Clinical Research Directory

Group Exercise Program Supported By Audiovisual Media During Hemodialysis

People with chronic kidney disease (CKD) undergoing hemodialysis (HD) experience muscular complications, such as sarcopenia, which worsen their functional capacity and increase mortality. Exercise programs during HD are an effective strategy to combat sedentary behavior, and implementing them through innovative technologies could facilitate their adoption in clinics, benefiting more patients. Therefore, the study's objectives are to assess the feasibility and safety of a group exercise program supported by audiovisual media conducted during HD sessions. Additionally, it will analyze factors influencing adherence, identify potential causes for interruptions or failure to perform the prescribed exercise, and evaluate the risk and prevalence of sarcopenia, its association with low muscle strength, poor muscle quality, and physical inactivity.

Music Therapy Applied During Hemodialysis

Many symptoms are encountered during the hemodialysis treatment process, and fatigue and insomnia are two of the most common symptoms. The management of these symptoms, which negatively affect the quality of life and mental well-being of individuals, is very important. It is known that the effects of pharmacological treatments are limited in the management of symptoms encountered during the HD treatment process, and the tendency towards non-pharmacological methods in symptom management is increasing. This study will be conducted to determine the effects of music therapy to be applied to individuals receiving HD treatment on fatigue, sleep quality and mental well-being. This randomized controlled experimental study will be conducted with 60 individuals receiving treatment in the hemodialysis clinic of a public hospital. Individuals will receive 30 minutes of music therapy after the 2nd hour of each hemodialysis session for 4 weeks. Research data will be collected using the Introductory Information Form, Chalder Fatigue Scale, Pittsburgh Sleep Quality Scale and Warwick-Edinburgh Mental Well-Being Scale. This study is important because it is the first study to evaluate the effects of music therapy on fatigue, sleep quality and mental well-being of individuals receiving HD treatment. It is thought that music therapy applied to individuals receiving HD treatment will contribute to the literature on evidence.

Electrical Muscle Stimulation Versus Resistive Training On Physical Measures, And Fatigue In Hemodialysis Patients

The purpose of this randomized controlled trial is to compare the effects of intradialytic neuromuscular electrical stimulation (NMES) and intradialytic resistance exercise with usual care on physical function, dialysis adequacy, and fatigue in patients receiving maintenance hemodialysis. The study aims to evaluate whether these intradialytic rehabilitation interventions provide additional benefits compared with usual dialysis care.

Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD

The purpose of this study is to find out if empagliflozin, a new diabetic medication that has been shown to be very effective in lowering the risk of heart failure, is safe and tolerated in dialysis patients. In the recent years, empagliflozin has become a major tool to prevent heart failure hospitalization and to reduce the risk for cardiovascular death in diabetic and non-diabetic patients. Although patients with severe chronic kidney disease and ESKD have very high risk of heart failure and cardiovascular death, they have been excluded from all of the previous studies. If this medication is found to be well tolerated and safe in dialysis patients through this study, future clinical studies can evaluate if this medication can also reduce the risk of heart failure and cardiovascular death in dialysis patients.

Effect of Bee Venom on T Regulatory Cells and Inflammation in Hemodialysis Patients: a Prospective Study Thesis

Chronic kidney disease (CKD) has emerged asa major cause of morbidity and mortality world-wide. Advanced CKD results in accelerated cardiovascular disease, cachexia,anemia, andnumerous other complicationswhich impair thequalityof life and shorten the life span in this population Our study aims to investigate the effect of Bee venom on T Regulatory Cells and inflammation in hemodialysis patients. This study will be carried out on (60) hemodialysis patients attending Urology and Nephrology center (Mansoura university). A prospective randomized control study. Patients will be devided in to two groups A. study group (20 patients) will receive bee venom. B. control group (40 patients): will not receive bee venom. All patients will be maintained on their regular medications eg: erythropoietin, iron, multivitamins, antihypertensive agents, and phosphate binders if needed.

