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Hemodialysis Complication clinical trials

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NCT ID: NCT05410691 Completed - Clinical trials for Hemodialysis Complication

Handheld Ultrasound-guided Cannulation of Difficult Haemodialysis Arteriovenous Access by Renal Nurses

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Cannulation of complex arteriovenous fistula (AVF) or graft (AVG) is a challenge to renal nurses. Ultrasound (US) guidance on central and peripheral venous access visualisation has been widely adopted in nephrology and shown to reduce complications of vascular interventions. With broader adoption of handheld US devices in clinical services, renal nurses could acquire this point-of-care technique to increase the successful cannulation rate while facilitating confidence build-up during training and practice. We aim to evaluate the use of handheld US on difficult AVF/AVG cannulation in a hospital-based dialysis unit.

NCT ID: NCT05407207 Recruiting - Diabetes Mellitus Clinical Trials

Therapeutic Plantar Electrical Stimulation Intervention During Hemodialysis to Improve Balance and Mobility

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

A high prevalence of diabetes has been reported in Qatar with nearly 23% population suffering from the pandemic, thereby increasing the associated healthcare cost. Low compliance with exercise and physical activity in patients with diabetes increases foot risk complications, deteriorates health, and further increases economic costs. This is particularly true among patients with diabetes who are undergoing hemodialysis (HD) process. Exercise interventions have been shown to improve mobility and balance, reduce the incidence of falls, and improve peripheral blood flow, which is essential to reduce foot problems and peripheral arterial disease. However, uptake of exercise programs for individuals who are undergoing HD treatment has been limited. The three main factors limiting uptake and adherence among HD patients are time availability, post-dialysis fatigue, and transportation to exercise programs, which are usually offered in rehabilitation departments or cardiovascular centers but not in nephrology departments or in free-standing dialysis clinics. Many of these patients visit clinics 3 times a week to receive hemodialysis, providing an optimal opportunity for intervention. Thus the investigators are proposing an innovative intervention based on plantar electrical stimulation treatment during HD (3 times per week) to enhance balance and quality of life while reducing the risk of peripheral arterial diseases and diabetic foot ulcers, which are highly prevalent among people with diabetes and chronic kidney disease. This interdisciplinary study is based on preliminary studies, in which the investigators demonstrated that regular plantar electrical stimulation is an effective and practical therapy to enhance motor performance and plantar sensation in patients with diabetes. The scientific premise of the proposed intervention has been also supported by literature as well as three systematic reviews suggesting the effectiveness of electrical stimulation to reduce pain, improve balance, improve skin perfusion, and improve plantar sensation. In the context of this study, the investigators propose to bring an innovative technology based on an FDA-cleared bio-electric stimulation technology (BEST®) microcurrent platform, named Tennant Biomodulator® (Avazzia Inc., Dallas, TX, USA), which is a transcutaneous electrical nerve stimulator (TENS) and has been designed for symptomatic relief and management of chronic pain. However, the system was modified to provide electrical stimulation to the plantar area via two electrodes placed on the hind and forefoot area instead of the leg. The device has a 60-minute run cycle after which it automatically turns off. In the context of a previous study funded by QNRF, the investigators developed and tested 50 electrical stimulation units (which will be used in the context of the study), including 25 active systems and 25 placebo systems. The placebo systems are similar to active systems in the appearance and functioning of lights and indicators. However, they were programmed not to provide any electrical current. In a preliminary study, the proof of concept of this revised technology was tested in the context of enhancing balance and skin perfusion in ambulatory patients with diabetes and peripheral neuropathy. In the context of this study, the investigators plan to translate this technology for routine treatment during HD sessions for patients with diabetes who are undergoing regular HD treatment. Using a double-blinded randomized-controlled model, the investigators will validate the effectiveness of this technology to enhance balance, reduce pain, and improve skin perfusion. One hundred (n=100) HD volunteers with diabetes will be recruited and randomized to either intervention (n=50) or control (CG: n=50) group for the purpose of this study. Plantar electrical stimulation will be provided during HD sessions, 3 times per week and for 12 weeks. Outcomes will be assessed at baseline, 6 weeks, and 12 weeks to examine the effectiveness of the proposed intervention to enhance balance, improve quality of life, and improve lower extremity skin perfusion among HD patients with diabetes. This proposal is in line with Qatar National Priorities Research goals and if successful the result will open new doors to managing diabetes and kidney failure. In a setting where no therapeutic agents or interventions effectively address poor balance and loss of protective sensation among HD patients with diabetes and where affected individuals life with a heightened risk of developing a debilitating foot ulcer and quite possibly a disabling amputation, the potential impact from the plantar electrical stimulation system may offer the potential for significant clinical benefit, with very low risk, and with ease of implementation in routine care application for patients who are undergoing HD treatment.

