Clinical Research Directory

Effect of Pecha Kucha Education on Fluid and Diet Adherence in Hemodialysis Patients

This randomized controlled trial aims to evaluate the effect of education based on the Pecha Kucha presentation technique on fluid and dietary adherence in patients undergoing hemodialysis. Patients receiving hemodialysis often experience difficulties in adhering to fluid and dietary restrictions, which may lead to adverse clinical outcomes. The Pecha Kucha technique is a structured, visually supported presentation format designed to improve understanding and retention of information. In this study, patients in the intervention group will receive education using the Pecha Kucha method, while the control group will receive standard education routinely provided in the dialysis unit. The study will assess whether this innovative educational approach improves adherence to treatment and clinical parameters. The findings are expected to contribute to improving patient education strategies in hemodialysis care.

The Effect of Progressive Muscle Relaxation Exercises on Depression and Fatigue in Patients Receiving Hemodialysis Treatment: A Randomized Controlled Trial

This study aims to evaluate the effects of progressive muscle relaxation exercises on depression and fatigue levels in patients undergoing hemodialysis treatment. Progressive muscle relaxation is applied as an individualized non-pharmacological intervention, and its potential contribution to psychological well-being is investigated. The study seeks to determine whether regular relaxation exercises can reduce depressive symptoms, alleviate fatigue, and improve overall emotional well-being in hemodialysis patients. Findings from this research are expected to provide evidence for the use of relaxation-based interventions as supportive care methods in the management of psychological symptoms associated with chronic kidney disease and hemodialysis.

Preoperative Hemodialysis Timing in Patients With End-Stage Kidney Disease: The POD-ESKD Pilot Trial

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.

Expanded Hemodialysis Versus High-Volume Online Hemodiafiltration for Uremic Toxin Removal

People with advanced kidney disease need dialysis to remove waste products from the blood. Some of these waste products, called uremic toxins, are small, while others are medium-sized and more difficult to remove. Poor removal of these toxins may contribute to symptoms and long-term complications in patients on dialysis. Two dialysis techniques are commonly used to improve toxin removal beyond standard hemodialysis: expanded hemodialysis (HDx) using medium cut-off membranes, and high-volume online hemodiafiltration (HV-OL-HDF). Although both techniques are effective, the best way to prescribe expanded hemodialysis-particularly the ideal treatment time-has not been clearly defined. The purpose of this study is to compare how well different treatment times of expanded hemodialysis remove small and medium-sized uremic toxins, and to compare these results with high-volume online hemodiafiltration. Toxin removal will be evaluated using a combined measurement called the Global Removal Score, which summarizes the removal of several important waste substances. This is a single-center, randomized, open-label, crossover study. Adults receiving maintenance hemodialysis will receive three different expanded hemodialysis sessions with different treatment durations (180, 210, and 240 minutes), followed by one session of high-volume online hemodiafiltration. Blood samples will be taken before and after each dialysis session to measure toxin levels. The results of this study may help determine whether expanded hemodialysis with shorter or standard treatment times can achieve toxin removal similar to high-volume hemodiafiltration, which could support more personalized and practical dialysis prescriptions.

Examine the Epidemiology and Outcomes of Transitions From PD-to-HD in Canada

Transitions from peritoneal dialysis to hemodialysis are common during kidney replacement therapy and may be associated with adverse outcomes. However, the incidence, predictors, and outcomes of PD-to-HD transitions at a national level remain incompletely characterized. This study will use Canadian dialysis and hospitalization databases to examine the epidemiology and outcomes of PD-to-HD transitions among adults initiating dialysis in Canada. The study will evaluate transition incidence, predictors, and post-transition outcomes including mortality, transplantation, modality changes, and hospitalizations.

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.

Copeptin Concentration Measured in Plasma Samples and Intradialytic Blood Pressure Variation

Vasopressin is a key regulator of water and vascular homeostasis, acting through V2 receptors to control renal water reabsorption and through V1a receptors to influence vascular tone. Copeptin, a stable surrogate marker of vasopressin release, provides a reliable measure of vasopressin activity. In hemodialysis, where ultrafiltration and osmotic shifts challenge fluid balance, the contribution of vasopressin to intradialytic blood pressure regulation remains uncertain. Elevated copeptin levels in dialysis patients have been associated with interdialytic weight gain and adverse cardiovascular outcomes. This study (CODIALHYP) tests the hypothesis that vasopressin activity, assessed through copeptin levels, is associated with intradialytic hypertension. The primary objective is to evaluate the relationship between copeptin concentrations and blood pressure changes during hemodialysis. Secondary objectives include assessing whether vasopressin's antidiuretic effect is preserved in hemodialysis patients and exploring the contribution of other hormonal pathways involved in fluid and vascular regulation.

