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Hemodialysis clinical trials

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NCT ID: NCT05889130 Recruiting - Hemodialysis Clinical Trials

Investigation of the Effectiveness of Intradialytic Resistance Exercise Time

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

The study consists of two groups doing resistance exercise for the first and last two hours of the HD session. The investigators are planning to form the sample size of exercise training from 40 participants, which the investigators determined according to the power analysis the investigators have done based on the blood pressure outcome criterion. Participants who meet the inclusion criteria the investigators have set will be divided into two groups. A resistance exercise training will be given three days a week for eight weeks, with a total of 24 sessions. The number of IRCAs occurring in both groups and blood pressure values to be measured at the beginning and end of the HD session will be checked, and both parameters will be compared between the groups before and after the treatment after 8 weeks of training. Thus, the investigators aim to show how the time factor has an effect on blood pressure. In addition, muscle strength, physical performance and quality of life of participants before and after resistance exercise will be evaluated and compared between groups. The participants' blood pressure will be evaluated with a conventional cuffed sphygmomanometer, muscle strength, digital hand dynamometer, physical performance, Short Physical Performance Battery and Timed Up and Go Test, and their quality of life will be evaluated with the Kidney Disease Quality of Life-36 (KDQOL-36) quality of life questionnaire. In exercise training, sandbags will be used as resistance. In our study, which the investigators planned as a randomized controlled trial, stratified randomization method will be used to distribute the gender factor homogeneously in both groups.

NCT ID: NCT05852184 Recruiting - Hemodialysis Clinical Trials

Hb Scope: A Multi-Center Validation Trial

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

The global prevalence of end-stage renal disease (ESRD) was estimated ranging 5.3 to 9.7 million patients in 2017 and is a major healthcare cost driver in both developed and developing economies. The majority of patients with ESRD, approximately 90%, received in-center maintenance hemodialysis (HD). Although HD patients are under the close supervision of a nephrologist, they are vulnerable to anemia and substantial hemoglobin (Hb) variability, which are controversially associated with poor clinical outcomes, such as all-cause mortality. The contemporary narrow target hemoglobin level recommended in the KDIGO and KDOQI guidelines, despite the ongoing debates, poses a crucial challenge in maintaining the optimal hemoglobin level in HD patients. The Big Data Center at China Medical University Hospital (CMUH) has developed a tool, Hb Scope APP, that can use the color of the HD tubing to predict real-time Hb levels by leveraging the smartphone's camera capacity and machine learning (ML) technology. The performance of the Hb Scope ML algorithm in predicting Hb > 10 g/dL can reach an accuracy of 0.93 and an AUROC of 0.99 in the testing dataset. This opens an opportunity to establish a vibrant digital ecosystem for automatic anemia management. Innovative ML tools must be appropriately regulated before these algorithms are adopted into clinical practice. Therefore, in the current validation study, we propose to do a multicenter validation trial for validating whether the Hb predicted by Hb Scope APP can achieve an area under the receiver operating curve (AUROC) of at least 0.80 in the adult HD populations from CMUH, Asia University Hospital (AUH) in Taiwan, and SEHA Kidney Care (SKC)-Central in the United Arab Emirates.

NCT ID: NCT05667090 Recruiting - Chronic Pain Clinical Trials

Effects of Multiple Mega-dose of Vitamin D3 Supplementation on Ameliorating Moderate to Severe Chronic Pain in Hemodialysis Patients

Start date: March 15, 2023
Phase: N/A
Study type: Interventional

Pain is a major complaint in hemodialysis (HD) patients. Concentrations of parathyroid hormone (PTH) >250 pg/ml are associated with chronic pain. Visual Analogue Scale (VAS) score which is used to assess the pain severity is positively related to PTH levels. This study is aimed to assess the effects of multiple mega dosages vitamin D supplementations in HD patients with chronic pain. It's a single-center, parallel, double-blind randomized control trial that administrations of 576,000 IU once a week of vitamin D3 for 4 weeks or placebo are for 120 eligible subjects. VAS and laboratory tests including serum concentrations of 25(OH)D, calcium, phosphorus, PTH and C-reactive protein will be evaluated.

