492 Clinical Trials for Various Conditions
The purpose of this research is to evaluate patient comfort and ease of an investigational device called Catheter Caps Case (C3) attached to the hemodialysis catheter over a 15-minute period. You have been asked to take part in this research because you have been identified as a dialysis patient with a hemodialysis catheter.
Scaled Insights Behavioral AI will be used to improve clinicians ability to detect and understand: The likelihood of patients with kidney failure opting for peritoneal dialysis and to select the right personalized nudge to get CKD patients to choose peritoneal dialysis Scaled Insights' can utilize the data from this study to develop individualized nudges for healthcare professionals that can be broadly deployed within a digital platform so that clinics across the English speaking world can use it as a means of supporting patients with CKD in selecting peritoneal dialysis treatment. Using Scaled Insights novel Behavioral Artificial Intelligence solution, the proposed project has two aims: 1. to identify personality attributes of patients with Chronic Kidney Disease and correlating their personality attributes with their subsequent choice of dialysis. Once correlated into personality based clusters, the AI Model will then be able will determine which personality cluster each net new patient will fall into and therefore predict their specific likelihood of opting for peritoneal dialysis or hemodialysis 2. once prediction is possible, customized nudges towards the selection of PD will be developed and tested to improve the likelihood that patients will opt for peritoneal dialysis Hypotheses: 1. Scaled Insights Behavioral AI will identify the personality characteristics of patients with Chronic Kidney Disease who are likely to opt for both peritoneal dialysis and hemodialysis (Phase 1) 2. Scaled Insights Behavioral AI will identify the nudges that are most effective in encouraging or supporting patients with Chronic Kidney Disease in choosing peritoneal dialysis over hemodialysis (Phase 2)
This is a human subject research study conducted in patients undergoing dialysis treatment with darbepoetin alfa at Intermountain Utah Dialysis and Intermountain Medical Center Dialysis Services. The purpose is to test a dose recommendation algorithm that may reduce hemoglobin variability and drug cost.
The objectives of this study are to refine the dialysis care model with key stakeholder input and conduct a pilot randomized controlled trial (RCT) to obtain evidence critical to inform a definitive RCT.
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.
The purpose of this research is to gather preliminary estimates of the impact of using Capacity Coaching as an intervention for patients receiving dialysis.
BAY1817080 is currently under clinical development to treat pain related to unexplained chronic cough or chronic cough not affected by a treatment (refractory and/or unexplained chronic cough, RUCC), or a condition where the bladder is unable to hold urine normally (overactive bladder, OAB) or a condition in which tissue similar to the tissue that normally lines the inside of the womb grows outside the womb (endometriosis). Especially in elderly patients with OAB or RUCC, renal impairment is frequent. Renal impairment which co-occurs in especially in elderly patients with OAB or RUCC is a common condition in which the kidneys are not filtering the blood as well as they should. End stage renal disease (ESRD) requiring hemodialysis is a condition in which patients kidneys are no longer able to work as they should and require treatment to filter wastes from the blood. The goal of the study is to learn more about the safety of BAY1817080, how it is tolerated and the way the body absorbs, distributes and excretes the study drug given in men and women with moderate renal impairment and with those who have end stage renal disease (ESRD) requiring dialysis compared with matched participants with normal kidney function.
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.
Home dialysis modalities, including peritoneal dialysis (PD) and home hemodialysis (HHD), represent alternatives to conventional in-center hemodialysis (HD) that for some patients may be better aligned with preferences regarding the integration of dialysis treatments into their lives. Assessment of patient experience and satisfaction with care among individuals undergoing maintenance dialysis in the United States is a national health care priority and mandated by Congress. While validated instruments (ICH CAHPS) are in use to assess patient experience with in-center HD, currently no validated instruments are available to measure patient-reported experience in home dialysis. This Home Patient Experience Survey Validation Study is an in-house research study conducted in partnership with the University of Washington.
Hemodialysis patients are at high-risk for infections, specifically Staphylococcus aureus infections. The investigators propose to 1) implement a novel intervention (nasal povidone-iodine at each hemodialysis session) to prevent S. aureus infections using a stepped-wedge cluster randomized trial, and 2) evaluate the feasibility and acceptability of this intervention. If successful, this intervention can be used among hemodialysis patients, and evaluated in other high-risk patient populations to prevent S. aureus infections.