A Survey for Patients and Caregivers Aiming to Understand and Improve the Care of Patients at High Risk of Transfer From Peritoneal Dialysis to Hemodialysis:

Home dialysis is encouraged in Canada and peritoneal dialysis is the most common home dialysis method. However, many patients discontinue peritoneal dialysis, often transferring to hemodialysis. Despite the frequency of this transition, little is known about its impact on patients. Overall, the UPLIFT-PD program aims to fill this gap by studying the transition from peritoneal dialysis to hemodialysis. The specific goal of this mixed methods sub-study is to conduct a national survey to ask patients and caregivers about priorities and preferences when they anticipate a transfer from peritoneal dialysis to hemodialysis. This survey will be co-created by patient-partners and dialysis experts. Results from this survey will then be used in other phases of UPLIFT-PD program, detailed in other registrations, which will support people facing a transition from peritoneal dialysis to hemodialysis..

Hemodiafiltration Versus Hemodialysis in Older People

This study will compare the impact of two hemodialysis techniques on fatigue and post-dialysis recovery time in patients aged 85 years and older. These two techniques are high-flux hemodialysis (HD) and hemodiafiltration (HDF). Patients will receive the treatment over two periods: if period 1 is HD then period 2 will be HDF. Every patient will be his/her own control, this is why it is called cross-over. Each period will last three months. Between the two periods, patients will receive a traditional low-flux hemodialysis. These two techniques are widely used worldwide and their side-effects are well-known and do not put the patients at risk. HDF has been shown to improve survival in patients with a mean age of 58 years. But a previous study from the investigators' group showed that HDF causes a prolonged recovery time in older patients. This randomized trial aims to elucidate this question.

The Effect of Sacubitril and Valsartan on Heart Function in Chronic Hemodialysis Patients With HFpEF

Heart failure is the most common cause of death of patients on chronic hemodialysis treatment, and to date there is no effective therapy for the treatment of this comorbidity in this group of patients. The most common form of heart failure in these groups of patients is heart failure with preserved ejection fraction (HFpEF). As a new therapy for heart failure, a new group of drugs called angiotensin receptor and neprilysin inhibitors (ARNI) has been imposed, whose representative is the drug sacubitril/valsartan. The therapy has been shown to be superior to any other therapy to date for the treatment of heart failure with reduced ejection fraction (HFrEF) and has been included in European and American guidelines for the treatment of patients with HFrEF. Since 2022, the drug has been approved in the USA for the treatment of patients with HFpEF, while in Europe it is still not approved for this indication. Currently, the drug is not approved for patients on chronic hemodialysis anywhere in the world, and its effect on this group of patients is unknown. There are very few studies examining the safety and efficacy of sacubitril/valsartan in chronic hemodialysis patients with HFpEF. Precisely because of this, the aim of this study is to determine the effectiveness of this drug in these groups of patients. I will conduct the research as a randomized controlled trial (single blind research) where the subjects will be patients on chronic hemodialysis treatment who have proven HFpEF. HFpEF is proven by the HFA-PEFF scale. The patients will be divided into two groups - the test group and the control group (30 patients in each group). The input variables will be patients on chronic hemodialysis treatment (whose hemodialysis treatment lasts at least one year); patients with heart failure with preserved ejection fraction; height; weight. Output variables will be heart ultrasound parameters and laboratory findings (NTproBNP, hs troponin, aldosterone, renin). The aim of the study is to determine the effect of sacubitril/valsartan on ultrasound parameters and on cardiovascular and other biomarkers in patients on chronic hemodialysis treatment with HFpEF.

Autogenic Relaxation and Murottal Therapy in Hemodialysis Patients

This quasi-experimental study aims to evaluate the effect of combined autogenic relaxation and Surah Ar-Rahman murottal therapy on anxiety, sleep quality, and hemodynamic parameters in hemodialysis patients. A pretest-posttest control group design will be used involving 76 participants undergoing routine hemodialysis. Participants will be assigned to an intervention group receiving structured autogenic relaxation followed by murottal therapy and a control group receiving standard care with music listening. Anxiety, sleep quality, and hemodynamic parameters will be measured at baseline and after a 6-week intervention period. The findings are expected to support the use of non-pharmacological and spiritual-based interventions in improving psychological and physiological outcomes in hemodialysis patients.

