Clinical Research Directory

Prospective, Multicentre, Randomized, Controlled, Cross-over Study on the Safety and Performance of the Biologic Fusion Option of DialogiQ Compared to Haemodialysis Without Biologic Fusion in Hypotension Prone Patients on Maintenance Haemodialysis

The goal of this prospective, randomized, controlled, cross-over, multicentric study is to demonstrate the safety of bioLogic Fusion in patients on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes. The main question it aims to answer is: • Which is the number and percentage of individual sessions with reached prescribed post-dialysis body weight in the prescribed treatment time in each single session in hypotensive-prone patients on high-flux haemodialysis or hemodiafiltration within each patient with treatments performed with DialogiQ with (treatment A) or without (treatment B) the bioLogic Fusion option activated? Participants will in addition to their routine dialysis treatment undergo 2 physical examinations and regularly answer questionnaires. A crossover design is used to compare treatments with or without the BioLogic Fusion function activated.

EFFECTS OF HORTICULTURAL THERAPY ON ACUTE STRESS AND SALIVARY CORTISOL LEVELS IN HEMODIALYSIS PATIENTS

The purpose of this study is to evaluate the acute psychological and physiological effects of a single-session structured horticultural therapy program on patients undergoing routine hemodialysis. The study is designed as a two-arm, parallel, pretest-posttest randomized controlled trial conducted at Bingöl State Hospital. Participants are randomized (1:1) to either an experimental group receiving a 45-60 minute individual horticultural therapy session (e.g., planting and caring for Tagetes erecta, Celosia cristata, and Petunia grandiflora) or a control group maintaining standard waiting conditions for the same duration during non-dialysis days. Primary outcomes evaluate acute changes in state anxiety (measured via STAI-1) and physiological stress response (measured via salivary cortisol concentration) before and immediately after the intervention.

Machine Learning and Artificial Intelligence Algorithms to Optimize the Performance and Delivery of Acute Dialysis

SMART DIALYSIS - Scaling Machine Learning and Artificial Intelligence AlgoRithms to OpTimize the Performance and Delivery of Acute DIALYSIS. Hypothesis: Can the investigators develop and implement Machine Learning and Artificial Intelligence Algorithms into Clinical Information Systems to Optimize the Prescription, Delivery, and Performance of Acute Dialysis? Objective(s): 1. Identify variables surrounding identified Key Performance Indicators that may be used by Machine Learning and Artificial Intelligence algorithms to optimize the prescription and performance of acute dialysis. 2. Develop Machine Learning and Artificial Intelligence algorithms to help guide the prescription and delivery of acute dialysis in the development of Clinical Decision Support tools and Best Practice Advisories and create a ML/AI Augmented SMART DIALYSIS Digital Dashboard. 3. Implement and evaluate the performance of the developed Machine Learning and Artificial Intelligence algorithms on patient-centered and health economic outcomes. 4. Validate and benchmark the performance of the evaluated Machine Learning and Artificial Intelligence algorithms across multiple jurisdictions.

Insights Into the Continuous Renal Replacement Therapy to Critical Ill Patients

This is a multinational, prospective, observational study designed to characterize patient demographics, prescription parameters, and process measures of continuous renal replacement therapy (CRRT) in intensive care units (ICUs) worldwide. The study aims to examine similarities and differences in CRRT practices and outcomes among critically ill adult patients across a global network of medical centers. The goal is to develop a large, comprehensive repository of data on CRRT practices and outcomes. This repository will enable characterization of variation in standard CRRT practices across medical centers. Natural variability in practice patterns-both between and within centers-will provide an opportunity to compare outcomes associated with different approaches and to generate high-quality preliminary data to inform future interventional trials. Primary Objective \- To describe global patient characteristics, CRRT modalities, and clinical outcomes among patients receiving CRRT. Secondary Objectives * To compare clinical outcomes across geographic regions and CRRT modalities. * To identify patient-level and practice-level predictors of outcomes. * To assess the impact of comorbid conditions (e.g., diabetes mellitus) on CRRT outcomes. Exploratory Objectives * To evaluate long-term renal outcomes and patient-reported quality of life. * To explore health economics and resource utilization related to CRRT. Study Population All patients receiving CRRT as part of routine clinical care in the ICU at participating centers will be eligible for inclusion. Data Collection The study will support an epidemiological assessment of patients undergoing CRRT, including, but not limited to, demographics, underlying disease states, severity of illness, physiological support, indications for CRRT, and clinical outcomes. Outcomes of interest include ICU and hospital mortality, ICU and hospital length of stay, and renal recovery.

