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Hemodialysis Patients clinical trials

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NCT ID: NCT02859220 Completed - Clinical trials for Hemodialysis Patients

Study of the Influence of Dosages of 1-84 and 7-84 Fragments of Parathyroid Hormone Compared to Conventional Dosage on the Balance of Calcium and Phosphate in Hemodialysis (PTH)

PTH
Start date: January 2006
Phase: N/A
Study type: Interventional

This study included 80 patients with end stage renal disease requiring dialysis treatment to evaluate two techniques for the determination of parathyroid hormone (PTH) Objective: To evaluate whether the monitoring of hemodialysis patients by measurement of PTH 1-84 Complete (CAP =cyclase activating PTH) and the ratio (1-84 PTH (CAP)/7-84 PTH (CIP = cyclase inactivating PTH) with kit "Duo PTH Immunoradiometric Scantibodies" allows an improvement in the therapeutic management of abnormal calcium and phosphate, with a better match to the targets of current international recommendations, followed by the conventional intact PTH assay. Primary endpoint: For each patient, a score will be awarded based on the number of criteria (including calcium, phosphorus and calcium phosphate product) in the target international guidelines :0-1-2 or 3. The primary endpoint will be the average scores in both groups at the beginning and the end of the study, Main secondary endpoints: - Changes in the number of patients responding to international guidelines for each of the three parameters studied (serum phosphate, corrected calcium, phosphorus product) in the 2 groups, - Evolution of Elecsys intact PTH Roche in the 2 groups, - Salaries and changes in the number of drugs to normalize the phospho-calcium balance in each group received, - cardiovascular events (morbidity and cardiovascular mortality), - Total mortality. Statistical analysis: This is a randomized, two parallel arms. The investigators will compare the average number of criteria on calcium and phosphate in the target according to a Mann-Whitney. The analysis will be performed with the software Splus.

NCT ID: NCT02245633 Recruiting - Diabetes Clinical Trials

Correlation Between Vitamin D Levels to ADAMTS13 , VWF and Micro RNA Expression in Diabetic Hemodialysis Patients

Start date: September 2014
Phase: N/A
Study type: Observational [Patient Registry]

The aim of this research is to study how vitamin D affects various aspects of the disease process, such as inflammation, coagulation (ADAMTS13 and WVF) and miRNAs, in Diabetic kidney disease hemodialysis patients. Diabetes mellitus (DM) is one of the most common chronic diseases in nearly all countries. Diabetic kidney disease (DKD) traditionally has been referred to as diabetic nephropathy and is one of the microvascular complications of diabetes. Diabetic kidney disease (DKD) occurs in 25%-40% of patients with diabetes . Some studies have shown that the high risk of cardiovascular disease in diabetic patients with nephropathy is associated with increased plasma levels of von Willebrand factor (VWF) and decreased ADAMTS13 levels. VWF is a glycoprotein that plays an important role in platelet thrombus formation, whereas ADAMTS13 is a proteolytic enzyme that is responsible for degradation of large multimers of VWF released in the plasma by endothelial cells and platelets. Patients with both chronic kidney disease and diabetes have been shown to have higher plasma levels of VWF and decreased ADAMTS13 activity compared to healthy controls. Increased plasma levels of VWF, which reflects damage to endothelial cells and a hypercoagulability state, have been reported in atherosclerosis and diabetes. Thus, VWF and ADAMTS13 seem to be important players in the interface between diabetic nephropathy, hypercoagulability and atherosclerotic cardiovascular disease. Vitamin D deficiency is a risk factor for DM and hypertension. The investigators previous studies showed that adding calcitriol (activated vitamin D) to endothelial and vascular smooth muscle cells significantly down-regulated the inflammatory response of gene and protein expression involved in the nuclear factor kappa-light-chain-enhancer of activated B cells (NFĸB) signal transduction pathway. Micro RNA (miRNA) are short noncoding RNAs, 22-25 nucleotides long. As an endogenous production transcript, miRNAs can bind to the 3 untranslated regions (3 UTR) of its target messenger RNA (mRNA) in an imperfect, complementary manner, leading to post-transcriptional gene silencing. As a result, miRNAs can inhibit gene expression via mRNA degradation, translation inhibition, or transcriptional inhibition.The critical role of miRNAs has been established in several cellular and biologic processes, such as proliferation, differentiation, and development, and in the regulation of genes related to immune responses, cancer, and insulin secretion. MiRNA are involved in various biological processes and become novel biomarkers, modulators and therapeutic targets for diseases such as cancer, atherosclerosis, and DM. Significance: The high prevalence of cardiovascular morbidity and mortality in patients with DM on chronic hemodialysis remains a significant clinical problem and the finding of potential new biomarkers should be further investigated. This study aims to establish a link between ADAMTS13, VWF miRNA expression and vitamin D levels that can contribute to the development of new treatments for hemodialysis patients with diabetes. Methods: Each hemodialysis patient with diabetes in the investigators institute will be asked to participate in the study. After explaining the research goals, patients that agree to participate will sign an informed consent. The investigators estimate that the study will include 70 patients. Each patient will be assessed by a physician and 4 vials of blood will be taken while the patient is connected to the dialysis machine. The blood will be sent to the laboratory to check: 1) chemistry; 2) 1-25 vitamin D and 25- vitamin D levels; 3) ADAMTS13 activity and VWF; and 4) miRNA extraction. The patients will be grouped according to vitamin D levels (deficient /sufficient), and ADAMTS13, VWF and miRNA expression will be compared between the groups.

