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Peritoneal Dialysis clinical trials

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NCT ID: NCT04730830 Recruiting - Peritoneal Dialysis Clinical Trials

Occurrence of Emerging Infections After Placement of a Peritoneal Dialysis CatHeter

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

Peritoneal dialysis, which appeared at the end of the 1970s, quickly proved its worth both in terms of its effectiveness and of its ease of compliance, which guarantees an improved quality of life. To date there are different modes of application of this technique: Continuous Ambulatory Peritoneal Dialysis, and Automated Peritoneal Dialysis. Whatever the technique used, the placement of a dressing covering the exit site of the catheter is necessary just after the placement of the PD catheter and this so that the site of emergence is kept dry until healing (in general 2 to 4 weeks). Once the emergence site has healed, the technique can be started. Discharge site infections are a major predisposing factor for the development of peritonitis. Numerous studies in different parts of the world have shown that the rates of PD-related infections have steadily declined over the past 10 to 20 years. Several recommendations for the prevention and treatment of emergence site infections have been published by the International Peritoneal Dialysis Society. Several studies nonetheless call into question the recommendations by showing that catheter infection is not linked to the number of risk factors present at the time of catheter insertion, nor to the prescription of antibiotic prophylaxis, nor to the the experience of the caregiver, the antiseptic used or the early dressing change. In addition, only antibiotic prophylaxis at catheter placement is strongly recommended. Regarding the other measures, their relevance is not always demonstrated and their application varies considerably from one center to another. In addition, many authors have sought to establish a definition of catheter infections in order to allow an optimal assessment of their frequency. However, these definitions are not universal and have certain limitations. The objective of this work is on the one hand to better characterize the incidence of infections at the site of emergence in peritoneal dialysis, and on the other hand, in the absence of a definition established according to the recommendations, to use the score de Schaeffer, is in particular the value of this score which would make it possible to define more precisely the presence of an infection.

NCT ID: NCT04666844 Completed - Peritoneal Dialysis Clinical Trials

Predicting Transfers to Hemodialysis in Peritoneal Dialysis Patients Using the Surprise Question

Start date: November 20, 2020
Phase:
Study type: Observational

The investigators will assess the prediction performance of the modified Surprise Question (Will the participant be surprised if this patient transfers to hemodialysis in the next 6 months?) for identification of peritoneal dialysis at high risk of transfer to hemodialysis. The investigators will also assess the prediction performance of a modified mortality surprise question (Will the participant be surprised if this patient dies in the next 6 months?).

NCT ID: NCT04628117 Not yet recruiting - Malnutrition Clinical Trials

Effect of Oral Nutritional Supplementation on Oxidative Stress in Protein-energy Wasting Patients With Peritoneal Dialysis

Start date: October 4, 2021
Phase: N/A
Study type: Interventional

End-stage kidney disease (ESKD) represents a serious public health problem in Mexico. Data from the United States Renal Data System (USRDS) have reported that the region of Jalisco (Mexico) is one of the places with the highest incidence rate of treated ESKD and use of peritoneal dialysis (PD). In patients with ESKD, oxidative stress (OS) has been recognized as a potential source of morbidity and mortality, since it is involved in the pathogenesis of atherosclerosis and other complications of ESRD. This can induce damage to DNA (nucleic acid), proteins, carbohydrates, and lipids. Another common complication in ESKD patients receiving PD is protein-energy wasting (PEW), which is characterized by the decline in the body stores of protein and energy fuels (that is, body protein and fat masses) due to the multiple nutritional and catabolic alterations that occur in this condition. Diverse factors can affect the nutritional and metabolic status of patients with PD, for which they require interventions to reverse protein and energy depletion. Nutritional counseling can be a useful tool in PD patients in order to improve compliance with nutritional recommendations. The strategies more used for PEW include oral nutritional supplementation. Therefore, the purpose of this study is assess the effect of oral nutritional supplementation on OS in PEW patients with PD.

NCT ID: NCT04603014 Recruiting - Hemodialysis Clinical Trials

Interdialytic Peritoneal UltraFiltration in HemoDialysis Patients

IPUF-HD
Start date: January 1, 2021
Phase: Phase 2
Study type: Interventional

Sodium accumulates in the tissues of patients with kidney disease and impairs survival. Three-times weekly, standard hemodialysis alone cannot remove excess sodium efficiently. A sample of 10 chronic hemodialysis patients will undergo a 5-week, pilot, interventional study to test the efficacy of additional sodium removal in-between hemodialysis sessions, twice per week, for three weeks. Tissue sodium removal will be achieved with peritoneal dialysis after the surgical insertion of a peritoneal dialysis catheter. Tissue sodium removal will be assessed at the beginning and at the end of the study with sodium magnetic resonance imaging of a peripheral limb (leg). Patients will also undergo monitoring for symptoms and blood pressure throughout the study to assess the safety of this procedure.

NCT ID: NCT04413266 Completed - Clinical trials for Chronic Kidney Diseases

Effects of Curcumin Supplementation in Patients With Chronic Kidney Disease on Peritoneal Dialysis

Start date: October 10, 2020
Phase: N/A
Study type: Interventional

The objective of this study is to assess whether supplementation with curcumin could modulate the intestinal microbiota, reducing levels of inflammatory markers of oxidative stress, uremic toxins and inflammasome, in patients with chronic kidney disease in peritoneal dialysis.