This is a survey of dialysis patients and staff to determine both the readiness of ESRD patients to use mHealth as well as the Readiness of the dialysis center staff (healthcare technicians, nurses and administrative staff) to utilize mHealth in order to assist patients who may have barriers to do so for themselves.
Latinos with End-Stage Renal Disease (ESRD) represent 17% of the US adult ESRD community and suffer a disproportionate burden of social challenges that impacts their well-being. With support from the Amos award from the Robert Wood Johnson Foundation (RWJF), the investigators assessed the feasibility of a 1-arm intervention of a 5-visit lay Peer Navigator intervention to support Latino ESRD patients with social challenges and adherence (using motivational interviewing \& patient activation). This trial will build on the Amos work as a small Randomized Controlled Trial (RCT). The overall aims of this proposal are to: 1) engage key operational and clinical stakeholders early-on to develop a Peer Navigator-intervention; 2) conduct a pilot RCT of the peer navigator intervention versus standard care to test feasibility and acceptability; and 3) assess the efficacy of the intervention on interdialytic weight gain (primary outcome) as well as health-related quality of life, patient activation, and hemodialysis adherence (secondary outcomes).
The objective of this study is to determine the effect of music therapy during dialysis on: depression, anxiety, quality of life, blood pressure, heart rate, medication compliance, compliance with dialysis treatment, number of hospitalizations, pain level, and energy level.
Telemedicine (TM) is an innovative approach that has successfully facilitated palliative care consultations (PCC) in rural settings but not yet in dialysis. In this study, the investigators will deliver telemedicine-facilitated PCC to rural dialysis units leveraging an existing telehealth network.
The investigators propose a pilot feasibility study to determine if exercise delivered by passive electrical muscle stimulation (EMS) in patients with end stage renal disease (ESRD) on hemodialysis improves physical fitness and insulin resistance, outcome markers associated with morbidity and mortality in this population.
Numerous catheter designs have been studied to increase efficacy and minimize complications of catheter hemodialysis. Major complications of catheters include thrombosis, central venous stenosis, infection, and dialysis inadequacy. Thrombosis must be avoided if possible because using too many catheters may exhaust all of the catheter insertion sites on the body, as well as increase the risk of infection. This prospective study compares the complications and general outcomes of patients who receive hemodialysis using the mainstream Palindrome catheter versus the newer BioFlo DuraMax catheter. This study will examine outcomes of patients who receive hemodialysis using either the Palindrome catheter or the BioFlo catheter. Patients will be observed and outcomes will be recorded for three to six months. Outcomes will be analyzed and compared to draw conclusions on which catheter produces less catheter thrombosis.
This will be a prospective observational study of Acthar Gel in Non-Diabetic Hemodialysis \[NDHD\] patients receiving dialysis for ≤ 2 years. The project will aimed at providing proof-of-concept data that 80 U two times \[2x\] week Acthar for 6 months is a safe and effective therapy for NDHD. Effectiveness of lower dose 40 U 2X week will also be determined. Therefore the study will be a repeated measures design (Time x condition) comparison of improvement in renal function, nutritional status, quality of life and physical performance resulting from Acthar therapy.
Chronic Kidney Disease Stage 5 (CKD5) patients receiving maintenance hemodialysis are at an increased risk for developing bloodstream infections. Vancomycin is traditionally used as first-line therapy for treating these infections, but the emergence of less-susceptible bacterial strains necessitates the consideration of alternative antibiotic therapy. Telavancin is a new antibiotic that has broad-spectrum antimicrobial activity against gram-positive bacteria, including vancomycin-intermediate staphylococcus aureus. While dosing recommendations for telavancin are available for patients with normal kidney function, there are no published recommendations for CKD5 patients receiving hemodialysis. A pharmacokinetic study is needed to characterize the pharmacokinetic parameters of telavancin in these patients to determine the extent of drug removal by hemodialysis and to establish dosing recommendations for CKD5 patients on maintenance hemodialysis.
The primary objective of this study is to evaluate the efficacy and safety of roxadustat compared with active control (epoetin alfa) for the maintenance treatment of anemia in participants with ESRD on dialysis.
The purpose of this study is to evaluate the efficacy and safety of roxadustat compared to epoetin alfa for the treatment of anemia in chronic kidney disease patients on dialysis.