NCT ID: NCT01970280 Recruiting - Clinical trials for Hemodialysis Patients

Low Molecular Weight Heparin in Prevention of Recurrent Arteriovenous Graft Thrombosis in Chronic Hemodialysis Patients.

Start date: September 2013
Phase: Phase 4
Study type: Interventional

The aim of the study is to evaluate the effect of Enoxaparin (LMWH) on the incidence of AV graft thromboses in patients on chronic hemodialysis. Primary efficacy end point of the study: to compare the time of onset of a new thrombotic event after successful angiography of the AV graft. Pprimary safety outcome of the study: frequency of hemorrhage. Design and methods: Following a first AV graft thrombosis and successful thrombolysis with angioplasty, patients on chronic hemodialysis will be randomized to s.c Enoxaparin (Clexane) 0.5 mg/1kg of body weight per day or control group (not on Clexane). Patients will be followed for a year or till next AV graft thrombotic occlusion, if it occurs before. In both groups we will compare time periods in months between first and recurrent thrombotic events of AVG by evaluation the difference between two sample means. Also interim analysis of AV grafts patency between the two groups will be evaluated at different time points: three, six and twelve months after randomization. Patients in both groups will receive unfractionated heparin during dialysis session to prevent thrombosis of extracorporeal circulation. Patients from Enoxaparin group will receive a half dose (500 units/hour) to prevent possible risk of bleeding during the session. Before randomization all patients will be evaluated for hypercoagulability state which will include: Factor V Laden deficiency, Anti phospholipid antibodies (APLA), Antithrombin III deficiency and Protein C/S deficiency.

NCT ID: NCT01932853 Completed - Clinical trials for End Stage Renal Disease

Association Between Dose Dialysis by Kt and Mortality

Start date: October 2013
Phase: N/A
Study type: Observational

The aim of this study is to assess whether patients receiving current recommendations of an adequate dialysis dose by Kt adjusted for body surface area improved survival at 24 months compared to those who do not get it, as well as assess whether patients receiving a dose greater obtain more benefit.

NCT ID: NCT01896882 Enrolling by invitation - Clinical trials for Hemodialysis Patients

Dietary Sodium Restriction in Hemodialysis Patients

Start date: March 2012
Phase: N/A
Study type: Interventional

Excess dietary sodium can lead to poor outcomes, such as hypertension, edema and increased risk for cardiovascular diseases. These complications are associated with end stage renal disease (ESRD) progression and mortality in renal patients. This study aims to evaluate the effects of nutritional counseling restricting dietary sodium and its relation to clinical and diet factors, nutritional knowledge and quality of life in hemodialysis patients.