NCT ID: NCT05398432 Completed - Clinical trials for Hemodialysis Complication

The Effect of Hemodialysis Treatment on Self-Care Power and Disease Adjustment of Patients

Start date: February 2, 2020
Phase: N/A
Study type: Interventional

The study was conducted to determine the effect of self-care supported motivational interviewing on patients receiving hemodialysis treatment on self-care power, disease compliance and metabolic variables. The study was completed with 77 patients. In the collection of data; Personal Information Form, Self-Care Strength Scale, Chronic Disease Adjustment Scale and Patient-Specific Metabolic Variables Form were used.

NCT ID: NCT05333692 Completed - Clinical trials for Hemodialysis Complication

Oral Nutritional Supplementation of Hemodialysis Patients

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

This study is aimed to demonstrate that increase in serum albumin concentration (week 8 -baseline) after test treatment (Fresubin® Protein Energy DRINK), a standard ONS, is not relevantly smaller than that after control treatment with NEPRO®.

NCT ID: NCT05297786 Recruiting - Clinical trials for Hemodialysis Complication

Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease

Hinder
Start date: July 27, 2022
Phase: Phase 2
Study type: Interventional

Bradykinin is a potent vasodilator that is formed by the activation of the kallikrein-kinin system. We and others have shown that bradykinin increased during hemodialysis; however, the role of bradykinin in dialysis-induced hypotension (DIH) has not been evaluated. Preliminary results from a pilot clinical trial showed that bradykinin B2 receptor blockade with icatibant prevents excessive blood pressure during hemodialysis. Thus, in this study, we will test the overarching hypothesis that blockade plasma kallikrein with lanadelumab would ameliorate the reduction of blood pressure during hemodialysis in patients who are prone to DIH. For this purpose, we will conduct a parallel arm, double-blind placebo-controlled trial, using lanadelumab to evaluate the occurrence of

NCT ID: NCT05273424 Enrolling by invitation - Clinical trials for Chronic Kidney Diseases

Clinical Outcomes of Hemodialysis in Brazil (COHEBRA): a Prospective Cohort Study

COHEBRA
Start date: June 1, 2017
Phase:
Study type: Observational

Introduction: Chronic kidney disease (CKD) is characterized by progressive decrease in glomerular filtration rate (GFR), eventually reaching the end-stage renal disease (ESRD) requiring renal replacement therapy (RRT). The decrease in GFR is associated with a linear increase in cardiovascular mortality. Dysfunction of the autonomic nervous system (ANS) has been well documented in patients with CKD, especially in people with ESRD. The renal ischemia causes both the excessive activation of the renin-angiotensin-aldosterone system (RAAS) by increasing renin release, as sympathetic ANS, through the afferent sympathetic nerves. The overactivated RAAS and sympathetic SNA feedback each other, which contributes to cardiovascular disease (CVD) in CKD. Despite the involvement of these systems in the pathogenesis of CVD in CKD, drugs that block the RAAS or sympathetic SNA have shown heterogeneous effects in CVD in this population. A potential explanation is the genetic heterogeneity, such as the polymorphism in the gene for angiotensin converting enzyme (ACE).In addition, the inflammatory process associated with CKD is regarded as central player in the general degenerative changes backing CKD on HD shorter survival, which in many aspects is like accelerated aging. Skeletal muscles are also affected in a pattern like aging sarcopenia, with loss of function and mass. Objectives: to evaluate the impact of ECA gene polymorphism, HRV, body composition, functional capacity, muscle strength, inflammatory factors and other potential predictors on the survival of patients with CKD treated by HD in a single center in southern Brazil. Methodology: Prospective cohort study. The sample will consist of adult patients with CKD on HD longer than 90 days. Sociodemographic and clinical data is collected from clinical records. HRV analysis is performed using a Micromed@ electrocardiogram device® with a recording of the standard deviation of all normal intervals (SDNN), square root of the mean of the squares of the differences between consecutive intervals (RMSSD), low frequency band (LF) and high frequency (HF) after a midweek HD session. The polymorphism of the ECA gene was evaluated by polymerase chain reaction method in peripheral blood DNA sample. Muscle quality and thickness has been obtained by ultrasound. Functional capacity by 6-minute walking test and muscle strength by dynamometer. The data will be analyzed using Stata 15.0 statistical package.

NCT ID: NCT05241587 Completed - Nausea Clinical Trials

Chewing Gum in Hemodialysis Patients

Start date: March 3, 2018
Phase: N/A
Study type: Interventional

This study was conducted to evaluate the effect of chewing xylitol gum on thirst, dry mouth and nausea in patients undergoing haemodialysis.Patients undergoing haemodialysis often experience thirst, dry mouth and nausea.This was a prospective, non-randomized experimental study involving a control group. The study was carried out with patients undergoing haemodialysis in a private dialysis centre in the northeast of Turkey between July and December 2018. It was completed with a total of 75 patients assigned to the gum group (n=25), mouth spray group (n=25), and control group (n=25).The patients in the gum group chewed xylitol gum for 10 minutes, five times a day for six weeks. Patients in the mouth spray group used two puffs of mouth spray three times a day. No intervention was made in the control group. Data were collected with the Patient Information Form, Charlson Comorbidity Index, Visual Analogue Scale, Rhodes Index of Nausea, Vomiting and Retching, graduated tube, and pH meter. Data were evaluated with Mann-Whitney U, Pearson Chi-square, Kruskal Wallis and Friedman tests. TREND checklist for non-randomised controlled trials was followed.