Cycling During Dialysis: A Feasibility and Safety Study

People who receive hemodialysis sit for about 4 hours, three times a week, and often feel tired and weak. Exercise can help, but many patients find it hard to exercise on their own. Cycling on a stationary bike during dialysis has been shown to be safe in other hospitals, but it is not yet offered at Sunnybrook. This study will find out if a supervised cycling program during dialysis is practical and safe at Sunnybrook Health Sciences Centre (Bayview Campus). Twelve adults who have dialysis on Mondays, Wednesdays and Fridays will cycle on a bedside exercise bike during their dialysis sessions, three times a week for 3 months. Trained nurses and a physiotherapist will set up the bike and watch every session, including checking heart rate, blood pressure and oxygen levels. We will look at how many patients join and stay in the study, how many cycling sessions they complete, and whether any safety problems happen. We will also look at changes in tiredness, walking ability, quality of life, and how well dialysis cleans the blood. At the end, patients and nurses will give feedback on the program. The results will help decide if cycling can be added to regular dialysis care and will help plan a larger study.

Low-Dose Spironolactone in Hemodialysis Patients With Resistant Hypertension

Many patients on hemodialysis have high blood pressure that does not respond to three or more drugs (resistant hypertension). This pilot study gave a low dose of spironolactone (12.5 mg once daily) for 6 weeks to adults on hemodialysis with resistant hypertension. The study measured changes in blood pressure, heart rate variability, markers of inflammation (interleukin-6 and high-sensitivity C-reactive protein), a marker of cardiac stress (NT-proBNP), and serum potassium.

Impact of Telepharmacy on Hemodialysis Outcomes

This study looked at whether regular follow-up by pharmacists through phone calls (telepharmacy) can help improve the treatment of anaemia in patients undergoing haemodialysis. Anaemia is very common in patients with kidney disease and can cause fatigue, weakness, and an increased risk of heart problems. It is usually treated with medications such as erythropoietin (EPO), but managing the correct dose and ensuring patients follow treatment can be challenging. In this study, patients were divided into two groups. One group received standard care, while the other group received additional support from pharmacists through regular phone calls. During these calls, pharmacists helped patients understand their medications, encouraged adherence, monitored symptoms, and worked with doctors to adjust treatment when needed.

This Study Evaluates the Impact of the Sodium Management Tool (SMT) on Hemodialysis Patient Outcomes Compared to Standard Care

Title of the Study: Sodium Management Tool in Hemodialysis Patients Brief Summary: The goal of this clinical trial is to learn whether the Sodium Management Tool (SMT) can improve patients clnical outcomes. The main questions this study aims to answer are: Does the SMT help reduce weight gain between dialysis sessions? Does the SMT improve dialysis tolerance by reducing symptoms like low blood pressure and muscle cramps? Researchers will compare standard dialysis to dialysis using the SMT to see if clinical outcomes are better in dialysis that use the SMT. Participants will: Receive dialysis three times per week with either standard dialysis or SMT-activated dialysis Switch between standard dialysis and SMT-activated dialysis after 4 weeks Have their blood pressure, sodium levels, and symptoms monitored during treatment Report their symptoms and thirst levels in a questionnaire Some participants may continue for an additional 4 weeks with a personalized SMT setting based on their symptoms and weight changes. This study will help determine whether the SMT can improve sodium balance and make dialysis more comfortable for patients.

HD Patients' Depression and Happiness

The aim of the study is to verify the mediating effect of life of meaning and post-traumatic growth in spirituality and psychological well-being (happiness, depression).

Egg Albumin and Agave Fructans With Exercise in Hemodialysis

Patients receiving maintenance hemodialysis frequently develop loss of muscle mass, reduced physical function, and chronic inflammation. This randomized controlled trial will evaluate whether oral supplementation with egg albumin and agave fructans combined with a structured functional exercise program improves muscle mass, physical function, muscle strength, inflammatory status, phase angle, and quality of life compared with nutritional supplementation alone. A total of 66 adult participants receiving maintenance hemodialysis at Centenario Hospital Miguel Hidalgo will be randomly assigned to one of the two intervention groups and followed for 6 months.

