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End Stage Renal Disease clinical trials

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NCT ID: NCT06199609 Completed - Clinical trials for End Stage Renal Disease

Changes in Cardiac Structure and Function After Establishment of Autologous Arteriovenous Fistula

Start date: September 1, 2022
Phase:
Study type: Observational

This study is a retrospective cohort study aimed at evaluating the impact of autologous arteriovenous fistula (AVF) on the heart, especially the left atrial structure, in patients with end-stage renal disease (ESRD) through a retrospective cohort study. The aim is to further clarify the relationship between the establishment of AVF and the occurrence of atrial fibrillation, and provide a theoretical basis for exploring the relevant mechanisms of AVF induced atrial fibrillation in the future.

NCT ID: NCT06064994 Completed - ESRD Clinical Trials

Impact Of Mindfulness Meditation On Pain, Quality Of Sleep, Self-Esteem

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

Background: Hemodialysis affects patients' lives and is associated with social, occupational, psychological, and societal problems. Mind-body interventions (MBIs), like mindfulness meditation, have been gaining popularity in the health sector. Pain, sleep quality, and self-esteem have all been positively impacted by MBIs in patients with end-stage renal disease (ESRD). Health care providers may be able to provide more thorough care if they are aware of these interventions. Purpose: To assess the impact of mindfulness meditation on pain, quality of sleep, and self-esteem, and self-management in patients with ESRD undergoing hemodialysis in Jordan. Methods: An experimental repeated measure, randomized, parallel control design was conducted on 60 patients with ESRD undergoing hemodialysis between March and June 2023 in the dialysis center at Alkarak governmental hospital, Jordan. Participants were randomly assigned to the experimental (N =30) and control groups (N =30) using a simple random assignment method. The experimental group practiced mindfulness meditation for 30 minutes three times per week for five weeks during their hemodialysis treatments. The control group's patients continued to receive hemodialysis treatment as usual, with three hemodialysis sessions for five weeks without any additional intervention. The study variables for both groups were measured at baseline (T0), two weeks after intervention (T1), and at the end of intervention (T2). Variables were measured by the Numeric Pain Rating Scale (NPRS), the Pittsburgh Sleep Quality Index (PSQI), and the Rosenberg Self-Esteem Scale (RSES-M) questionnaire. Descriptive statistics like frequency, mean, and standard deviation were used to describe participants. The repeated measures ANOVA (within-subject) tests were used to examine the study hypotheses.

NCT ID: NCT06064708 Completed - Clinical trials for End Stage Renal Disease

The Impact of Mindfulness-Based Intervention on Pro-Inflammatory Cytokines

Start date: April 10, 2023
Phase: N/A
Study type: Interventional

Background: Hemodialysis is considered as an effective therapy to remove harmful wastes from the body and to improve the quality of life in patients suffering from end-stage renal disease (ESRD). However, patients who receive hemodialysis perceive various stressors that are harmful to their physical and psychological well-being, particularly the immune system. Therefore, it is necessary to implement effective and practical therapeutic strategies to enhance the quality of life in this population. Mindfulness-based intervention is an effective mind-body connection program that is inadequately used in patients undergoing hemodialysis. Objective: The current study aimed to investigate the effect of mindfulness-based intervention on physical and psychological symptoms (e.g., stress, anxiety, and depression) and pro-inflammatory biomarker levels (e.g., TNF, interleukin-6, and C-reactive protein) in patients with ESRD undergoing hemodialysis. Method: Repeated measures, randomized, control experimental design was used. A convenience non-probability sampling technique to select the sample from the hemodialysis unit in the Princess Haya Bint AL_Hussine Hospital. The participants who were eligible and agreed to participate were randomly distributed into experimental (n = 31) and control (n = 30) groups. During their hemodialysis sessions, the experimental group' participants practiced 30-minute mindfulness-based intervention; three times a week for eight weeks). The Mindful Attention Awareness Scale (MAAS), Depression, Anxiety, and Stress Scale - 21 (DASS-21), Patient Health Questionnaire (PHQ-15), and serum blood levels (for tumor necrosis factor, interleukin-6, and C-reactive protein) were used to measure the dependent variables for both groups at baseline, after five weeks of the intervention, and at its end (eight weeks).