Oral Versus Intravenous Vitamin B12 Replacement in Hemodialysis Patients

The goal of this clinical trial is to learn whether intravenous (IV) vitamin B12 works better than oral vitamin B12 to correct vitamin B12 deficiency in adults on maintenance hemodialysis. The main questions it aims to answer are: Does IV vitamin B12 raise blood B12 levels more than oral vitamin B12 over four weeks? Does IV vitamin B12 lead to more patients reaching a normal blood B12 level than oral vitamin B12? Do the two routes differ in their effect on blood counts and nerve-related symptoms such as numbness and tingling? Participants will: Receive either an IV injection of vitamin B12 once a week after their dialysis session, or oral vitamin B12 tablets three times a day, for four weeks Have blood tests for vitamin B12 level and blood count at the start of the study and again at week 5 Be checked for nerve-related symptoms such as numbness and tingling at the start of the study and again at week 5 Researchers will compare IV vitamin B12 to oral vitamin B12 to see which route works better at correcting B12 deficiency in hemodialysis patients.

Intradialytic Versus Home-Based Exercise in Female Hemodialysis Patients

This randomized controlled trial compared intradialytic exercise with home-based exercise in married female patients receiving maintenance hemodialysis. Ninety participants were randomly assigned in equal numbers to an intradialytic exercise group, a home-based exercise group, or a control group. Both exercise programs continued for 12 weeks. The study evaluated whether exercise performed during dialysis or at home could improve quality of life, self-esteem, sexual function, and selected clinical and laboratory outcomes. Quality of life was assessed using the 36-Item Short Form Survey, self-esteem using the Rosenberg Self-Esteem Scale, and sexual function using the Female Sexual Function Index. Laboratory assessments included calcium, phosphorus, intact parathyroid hormone, albumin, C-reactive protein, hemoglobin, sodium, and potassium.

Effect of Intradialytic Exercise on Left Ventricular Diastolic Function in Hemodialysis Patients

Introduction: Cardiovascular disease is the leading cause of morbidity and mortality in patients undergoing hemodialysis, largely due to structural cardiac changes associated with left ventricular diastolic dysfunction. In addition, this population has a high prevalence of sedentary behavior, which has been associated with increased mortality. Recent studies in patients with chronic kidney disease have shown that structured exercise interventions improve several parameters related to cardiovascular health. Objectives: To evaluate the effect of implementing systematic intradialytic exercise on left ventricular diastolic function. Materials and Methods: This will be a quasi-experimental before-and-after study conducted in two phases. During the first phase (control), prevalent hemodialysis patients will receive standard treatment for 16 weeks. Transthoracic echocardiography will be performed at baseline and repeated at the end of this phase to assess left ventricular diastolic function parameters. During the second phase (intradialytic exercise), participants will undergo a 16-week supervised and prescribed intradialytic aerobic exercise program consisting of intradialytic cycling. Exercise intensity will be individualized according to cardiopulmonary exercise testing (CPET), which will be performed at the beginning and end of this phase. A final echocardiogram will be obtained at the end of the intervention phase. In addition, a 6-minute walk test and a validated physical activity questionnaire will be administered monthly throughout both phases of the study.

A Communication Tool to Assist Older Adults Facing Dialysis Choices

The purpose of this study is to test the effect of the "Best Case/Worse Case" (BC/WC) communication tool on receipt of palliative care and intensity of treatment at the end of life, quality of life, and quality of communication for older patients with end-stage renal disease (ESRD) receiving outpatient care at ten nephrology clinics. The intervention was developed and tested with acute care surgical patients at the University of Wisconsin (UW) and is now being testing to see if the intervention will work in a different setting. The intervention will be tested with 320 older adults who have end-stage renal disease (ESRD) and are receiving care from a nephrologist enrolled in the study. Randomly assigned nephrologists within each site will receive the intervention (training to use the BC/WC tool) or to be in the waitlist control, meaning that they will not be offered BC/WC training until the end of the study, when all participants have been enrolled. Participants will be on follow up with surveys and chart review for up to two years after study enrollment. Caregivers will also be invited to participate and complete surveys.

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.

Improving Continuous Renal Replacement Therapy Outcomes in Neonates and Infants Through Interdisciplinary Collaboration

To date, little knowledge exists related to the use of hemodialysis (HD) in infants and has been limited to mainly single center studies. The CARPEDIEM (CArdio-Renal PEdiatric Dialysis Emergency Machine) device, which can be used to provide hemodialysis in infants, has been launched in the United States. This study/registry is designed to obtain data on critically ill infants who require HD using the CARPEDIEM device to understand the indications for initiation, best practice in prescribing and performing treatment, expected treatment course, and outcomes of a dedicated infant continuous renal replacement therapy (CRRT) machine.