The purpose of the study is to determine whether ASP0113 (a CMV deoxyribonucleic acid \[DNA\] vaccine) can be detected in plasma after intramuscular (IM) injections, and to determine whether CMV-seropositive healthy volunteers, CMV-seronegative healthy volunteers, CMV-seronegative dialysis patients mount an immune response to the CMV proteins produced by the vaccine after repeated ASP0113 IM injection.
Cardiovascular disease is the primary cause of death in patients with end stage renal disease (ESRD). New research suggests that the high risk of death may be partly due to high levels of fibrosis and a loss of small blood vessels in the heart of patients with dialysis-dependent ESRD. This study is designed to compare the effects of two different drugs, spironolactone and L-arginine, with placebo on structure and function of the heart in individuals with dialysis-dependent ESRD.
The purpose of this study is to understand the effects of a dialysis center switching its dialysis patients from using Epoetin alfa to peginesatide injection on hemoglobin levels and other parameters.
A specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been generally called "Enteric DialysisTM". However, it is also referred to as enteric toxin reduction technology. Our hypothesis is to assess the potential benefits in devising a bowel-based probiotic formulation (Kibow® Biotics/RenadylTM) as a dietary supplement product for patients undergoing dialysis along with standardized care of treatment.
A specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been generally called "Enteric DialysisTM". However, it is also referred to as enteric toxin reduction technology. Our hypothesis is to assess the potential benefits in devising a bowel-based probiotic formulation (Kibow® Biotics/RenadylTM) as a dietary supplement product for patients undergoing dialysis along with standardized care of treatment.
Hypertension is a major cause of cardiovascular (CV) morbidity and mortality. Although studies in the general population have demonstrated a continuous reduction in CV risk with each mmHg drop in systolic blood pressure (SBP), multiple observational studies conducted in hemodialysis (HD) patients have demonstrated that patients with mild to moderate hypertension may have decreased mortality compared to those with normal blood pressure (BP). The investigators recently reported that among HD patients, those with routine pre-dialysis BP values that met the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines (\<140/90 mm Hg) had increased mortality compared to patients with mild to moderate hypertension. However, these observational studies included untreated patients in whom low or normal BP may reflect significant cardiac disease or other comorbid conditions. In the setting of reduced vascular compliance and impaired autoregulation, aggressive BP lowering may decrease coronary or cerebral perfusion. Thus, it is unclear if aggressive BP lowering will be harmful or beneficial. A well-designed randomized control trial (RCT) is needed to answer this important question. Prior to conducting a full-scale RCT it is prudent to conduct a pilot study to assess feasibility and inform the design of the former. The investigators propose to conduct a pilot RCT in a prevalent cohort of HD patients to assess the safety and feasibility of treating patients to a low (110-140 mmHg)and standard (155-165) mm Hg pre-dialysis BP target.
The purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with end-stage renal disease who recently started dialysis.
This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.
Currently, decisions regarding volume management for dialysis sessions in the ICU are made in large part on the nephrologists'/intensivists' overall gestalt. This gestalt is based upon a combination of commonly used measures of circulatory function, the physical exam, fluid balance, estimates of dialysis dry weight, and monitoring changes in relative blood volume status using devices such as the Crit-Line™ III, and central venous pressures. However, these tools perform poorly in predicting the circulatory system's overall response to dialysis. Consequently, episodes of dangerously low blood pressure are still frequently encountered. Better techniques to predict the circulatory system's response to dialysis are much needed. The intent of this study is to test newer metrics of circulatory system function for their ability to predict low blood pressure episodes during dialysis. This is important because it may enable the design of newer treatment strategies created to prevent low blood pressure episodes during dialysis and improve patient outcomes. The investigators overall hypothesis is that newer measures of vascular volume and dynamic indices of fluid responsiveness, previously found to better reflect cardiac preload state than currently used parameters, will better predict low blood pressure episodes during dialysis than current methods.
Patients with kidney failure on hemodialysis have an extremely high rate of cardiovascular disease including atherosclerotic cardiovascular disease. This, at least in part, is due to the chronic inflammatory status usually seen in these patients. Here we try to see if treatment with extended release nicotinic acid (Niaspan) can reduce their overall inflammatory burden (in general) and the atherosclerotic plaque inflammation (in particular).