects of mindfulness meditation on sleep quality, perceived stress and symptoms levels ion hemodialysis patients. Participants in the intervention group will receive a 4 week mindfulness meditation program in addition to routine care. Outcomes will be assessed before and after the intervention using validated measurement tools.

The objective of this study is to evaluate the effects of royal jelly on inflammation and cellular senescence in patients with chronic kidney disease (CKD) on hemodialysis (HD).

Kidney failure is common. In some people the ability of the kidneys to clean poisons out of the blood gets so low they need to be hooked up to a machine three times a week to do it for them. This is called dialysis. Unfortunately, although this treatment removes those waste products, people who need dialysis die much more often than people who don't need dialysis. Dialysis causes extreme stress on the body and leads to many organs being damaged. Removing fluid from the body quickly causes the equivalent of repeated little heart attacks or little strokes in the brain. Many patients struggle to tolerate having all the fluid that they have drunk since their last dialysis session removed- without unpleasant symptoms of dangerously low blood pressure (which makes the damage worse). Dialysis treatments can be done more slowly or more often, but that means having to spend a lot more time at the hospital and is difficult for the health system to be able to provide the extra treatment time. Could extra fluid be removed in between dialysis sessions? Up to now there has not been a way to effectively do this. Investigators have now designed and built an entirely new, very small and very simplified, device that can do part of what a dialysis machine does. It doesn't clean the blood or replace the need for conventional dialysis sessions, but it can provide additional and gentle removal of fluid which wasn't able to be taken off during a standard treatment session. If this study is successful, it will be the first time that a wearable device has been successfully built and used to take off extra fluid when dialysis patients are not in the hospital. The ability to do this opens up the possibility of, 1) helping to treat patients (both making people feel better and live longer) who can't tolerate getting off all the fluid in the short 3-4 hours they are on the dialysis machine in the hospital, and 2) helping patients who feel OK having the fluid taken off but are silently being subjected to damage to their organs due to the rapid removal, have reduced damage.

Background and problem Chronic kidney disease (CKD) affects a large share of adults worldwide and is a growing public-health concern. People with advanced CKD can develop "uremia", a dangerous build-up of waste products in the blood that the failing kidneys cannot remove. Even when patients receive regular dialysis, many so-called "uremic toxins" remain in the body because some of these substances bind tightly to blood proteins and are poorly removed by dialysis. Over 100 uremic toxins have been identified and classified and protein-bound toxins such as Indoxylsulfate and p-Cresylsulfate are especially difficult to clear by dialysis. Some uremic toxins are linked to heart and blood-vessel disease, inflammation, and worse outcomes in dialysis patients. For example, Indoxylsulfate has been associated with higher mortality, vascular calcification, vessel stiffness and heart failure. Reducing these toxins might therefore improve quality of life and lower cardiovascular risk in people on dialysis. Purpose of the study The study will test whether adding inner, fermentable pea fiber (a natural prebiotic) to the daily diet of hemodialysis patients can lower blood levels of uremic toxins-especially Indoxylsulfate-and improve related markers of inflammation and cardiovascular risk. The investigators hypothesize that fermentable fibers change gut bacterial composition so that less toxin-forming bacterial metabolism (from amino acids like tryptophan) occurs, thereby reducing the amount of harmful metabolites that reach the blood. Type of study: Randomized, double-blind, controlled trial with two groups. Duration: 8 weeks of intervention. Intervention: Participants will receive daily baked goods (bread, rolls, muffins, scones, pizza bread) that together provide 20 g of pea fiber per day; the control group will receive identical foods without added pea fiber. The fiber mix uses commercially available inner pea-fiber products. Blood and stool sampling: Blood samples are taken before the intervention, at 4 weeks and at 8 weeks to measure Indoxylsulfate and other toxins, inflammation markers, vitamin D metabolites and cardiovascular risk markers. A subgroup will also provide stool samples to study changes in the gut microbiome. Who can join Adults aged 18-89 who have been on chronic hemodialysis for at least three months and receive dialysis two to three times per week are eligible. The study excludes people with recent serious infections, advanced liver disease, active cancer, recent blood transfusion, pregnancy, certain food intolerances or inability to consent. Each study arm will include 36 participants. Primary and secondary outcomes Primary outcome: Change in blood Indoxylsulfate concentration between the pea-fiber group and the control group. Secondary outcomes: Levels of other uremic toxins, routine kidney-related blood tests (creatinine, urea, uric acid), electrolytes, vitamin D metabolites, inflammatory markers, lipid markers, FGF23, short-chain fatty acids, sKlotho, and the effect of patient serum on cytokine production in a standard immune cell line. Stool analyses in a subgroup will examine shifts in bacterial groups and metabolic networks. How the intervention is delivered and monitored Foods are prepared in a certified bakery and coded so neither participants nor study staff know who receives pea fiber or placebo. To improve adherence, participants choose from a variety of pre-portioned baked items and are advised to spread intake across the day. Unused portions are returned and logged. Dietary recalls and symptom questionnaires are collected to monitor changes in overall diet, appetite and gastrointestinal side effects. Blood draws are timed before dialysis after the long interdialytic interval to standardize measurements. Potential impact and limitations If fermentable inner pea fibers lower Indoxylsulfate and related toxins, this would support a simple, food-based strategy to reduce toxin burden and possibly cardiovascular risk in dialysis patients. However, previous studies show mixed results depending on the type of fiber used: fermentable fibers (like amylose-rich starch or inulin) have produced beneficial changes in some trials, while non-fermentable fibers did not. Since evidence high-quality randomized trials in dialysis patients is still limited there is the need for this study.