Virtual Reality Versus Intradialytic Neuromuscular Electrical Stimulation on Renin Hormone in Chronic Kidney Patients

Worldwide accelerated advances in physical rehabilitation of chronic kidney disease; particularly whom undergoing hemodialysis. Multimodal therapeutic approaches may maximize their recovery through preliminary evidence indicating both intradialytic neuromuscular electrical stimulation or Virtual reality-based rehabilitation (VRBR) is a relatively new method that might make it easier to simulate doing functional tasks than conventional rehabilitation.

Determination of Optimal Exercise Duration Using Intradialytic Exercises on Dialysis Adequacy, Fatigue, Depression, VO2 Max, Muscle Strength, Physical Functioning, and Quality of Life in Patients Undergoing Hemodialysis

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.

A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease

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.

A Community Health Worker Service to Address Acute Care Utilization Among Young and Middle-Aged Men and Women Receiving Dialysis in High-Poverty Communities

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.

Pre-Cannulation Ultrasound Vascular Mapping Combined With Handgrip Exercise and Local Cryotherapy in Hemodialysis Patients With Difficult Cannulation

This pilot randomized controlled trial evaluated a multicomponent intervention for adult maintenance hemodialysis patients with difficult vascular access cannulation. Participants were randomly assigned to an intervention group or a usual-care control group. The intervention included pre-cannulation ultrasound vascular mapping, handgrip exercise, and local cryotherapy before vascular access cannulation. The study assessed visual analog scale pain, first-attempt cannulation success, perceived pain, anxiety, comfort, and overall care satisfaction. Participants in the intervention group also evaluated the acceptability of the intervention.

Modulation of Gut Microbiota Composition and Gut Permeability Profiles by Multispecies Synbiotic Supplementation in Hemodialysis Patients

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.

DIALysis With EXpanded Solute Removal

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).

Influencing Factors of Cerebrovascular Disease and Cognition in Hemodialysis Patients

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

DialysisBot: AI Chatbot for Hemodialysis Self-Management

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.

Respiratory Muscle Training and Quality of Life in Hemodialysis Patients

This study investigates the effect of breath booster training on respiratory muscle strength and quality of life in patients undergoing hemodialysis. It aims to determine whether targeted respiratory training can improve pulmonary function, enhance physical performance, and positively impact overall well-being in this population.

Analysis of the Influence of Dialysis Fluid Composition on Vascular Calcification in Patients With Chronic Kidney Disease Undergoing Hemodialysis

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

Trial to Evaluate and Assess the Effect of Comprehensive Pre-ESKD Education on Home Dialysis Use in Veterans

This study is intended to correct an important systemic deficit in the care of chronic kidney disease (CKD), VHA's fourth most common healthcare condition with high mortality and healthcare burden. Currently, many Veterans with CKD have poor awareness of their condition. This leads to suboptimal care. The investigators anticipate that the proposed comprehensive pre-end stage renal disease (ESRD) education (CPE) will enhance Veterans' CKD knowledge and their confidence in making an informed selection of an appropriate dialysis modality, and lead to an increase in the use of home dialysis (HoD) - an evidence-based, yet underutilized dialysis modality. Further, this study will allow us to examine whether such Veteran-informed dialysis choice can improve Veteran and health services outcomes. If successful, this study may deliver a ready to roll-out strategy to meet the CKD care needs of the Veterans and reduce VHA healthcare costs.

Aerobic Exercises and Hemodialysis Patients

Patients undergoing hemodialysis (HD) frequently exhibit elevated serum uric acid (SUA) levels, which are associated with cardiovascular risks, joint issues, and diminished quality of life (QoL). Aerobic exercise has been shown to improve cardiovascular health and reduce SUA levels in various populations, suggesting potential benefits for HD patients. Objective: This study aimed to investigate the impact of aerobic exercise on serum uric acid (SUA) levels, functional capacity, and quality of life (QoL) in patients undergoing hemodialysis (HD). Methods: This randomized controlled trial will recruit 32 participants, aged 40-60, undergoing HD. The intervention group (Group A) will participate in a structured 6-week aerobic exercise program, while the control group (Group B) will receive only conventional physical therapy. Pre- and post-intervention assessments included SUA levels, the Six-Minute Walk Test (6MWT), and the Kidney Disease Quality of Life Short Form (KDQOL-SF™)