The Application of Art Therapy to Patients Undergoing Hemodialysis Treatment

Purpose of the Study: This study aims to investigate the effect of art therapy on anxiety and psychological resilience levels in Chronic kidney disease(CKD) patients undergoing hemodialysis patients. Hemodialysis patients undergo long-term treatment, often experiencing psychological issues such as anxiety and depression, which significantly reduce their quality of life. Among non-pharmacological approaches to alleviate these symptoms, art therapy has gained increasing attention. Art therapy helps patients shift their focus away from their illness, fosters self-confidence, reduces anxiety, and promotes relaxation .

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.

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.

Therapeutic Effect of Manuka Honey Oral Rinse in Periodontitis Patients Undergoing Hemodialysis

Chronic Kidney Disease (CKD) has a strong association with chronic periodontitis, an oral disease causing tooth loss linked to inflammation and malnutrition. While periodontitis affects 12.7% of the general population, its prevalence can rise to 39% in certain racial groups, and a dose-response relationship exists with CKD. End Stage Renal Disease (ESRD) patients show a prevalence of periodontitis ranging from 29% to 85.6%. Uremia, immunosuppression, and vitamin D deficiency are suggested factors in the etiology of periodontitis in CKD patients, with uremic toxins potentially altering the oral ecosystem. Periodontitis involves bacterial biofilm and Gram-negative anaerobes as primary etiological factors. The main treatment goal is to reduce periodontal pathogens and control inflammation, with non-surgical periodontal therapy (NSPT) being the standard. Although various adjuncts like antibiotics and antiseptics are suggested, recent guidelines only recommend certain locally administered agents and systemic antibiotics for specific groups due to increasing bacterial resistance. Alternative treatments like honey have gained interest, particularly Manuka honey, known for its antibacterial properties against antibiotic-resistant bacteria. This honey's effectiveness is due to its high sugar concentration, low pH, and formation of hydrogen peroxide. Manuka honey's unique component, methylglyoxal (MGO), is a potent bactericide, virucide, and fungicide, linked to its Non-Peroxide Activity (NPA) and Unique Manuka Factor (UMF) rating. MGO also has immunomodulatory effects beneficial for wound healing and tissue regeneration. Previous studies show Manuka honey as a promising adjunct in NSPT, improving outcomes significantly without adverse effects. Ongoing research aims to evaluate its effects in ESRD patients on hemodialysis, focusing on clinical attachment levels, other periodontal parameters, and FGF 21 levels in gingival crevicular fluid.

Physical Activity for Haemodialysis Patients: Evaluation of Personalised Support by an Adapted Physical Activity Teacher and an Advanced Practice Nurse

Physical activity is defined as 'any bodily movement produced by skeletal muscles that results in an energy expenditure greater than that of the resting metabolism'. Physical activity includes 'activities of daily living, physical exercise and sporting activities'. The scientific community is agreed in recognising the benefits of physical activity, both in healthy individuals and in those suffering from chronic diseases. With this in mind, the law of 2 March 2022 allows doctors to prescribe Adapted Physical Activity. In the case of chronic renal failure, there are a number of factors that can limit physical activity in haemodialysis patients, such as anaemia, nutritional status and post-dialysis fatigue. However, the risks associated with a sedentary lifestyle play a role in the development of chronic disease, in particular hypertension and diabetes. The benefits of physical activity have been widely identified in chronic renal failure, particularly in terms of cardiovascular and muscular function. More generally, physical activity has a positive impact on physical, psychological and social quality of life (increase in overall quality of life score, improved sleep, reduced pain, etc.). Physical activity should therefore be encouraged in patients with chronic renal failure, whether on dialysis or not, whatever their age. The aim of this study is to assess whether individualised support (from an advanced practice nurse and an adapted physical activity teacher) improves the practice of physical activity at home in patients who have been on haemodialysis for less than a year, and whether this improvement is sustainable over time.

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.