NCT ID: NCT05930964 Completed - Clinical trials for Chronic Kidney Diseases

Validity of Low Physical Activity Questionnaire (LoPAQ)

Start date: April 26, 2023
Phase:
Study type: Observational

The goal of this observational study is to assess validity and reliability of Persian Version of Low Physical Activity Questionnaire. The main questions it mains to answer are: What is the level of physical activity in hemodialysis patients? Is Persian Version of Low Physical Activity Questionnaire, Valid to assess physical activity levels of dialysis patients? Is Persian Version of Low Physical Activity Questionnaire, reliable? Participants will answer 3 questionnaires and will do some functional tests.

NCT ID: NCT05797766 Completed - Clinical trials for End-stage Renal Disease

Efficacy Trial of Fluid Distribution Timetable

Start date: January 18, 2023
Phase: Phase 3
Study type: Interventional

Nonadherence to fluid restriction is a significant issue among hemodialysis patients globally, with numerous adverse health outcomes. These outcomes include increased intradialytic weight gain, acid-base and electrolyte imbalances, and decreased mental health. This study aimed to determine the effects of a fluid distribution timetable on adherence to fluid restriction among patients with end-stage renal disease undergoing hemodialysis. The study utilized a single-blind, randomized-controlled efficacy trial design. Selected ESRD patients undergoing hemodialysis are then randomized using computer-generated sequences of randomly permuted blocks stratified according to sex to receive the intervention or the control group. Adherence to fluid restriction was measured using the dialysis thirst inventory and intradialytic weight gain. The variables were computed using One-way Repeated Measures Multivariate Analysis of Variance and Multivariate Analysis of Covariance. Secondary outcomes included baseline patient demographic profile and was compared according to group allocation. Both group were followed up for four weeks, assessing the outcome measures during the third hemodialysis session for each week

NCT ID: NCT05769595 Completed - Clinical trials for Kidney Failure, Chronic

Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012)

Start date: June 14, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-2060 after a single dose intravenous (IV) administration in Japanese older participants with end stage renal disease (ESRD) on dialysis. There is no primary hypothesis for this study.

NCT ID: NCT05743998 Completed - Clinical trials for Chronic Kidney Diseases

Inactivity and Quality of Life in Dialysis Patients

Start date: February 28, 2023
Phase:
Study type: Observational

The goal of this observational study is to compare hemodialysis and peritoneal dialysis patients. The main questions it mains to answer are: - What is the level of physical activity in hemodialysis and peritoneal dialysis patients? - What is the level of quality of life of hemodialysis and peritoneal dialysis patients? - Is there any relation between inactivity and quality of life in hemodialysis and peritoneal dialysis patients? Participants will answer 2 questionnaires and will do some functional tests.

NCT ID: NCT05692089 Completed - Clinical trials for End Stage Renal Disease

Incidence of Infective Endocarditis in End Stage Renal Disease Patients on Hemodialysis by Transesophageal Echocardiography in Assuit University Hospital

Start date: February 1, 2023
Phase:
Study type: Observational

1. To detect in more detail the incidence of infective endocarditis in patients with end stage renal disease (ESRD) on hemodialysis. 2. To compare the relationship between different forms of haemodialysis access type and the related incidence of infective endocarditis. 3. To determine individual risk factors, including type of vascular haemodialysis access, previous valve lesion and immunocompromised patients.