NCT ID: NCT04292210 Completed - Renal Failure Clinical Trials

Human Factors Validation Testing for the Peripal System; a Manual Connection Assist Device for Peritoneal Dialysis Devices

Start date: February 19, 2018
Phase: N/A
Study type: Interventional

It is estimated that there are currently over 3 million patients receiving dialysis treatment worldwide. With effective pre-dialysis counselling, a majority of patients choose the home-based therapy peritoneal dialysis (PD) but only approximately 11% of prevalent dialysis patients use this modality. Connection-assist devices can overcome the challenges posed by decreased manual dexterity and/or visual acuity, and can allow more patients to be treated with home-based therapies. As part of the CE marking authorization, a connection device has been evaluated for safety and ease of use in a usability study.

NCT ID: NCT04238338 Recruiting - Inflammation Clinical Trials

Association of MLR With Risk of Death and Cardiovascular Events in PD Patients

Start date: June 1, 2020
Phase:
Study type: Observational

The current incidence of chronic kidney disease (CKD) in China is approximately 10.8%, with approximately 119 million patients. Among them, patients with end-stage renal disease (ESRD) are about 200-250 cases per million population. At present, the main renal replacement therapy is: hemodialysis (HD) or peritoneal dialysis (PD). Compared with HD, PD is easy to operate, better preserves residual renal function, has early survival advantages, and is more cost-effective. Despite this, the prognosis of PD patients is still not ideal, and cardiovascular disease (CVD) remains the leading cause of death in PD patients. Persistent inflammatory states are critical in the pathogenesis of CVD such as atherosclerosis and vascular calcification, and lead to protein energy expenditure and premature death outcomes in patients with CKD. Therefore, screening for markers that predict the risk of CVD in dialysis patients is essential. Some novel inflammatory markers have been shown to have diagnostic and prognostic value in ESRD patients in terms of inflammation, malnutrition, cardiovascular calcification, all-cause, and risk of CVD death. Among them, blood cell related parameters such as neutrophil / lymphocyte ratio (NLR) and monocyte / lymphocyte ratio (MLR)can reflect both inflammation and immune deficiency. NLR, MLR has been proposed as a new inflammatory biomarker and a potential predictor of cardiovascular risk. Studies have reported that MLR is associated with cardiovascular death and all-cause death risk in hemodialysis patients, and is superior to NLR. However, the relationship between MLR and the prognosis of patients with peritoneal dialysis is rarely reported. Therefore, in this study, we aimed to evaluate the association of MLR with risk of death and cardiovascular events in PD patients.

NCT ID: NCT04225416 Recruiting - Hemodialysis Clinical Trials

Perceptions of Illness Severity, Treatment Goals and Life Expectancy

ePISTLE
Start date: November 16, 2018
Phase:
Study type: Observational

This study is exploring symptom burden, health experiences and expectations of treatment and survival of seriously ill dialysis patients and their physicians.

NCT ID: NCT04199338 Enrolling by invitation - Self Efficacy Clinical Trials

The Effect of Web Based Education Based on Self-Care Deficiency Theory on Self-Care Power and Self-Efficacy and Perceived Social Support in Patients Receiving Peritoneal Dialysis

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

Web-based training based on the Self-Care Deficiency Theory has an effect on increasing self-care in in patients undergoing peritoneal dialysis. Web-based training based on Self-Care Deficiency Theory has an effect on increasing self-efficacy in patients undergoing peritoneal dialysis. Web-based education based on Self-Care Deficiency Theory has an effect on increasing perceived social support level in patients undergoing peritoneal dialysis.

NCT ID: NCT04197674 Recruiting - Hemodialysis Clinical Trials

China Q Cohort Study

Start date: January 21, 2020
Phase:
Study type: Observational

The burden of end-stage kidney disease (ESKD) is increasing worldwide. Although kidney transplantation is the most cost-effective renal replacement therapy, dialysis is still the main way to treat ESRD patients due to the limited kidney donor, with approximately 89% of such dialysis patients receive hemodialysis (HD) and the remainder receive peritoneal dialysis (PD). This distribution of dialysis modality, however, varies widely by health jurisdiction. For instance, more than 97% of dialysis patients are treated with HD in Japan, but more than 50% treated with PD in Mexico. Evidence comparing the two modalities suggests that mortality risks may be comparable, but all evidence come from observational study and there is no randomized controlled trial to compare patient survival between PD and HD due to patients enrollment issue.More importantly, for most health care systems, such as United States, United Kingdom, Australia, Indonesia and China, PD is less expensive than HD. It is possible, then, that a greater global utilization of PD might improve access to renal replacement therapy in less advanced economies. The investigators have conducted a prospective, randomized, parallel, open-label, multi-center, non-inferiority trial to evaluate health-related quality of life (HRQoL) with PD versus conventional in-center HD in incident ESKD patients. A total of 1082 ESKD patients were randomly assigned to PD or conventional in-center HD, and 235 patients enrolled in stage 1 with complete measures of the "Burden of Kidney Disease" at both baseline and 48 weeks and 668 patients enrolled in stage 2 were included in analysis. However, this trial was designed to evaluate quality of life between PD and HD and all patients were follow-up 48 weeks. Therefore, in this observational cohort study, the investigators will perform extended follow-up for participants including in analysis . Our primary objective is to evaluate the association of dialysis modality (PD and HD) with all-cause mortality in ESKD patients. The investigators also explore the impact of PD and HD on major cardiovascular event composite (MACE), a composite outcome of MACE and all-cause death, hospitalized myocardial infarction, hospitalized stroke and hospitalized heart failure, healthy utility, dialysis cost, activity of daily living, and changes of RRF, hemoglobin, and other biochemical parameters.