Studies on Adsorption International Learning Initiative Global

Use of sorption technologies in patients undergoing maintenance hemodialysis with inflammatory syndrome and clinical manifestations of uremia

The Effect of Home-Based Walking on Symptoms and Health Profile of Hemodialysis Patients

This study aims to evaluate the effect of 8 weeks of home-based moderate-speed walking on hemodialysis symptoms and health profile while patients are receiving hemodialysis treatment. Due to permanent deterioration in kidney function, patients need hemodialysis treatment, which is the most commonly used treatment method among renal replacement therapies. Hemodialysis treatment causes a series of physical and psychological problems. Problems such as hypotension, headache, nausea, muscle cramps, itching and pain are physical problems, while depression, anxiety, cognitive disorders and stress are psychological problems. In addition, it has been reported that long-term hemodialysis treatment and all the resulting problems increase the tendency to a sedentary lifestyle in this patient group, leading to a decrease in physical function and activity, and indirectly to a low quality of life and low survival rates. For this reason, hemodialysis patients have difficulty meeting their daily activities and needs, and their dependency and healthcare burden increase. Adopting a sedentary lifestyle by these patients prevents them from managing both the physical and psychological problems of hemodialysis and their conditions such as hypertension and diabetes mellitus, and causes the disease to progress. Physical exercises, which are considered among the useful therapeutic suggestions in addition to pharmacological treatments in the management of the negative situations that arise, are considered as an easy, useful and effective intervention method. Kidney Disease: Improving Global Outcomes (KDIGO) recommends 30 minutes of moderate-intensity physical exercise at least 5 days a week. Additionally, it should not be overlooked that whether patients have places to do physical activity and what their facilities are are a detail that should be questioned by health professionals. Patients without suitable accommodations should be encouraged to engage in physical activity, especially in indoor spaces like home. Home-based walking exercise is known to be easy, inexpensive, and safe, and is also advantageous when the weather is not favorable. When we examined the studies in which home-based walking exercise was performed, it was determined that its effect on functional capacity was generally investigated, but its effect on the health outcomes and symptoms of patients receiving hemodialysis treatment was not evaluated. There was no evidence that home-based walking exercise had any effect on symptoms in patients receiving HD treatment. Therefore, it was planned to conduct a study to evaluate whether home-based walking exercise has an effect on patient health outcomes.

Functional Proteomics of Uremic Retention Solutes Associated With Immunosenescence, Inflammation and Impaired Adaptive Stress Response

This is a randomized controlled crossover trial (58) in order to characterize PBL damage and death rate in hemodialysis patients treated with membranes with different permeability, including protein-leaking dialysers. The study will enroll fourty patients on regular 4-h three times per week hemodialysis (HD) of the dialysis unit of the "Fondazione IRCCS Policlinico San Matteo" (Pavia, Italy). Thirteen age and sex matched healthy individuals (Ctr) and ten CKD patients on peritoneal dialysis treatment (PD\*) will be included as healthy and CKD-matched controls, respectively. Comparison between HD and PD patients is aimed to assess the effect of biocompatibility and protein leakage during the treatments

Effect of Hand Reflexology Massage on Fatigue and Anxiety Among Patients Undergoing Hemodialysis

The goal of this clinical trial is to learn if hand reflexology massage can help reduce fatigue and anxiety in adult patients undergoing hemodialysis treatment. The main questions it aims to answer are: * What are the levels of fatigue and anxiety in hemodialysis patients? * Is hand reflexology massage more effective than usual care in reducing fatigue and anxiety after eight sessions? * Do these improvements last over time? * Does a patient's age, gender, education level, how long they've been on dialysis, or their financial status affect how much they benefit from the massage? Researchers will compare patients who receive hand reflexology massage plus standard care to those who receive only standard care to see if the massage leads to greater reductions in fatigue and anxiety. Participants will: * Be randomly assigned to one group that receives hand reflexology massage or another group that continues with routine care only * Attend 8 short sessions (about 27 minutes each) of hand reflexology massage over four weeks, given during their regular dialysis visits * Complete brief questionnaires about their fatigue and anxiety levels before the study starts, after the 4th session, and after the 8th session * Continue their normal medical treatments throughout the study This study focuses on a safe, non-drug therapy that nurses can easily provide. Hand reflexology involves gentle pressure on specific points of the hands linked to stress relief and relaxation. It is chosen because it is practical during dialysis, avoids touching swollen or sensitive feet, and respects cultural preferences. The results could help improve the comfort and well-being of hemodialysis patients in Iraq and similar healthcare settings.

Angiotensin-Neprilysin Inhibition in Hemodialysis Initiation

This randomized placebo-controlled clinical trial will evaluate the effect of sacubitril/valsartan (compared with placebo) on echocardiographic measures of hypervolemia, preservation of residual renal function, and key safety parameters in incident hemodialysis patients.

Exercise and Cardiac Stunning During HD

The purpose of this study is to determine the effect of a 12-week cycling during hemodialysis program on hemodialysis-induced myocardial stunning in adult individuals receiving hemodialysis.

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™)