NCT ID: NCT05614362 Completed - Inflammation Clinical Trials

Channa Striatus Extract on Albumin and Hs-CRP ESRD

Start date: January 1, 2021
Phase: Phase 4
Study type: Interventional

This study is a randomised, double blind, placebo-controlled study in patients with ESRD on HD or CAPD based RRTs at Moewardi General Hospital in Surakarta, Indonesia from January to March 2021. Subjects were randomized to either a Channa striata or a placebo group and were given a three times daily dosage of 500 mg of Channa striatus extract or 500 mg maltodextrin, respectively for 21 days. Serum albumin and hs-CRP were measured at the baseline, and at the end of the study

NCT ID: NCT05610683 Completed - Clinical trials for End Stage Renal Disease (ESRD)

Comparison of the Removal of Uremic Toxins With Medium Cut-off and Super High-flux Vitamin E-coated Dialyzers

E-FLUX
Start date: June 14, 2023
Phase: N/A
Study type: Interventional

End-stage renal disease (ESRD) induces an accumulation of uremic toxins responsible for increased morbidity and mortality. These toxins cover a wide range of molecules, classified according to their molecular weight as small-size (< 500 Da), middle-size (500 Da-60 kDa), and protein-bound toxins. Specific complications have been associated with the accumulation of middle-size toxins, including beta2-microglobulin (12 kDa), myoglobin (17 kDa), prolactin (23 kDa), alpha1-microglobulin (33 kDa), alpha1-glycoprotein (44 kDa), kappa (22 kDa) and lambda (45 kDa) free light chains (FLC). Moreover, mediators of oxidative stress such as asymmetric dimethylarginine, malondialdehyde, oxidative-LDL and inflammatory cytokines such as Interleukin-6 (IL)-6, IL1-β, TNF-α have been involved in atherosclerosis, malnutrition, cardiovascular events and mortality. Hemodialysis (HD) remains the main standard modality of renal replacement therapy in ESRD. In the past decade, low-flux hemodialysis was most commonly used, providing effective clearance of small solutes through diffusion, but negligible clearance of middle molecules. This limitation was insufficiently improved by the development of high-flux (HF) dialyzers due to their cut-off pores size values of approximately 15-20 kDa. In fact, most of middle molecules cannot be efficiently removed by HF-HD because of their molecular radii larger than that of membrane pores. Thus, HF dialyzers were used in post dilution on-line hemodiafiltration (OL-HDF) mode with high convection volumes and achieved greatest clearance of middle molecules. However, OL-HDF is generally not available in most HD centers and needs additional hardware technology. Therefore, several super high-flux (SHF) dialyzers integrating higher cut-off size pore value and achieving Beta2-microglobulin clearance > 70 ml/min were developed for HD mode. These SHF dialyzers used in HD (SHF-HD) provides similar middle molecules depuration compared to OL-HDF. The recently developed medium cut-off (MCO) dialyzer (Theranova 500™, Baxter healthcare Corporation Deerfield, USA; surface area 2 m², ultrafiltration coefficient: 59 ml/h/mmHg) differs from conventional HF membranes by higher and controlled porosity resulting in a steep sieving curve with a cut-off value approaching that of albumin. MCO-HD has demonstrated efficient depuration of middle uremic toxins as compared to HF-HD, similar to that of OL-HDF. MCO-HD and SHF-HD are two new large pore size dialyzers currently used nowadays in HD. In addition, the interaction between blood and membrane surface play a key role in generating oxidative stress and inflammation. Antioxidants such as vitamin E work by inhibiting LDL oxidation and by limiting cellular response to oxidized LDL. In HD patients, vitamin E may be integrated as a part of the HD procedure in the form of bioreactive dialysis membranes, in which the blood surface has been modified with alpha-tocopherol. Dialysis with vitamin E-coated membranes has been associated with an improvement in biocompatibility including circulating lipid peroxidation biomarkers and cytokine induction. In small studies, vitamin E coated dialyzers have been associated with reduced red blood count fragility and improvements in erythropoietin resistance index and erythropoietin requirements in HD. VieX (Polysulfone, surface area: 2.1 m², sterilization gamma, ultrafiltration coefficient: 104.3 ml/h/mmHg, Asahi Kasei Medical, Japan), a novel SHF vitamin E-coated (SHVE) dialyzer, which has larger pore size than HF dialyzer, might provide higher middle molecules removal and biocompatibility improvement. The aim of the present study was to compare the efficiency of the SHFVE dialyzer (VieX™) versus the MCO dialyzer (Theranova 500™) on the removal of beta2-microglobulin and other middle molecules in a non-inferiority fashion, and their respective effects on inflammation, oxidative stress and biocompatibility parameters.