Levocarnitine for Reducing ESA Requirements in Hemodialysis Patients With Renal Anemia

Renal anemia is common in people receiving long-term hemodialysis and is usually treated with erythropoiesis-stimulating agents (ESAs). Some patients respond poorly and require high ESA doses, which increases treatment burden, cost, and potential side effects. Carnitine deficiency is frequent in hemodialysis because carnitine is lost during dialysis and its synthesis is reduced. Levocarnitine may improve red blood cell function and reduce the dose of ESA needed to maintain hemoglobin. This single-center, randomized controlled trial will test whether adding intravenous levocarnitine to standard care reduces ESA requirements in adults on maintenance hemodialysis who have renal anemia. Ninety-four participants (age 20-60 years) on thrice-weekly hemodialysis for ≥6 months and with hemoglobin \<10 g/dL will be randomly assigned (1:1) to: Intervention: Levocarnitine 1,000 mg IV three times per week, administered after each dialysis session, plus usual anemia care including ESA per unit protocol. Control: Usual anemia care including ESA per unit protocol without levocarnitine. Participants will be followed for 6 months. Hemoglobin, hematocrit, ESA dose, and the erythropoietin responsiveness index (ERI = monthly ESA dose ÷ \[dry weight × average hemoglobin\]) will be recorded monthly. The primary outcome is the ESA dose (units/week) at month 6. Secondary outcomes include ERI and monthly changes in hemoglobin and hematocrit, along with routine safety monitoring. If levocarnitine lowers ESA needs, the findings may offer a cost-effective strategy to optimize anemia management in hemodialysis patients.

Educational Intervention and Adherence

quasi-experimental, parallel study, with the objective of evaluating the effectiveness of an educational nursing intervention supported by ICTs, for the improvement of therapeutic adherence in people undergoing hemodialysis treatment in a renal unit in Barranquilla (Colombia)

Impact of Hospital Pharmacist Intervention on Medication Management in Dialysis Patients

The goal of this clinical trial is to learn if an intervention of a hospital pharmacist could help, dialysis patients managed his treatment. In a first time, the health literacy level will be assed. The main questions it aims to answer are: What is the impact of the clinical pharmacist intervention on the understanding level and management level of his treatment by the patient? Does the intervention of the pharmacist has an effect on the biologicals parameters of the patient? Researchers will compare a group with a pharmacist intervention VS a group without pharmacist intervention for dialysis patients.

The Effect of Active Exercise on Maintenance Haemodialysis Patients

The goal of this clinical trial is to discuss the effects of physical activity on nutrition, inflammation, muscle metabolism, and the occurrence of cardiovascular and cerebrovascular events in patients with maintenance haemodialysis. The main question it aims to answer is: can exercise improve nutritional and inflammatory status, enhance muscle strength, and reduce the incidence of cardiovascular and cerebrovascular events in patients with maintenance haemodialysis. Researchers will compared active exercise group to conventional treatment group to see the impact of exercise on maintenance haemodialysis patients. Participants will: Choose low-intensity aerobic exercise workouts such as walking (no less than 8,000 steps per day) or jogging, swimming, Tai Chi, etc., according to their individual conditions, for no less than 30 minutes at a time, at least 3 times per week, and the intensity of the exercise should be based on an RPE score of 12 to 16.

Toxicokinetics of Protein-bound Uremic Toxins in ESRD Patients

Protein-bound uremic toxins (PBUTs) are important uremic toxins, represented by indoxyl sulfate (IS), derived from the fermentation of dietary proteins by gut bacteria. The purpose of this study was to study the changes of IS in maintenance hemodialysis patients, and to construct a metabolic kinetics model of IS clearance. The model was then used to estimate the clearance rate of indoxyl sulfate by hemoperage, and to verify the application value of the model. This study intends to collect a series of serum, dialysate and urine samples from maintenance hemodialysis patients receiving high-throughput dialysis or hemodialysis filtration, so as to clarify the variation rule of IS during various blood purification treatments. Furthermore, a three-compartment model of dialysis IS metabolism kinetics was constructed according to the IS clearance of dialysis and residual kidney, and the above model was verified internally and externally. Finally, the model's fit and predictive value were validated in a group of MHD patients treated with HP without residual kidney.