Icodextrin Study to Test Short-Term Safety, Tolerability and Preliminary Efficacy of Sodium-Free...
Chronic Kidney FailurePatients with kidney failure rely on dialysis for sodium and fluid removal. The importance of a sodium and fluid balance in patients with kidney disease is very important. Excess volume has been consistently associated with cardiovascular morbidity and mortality. Many peritoneal dialysis (PD) patients need large volumes of dextrose or Icodextrin based solutions to achieve fluid removal. Commonly used PD solutions also have high sodium concentrations to limit sugar absorption. These PD fluids can reduce the amount of sodium removed and may eventually lead to water retention over time with possible adverse outcomes. This research study is being conducted to determine if a single eight-hour dwell of intraperitoneal sodium-free 30% Icodextrin / 10% Dextrose solution is safe, tolerable and effective in achieving sodium and volume removal in PD patients.
Renal Replacement Therapies Decision Aids
End-stage Renal DiseaseRenal Replacement Therapy2 moreDifferent renal replacement therapy methods will cause significant impacts on the physical, mental, and social for patients with end-stage renal disease. Application shared decision-making should be able to effectively assist patients in choosing suitable renal replacement therapy. Currently, most of the patient decision aid of renal replacement therapy are written health education leaflets, which have problems such as too many words, more difficult content, and inconvenience. In shared decision-making, even though different treatment options are communicated to patients, there is still a gap between "understanding" and "real experience", it will be creating uncertainty of decision, and emphasizing true situational learning strategies should be a viable auxiliary method. Therefore, this study aims to develop a web-based patient decision aid of renal replacement therapy and integrates situational learning strategies into it. First, investigators have conducted a qualitative study to explore the related experience of patients with end-stage renal disease the decision-making needs in renal replacement therapy choice, and the experience and barrier of reading paper patient decision aid. Next, based on the results of the pilot study, the modified Delphi method will be used to collect the opinions of experts, and the situational learning theory will be integrated into the patient decision aid to develop the web-based situation renal replacement therapies patient decision aid. After completion, investigators will apply quasi-experimental, a repeated measurement that will be adopted to analyze the effectiveness of web-based patient decision aid of renal replacement therapy in shared decision-making in patients with end-stage renal disease.
Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
End-Stage Kidney DiseaseThis global study will assess the effect of randomising dialysis sites to one of two default dialysate sodium concentrations in current practice, 140mmol/l and 137mmol/l, on major cardiovascular events and death in patients receiving maintenance haemodialysis.
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD...
Atherosclerotic Cardiovascular DiseaseEnd Stage Kidney DiseaseThis is a 2-part (phase 2b/3) prospective, interventional, multicenter, randomized, double blind, placebo controlled study. Part 1 (phase 2b) is a dose-finding study for CSL300 vs placebo. Part 2 (phase 3) aims to assess the efficacy of CSL300 on CV outcomes and safety in subjects with ASCVD or diabetes mellitus and evidence of systemic inflammation who are undergoing maintenance dialysis.
Increasing Live Donor Kidney Transplantation Through Video-based Education and Mobile Communication...
End-stage Renal DiseaseChronic Kidney DiseasesThe study is a- 2-arm randomized controlled trial among patients presenting for kidney transplant evaluation at a single transplant center to compare the effects of a patient-based self-learning and outreach intervention about living-donor kidney transplantation (KidneyTIME) versus usual care for living-donor kidney transplant knowledge, concerns, readiness, access behaviors, and living-donor inquiries over 12 months follow-up. Following consent and baseline assessment, participants were randomized, stratified by self-reported race, with equal allocation to 2 treatment arms: the KidneyTIME intervention and usual care.
Facilitating Communication Study
Chronic DiseaseNeoplasm Metastasis20 moreThis study is a randomized clinical trial of an intervention to improve outcomes for patients and their family by using ICU nurse facilitators to support, model, and teach communication strategies that enable patients and their families to secure care in line with patients' goals of care over an illness trajectory, beginning in the ICU and continuing to care in the community.
Physical Activity in Dialysis: Clinical and Biological Impact
Chronic Renal FailurePhysical inactivity is known to increase the risk of developing many diseases as cardiovascular diseases, diabetes, some cancers, and other chronic diseases. The impact of the inactivity is even higher in a fragile population as patients with Chronic Renal Failure (CRF) who need dialysis. This can lead to serious adverse events during the lifetime of these patients, such as arteriopathy which can result in amputation, deterioration of general condition, loss of independence and depression of wasting away. Despite the need to promote physical activity in this population of hemodialysis patients with CRF, little is known about the effects of a supervised physical activity conducted in these patients. With this study, the investigators propose to assess the effects of a physical activity program on several parameters, in hemodialysis subjects.
Continuous Glucose Monitoring in Patients With End-Stage Kidney Disease and Burnt-Out Diabetes
End Stage Kidney DiseaseTwenty participants with end stage kidney disease (ESKD) and burnt-out diabetes, and 20 non-diabetic participants with ESKD will wear a continuous glucose monitoring (CGM) device for 10 days to see if the use of CGM is a better tool to assess glycemic control than glycosylated hemoglobin (HbA1c) in patients with ESKD on dialysis.
Symptom Monitoring in Hemodialysis
End Stage Kidney DiseaseThe SMaRRT-HD trial is a cluster randomized trial of symptom monitoring with supported clinician follow-up using the SMaRRT-HD electronic patient reported outcome measure (ePROM) system versus Usual Care. Approximately 2400 patients at 30 geographically and racially diverse US hemodialysis clinics will be enrolled. The primary trial hypothesis is that regular symptom patient reported outcome measure (PROM) administration with supported clinician follow-up in dialysis care will reduce suffering and improve outcomes by prompting treatment of unrecognized symptoms, and enhancing patient-care team communication. Clinics randomized to the SMaRRT-HD group will adopt the use of SMaRRT-HD for 12 months. SMaRRT-HD is a symptom monitoring system that includes 1) tablet-based symptom reporting using a PROM and 2) supported clinician follow-up consisting of symptom alerts, guidances for symptom management, and symptom tracking reports that are shared with patients. Dialysis clinics randomized to Usual Care will not adopt SMaRRT-HD or any other trial-driven procedures. Usual Care clinics will monitor symptoms through clinical care interactions with participants and by administering a Health Related Quality of Life survey that includes questions about symptoms.
Trial to Evaluate and Assess the Effect of Comprehensive Pre-ESKD Education on Home Dialysis Use...
Chronic Kidney DiseaseEnd Stage Renal Disease2 moreThis 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.