NCT ID: NCT05240573 Active, not recruiting - Clinical trials for Hemodialysis Complication

Strong Kidney Initiative Trial for Dialysis Care Quality

SKI
Start date: May 1, 2023
Phase: N/A
Study type: Interventional

Chronic kidney disease (CKD) is an important global health issue that imposes a substantial healthcare burden in both developing and developed economies. The global prevalence of CKD-related mortality was estimated from 9.6 per 100,000 in 1990 to 11.1 per 100,000 in 2010, and the global prevalence of end-stage kidney disease (ESRD) was estimated from 75.9 per 100,000 in 2005 to 100.7 per 100,000 in 2010. In Taiwan, a long-lasting epidemic of CKD has created critical economic and social challenges in its health care system. Over the past 20 years, the annual incidence and prevalence of ESRD in Taiwan have surged from 126 to 361 per million and from 382 to 2,584 per million, respectively. National Health Insurance Bureau in Taiwan has spent a huge budget to support healthcare for ESRD patients requiring maintenance dialysis therapy without observing significant improvement in ESRD prevention and management. The main challenge in effectively preventing and managing ESRD is to obtain the full-spectrum data, such as lifestyle, diet, over-the-counter medication use, Chinese herbal medication use, and the occurrence of unaware outpatient acute kidney injury, on patients with CKD. This unmeasured information regarding patient's daily life is crucial because patients spend most of their time outside the hospital, even for patients receiving hemodialysis 3-4 times per week spend only 10% of their daily life in the healthcare facility. With the digital transformation of the healthcare system and the blockchain technology brought by the advances in data storage, data transfer, data safety, and computing power, collecting and exchanging comprehensive data becomes possible. The investigators will establish a full-spectrum kidney database by re-organizing all kidney-related clinical data that were generated in China Medical University Healthcare System (CMUH) and Asia University Healthcare System (AUH), integrating data collected in the dialysis outpatient clinic at CMUH and AUH, such as gait data, grip data, and skin image, combining daily life data such as diet, exercise, and sleeping condition collected from the Strong Kidney Initiative APP (SKI APP) or wearable devices. The investigators will then use the SKI APP and blockchain technology to provide digital service to dialysis patients and to prospectively collect daily life data. The digital service would include the visualization of real-time kidney data, kidney care recommendations, and innovative artificial intelligence-based services for kidney health prediction and suggestion. This proposed clinical trial aims to evaluate the clinical effectiveness of SKI digital services regarding the outcomes of the rate of emergency department (ED) visits, inpatient admission rate, kidney function improvement, mortality, and healthcare utilization in dialysis patients in 12 months. The clinical trial will be conducted on the patients who regularly receive hemodialysis care from the CMUH and AUH Healthcare Systems. Patients assigned to the intervention arm will be provided the SKI APP and related digital services and patients assigned to the control arm will be provided the ordinary CMUH dialysis care APP. The investigators will provide an education program for the APP and monitor the utilization of APP. The investigators hypothesize that patients receiving the SKI APP will have lower ED and inpatient admission rates, better kidney function maintenance, lower mortality, and decreased healthcare utilization. The results of the SKI trial will provide solid evidence regarding the real-world effectiveness of a comprehensive intelligent kidney care digital service using blockchain technology.

NCT ID: NCT05228132 Terminated - Clinical trials for End Stage Renal Disease

The Pristine Post-Market Study

Start date: May 16, 2022
Phase: N/A
Study type: Interventional

This is a prospective, multi-center, single-arm study designed to assess the safety and performance of the Pristineā„¢ Long-Term Hemodialysis Catheter.

NCT ID: NCT05176730 Completed - Clinical trials for Chronic Kidney Diseases

Mindfulness Meditation For Hemodialysis Patients

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Objective: This study aimed to examine the effects of mindfulness meditation on trait mindfulness, perceived stress, emotion regulation, and quality of life in end-stage renal disease patients undergoing hemodialysis. Method: An experimental repeated measures design was used among a sample of 74 end-stage renal disease patients undergoing hemodialysis at a dialysis center at Jahra hospital, Kuwait. The patients were randomly assigned to the experimental (n=37) and control groups (n=37). The experimental group participated in 30-minute mindfulness meditation sessions (three sessions a week for five weeks) held during their hemodialysis sessions. The dependent variables of both groups were measured at baseline, middle of intervention, and end of intervention using the Mindful Attention Awareness Scale (MAAS), Perceived Stress Scale (PSS), Emotion Regulation Questionnaire (ERQ), and Kidney Disease Quality of Life (KDQOL-36) questionnaire.