NCT ID: NCT05614115 Recruiting - Hemodialysis Clinical Trials

Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD

Start date: March 21, 2023
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT05509881 Recruiting - Hemodialysis Clinical Trials

Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial

CONDOR
Start date: December 12, 2023
Phase: N/A
Study type: Interventional

This randomized controlled trial will investigate whether use of continuous glucose monitoring (CGM) vs. usual care with self-monitored blood glucose 1) enhances glycemic control, 2) reduces hypoglycemia risk, and 3) improves quality of life, diabetes distress, and fear of hypoglycemia in hemodialysis patients with diabetes mellitus.

NCT ID: NCT05498181 Recruiting - Hemodialysis Clinical Trials

Angiotensin-Neprilysin Inhibition in Hemodialysis Initiation

Start date: October 11, 2022
Phase: Phase 2
Study type: Interventional

This randomized placebo-controlled clinical trial will evaluate the effect of sacubitril/valsartan (compared with placebo) on echocardiographic measures of hypervolemia, preservation of residual renal function, and key safety parameters in incident hemodialysis patients.

NCT ID: NCT05325892 Recruiting - Diabetes Clinical Trials

Analysis of Influencing Factors of Hypotension in Diabetic Patients Undergoing Dialysis

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

Hypotension (IDH) during dialysis is a common complication in hemodialysis, and the incidence is 20-50% in hemodialysis patients, the proportion of diabetic patients with IDH is 26.7%, which is much higher than that of non-diabetic patients. Currently, there are few studies on the influencing factors and related thresholds of IDH in diabetic patients.A total of 180 eligible patients were selected from Beijing Friendship Hospital, Beijing Nuclear Industry Hospital, Beijing Daxing District People's Hospital, Beijing Zhongneng Jian Hospital. General data of patients were collected. Dialysis prescription Blood pressure biochemical parameters and cardiac color ultrasound parameters were divided into IDH group and non-IDH group according to the incidence of IDH during dialysis Logistic regression was used to analyze the influencing factors of IDH, and ROC curve was used to explore the threshold of related factors.

NCT ID: NCT05248620 Recruiting - Hemodialysis Clinical Trials

Prophylactic Antibiotic Treatment in Hemodialysis

PANTHEM
Start date: February 14, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the efficacy of prophylactic antibiotic treatment on blood stream infections and severe culture negative infections, in patients on newly started hemodialysis(HD), with a central venous catheter as vascular access.

NCT ID: NCT05211167 Recruiting - Hemodialysis Clinical Trials

Phase III Clinical Study of Recombinant Erythropoiesis Stimulating Protein Injection (rESP) in the Treatment of Anemia in Hemodialysis Patients With Chronic Renal Failure

Start date: July 1, 2021
Phase: Phase 3
Study type: Interventional

To verify the efficacy of recombinant erythropoiesis stimulating protein injection (CHO cell) in hemodialysis patients with chronic renal failure anemia maintenance treatment is not inferior to yibio.

NCT ID: NCT05179668 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

SGLT2 Inhibition in Hemodialysis

DAPA-HD
Start date: October 1, 2022
Phase: Phase 2
Study type: Interventional

The study is designed as a prospective randomized, controlled, double-blinded phase II trial to examine the effect of the SGLT2 inhibitor dapagliflozin, in comparison with placebo on cardiovascular outcome parameters in kidney failure patients undergoing replacement therapy with hemodialysis. The primary endpoint is the change (∆) in left ventricular mass indexed to body surface area (LVMi) from baseline to 6 months measured by cardiac magnetic resonance imaging. Null and alternative hypotheses: H0: There is no difference in the ∆ Left Ventricular Mass indexed to BSA after six months of treatment, comparing patients having received the SGLT2-Inhibitor Dapagliflozin versus placebo. H1: There is a difference in the ∆ Left Ventricular Mass indexed to BSA comparing patients having received the SGLT2-Inhibitor Dapagliflozin versus placebo.