NCT ID: NCT01866891 Completed - Clinical trials for Hemodialysis Patients

Effects of Physical Activity on the Microcirculation in Hemodialysis Patients

ACTIVDIAL
Start date: April 2012
Phase: N/A
Study type: Interventional

Chronic kidney disease (CKD) is associated with high level of peripheral arterial disease (PAD). This could lead wounds, infections then amputations or deaths by impairment of the peripheral cutaneous perfusion. Medical therapies are presently unable to cure, but only slow down these disorders. Impact of exercise and lower extremity PAD rehabilitation is decreased by the significant inactivity of the chronic hemodialysis patients. Recently, many studies have shown several various favorable effects of the perdialytic physical activity. There is currently no data about effects of the perdialytic activity on the lower extremity perfusion. The aim of this clinical study is to show the impact of three months perdialytic cycling on the microcirculation, in chronic hemodialysis patients. Primary outcome will be the increase of cutaneous perfusion, assessed by measuring transcutaneous oxygen pressure (tcPO2) on about twenty patients.

NCT ID: NCT01846754 Completed - Clinical trials for Hemodialysis Patients

Prevalence of Fatigue in Hemodialysis Patients

Start date: June 2013
Phase: N/A
Study type: Observational

The prevalence of end stage renal disease in Taiwan was listed first all over the world. Fatigue, which makes patients unable to be competitive to play their functional roles, is one of the most bothersome symptoms of patients receiving long-term hemodialysis. Tracing back to the development of its relating studies, there is no accurate reason that why does people undergoing hemodialysis feel fatigued. Conclusive predictors of fatigue are still not shown up yet. Paper review indicated that the level of L-Carnitine concentration, which affect metabolism of fatty acid, had correlation with fatigue and muscle strength in this population. The serum concentration of L-Carnitine is influenced a lot by hemodialysis. When there is deficiency of energy supply, it resulted to decline of muscle strength, which increased frequency and intensity of fatigue. Hence, the purposes of this study are (1) to understand the basic condition of fatigue level, muscle and metabolism of fat and carbohydrate among hemodialysis patients, (2) to analyze correlation among muscle strength, metabolism of fat/carbohydrate, and fatigue, and (3) to understand correlations among demographic characteristics, blood test data (hemoglobin, albumin, Kt/V, urea reduction ratio(URR), blood urea nitrogen(BUN), creatinine, calcium, phosphorus, and C-reactive protein), mental and social conditions (depression, anxiety, and social support), muscle strength and fatigue, seeking further exploring predictors of muscle strength and fatigue. The study use cross-sectional descriptive correlative design with consecutive sampling. Recruit patients from a hemodialysis unit in a medical center in north Taiwan after informed- consent. The estimated sample size is 100. To understand relationship among muscle strength, by-products of fatty acid and carbohydrate and fatigue, we collect data by measuring their muscle strength (handgrip and 30 seconds sit-to-stand), and analyzing blood test data and the structured questionnaires which included mental/social data (depression, anxiety, social support and fatigue level). Descriptive statistics, ANOVA, Pearson's correlation, Spearsman's rank correlation and stepwise regression were used to analyze the collected data. Hope this research can get advance in comprehension of cause of fatigue and improve the fatigue symptom of hemodialysis patients.

NCT ID: NCT01596842 Completed - Clinical trials for Vitamin D Deficiency

Effect of Omega-3 Fatty Acid on Vitamin D Activation

Start date: May 2012
Phase: Phase 4
Study type: Interventional

Extra-renal sources of 1, 25-dihydroxyvitamin D can be increased to normal serum 1, 25-dihydroxyvitamin D levels in chronic kidney disease patients after administration of high dose 25-hydroxyvitamin D. The investigators observed that 1, 25-dihydroxyvitamin D concentrations were significantly increased after 3 months of omega-3 FA supplementation compared to baseline levels without 25-hydroxyvitamin D administration in dialysis patients. In this study, the investigators hypothesized that omega-3 FA and 25-hydroxyvitamin D supplementations may increase 1, 25-dihydroxyvitamin D concentrations much more compared to 25-hydroxyvitamin D supplementation only in hemodialysis patients with insufficient or deficient 25-hydroxyvitamin D levels.

NCT ID: NCT01273974 Completed - Clinical trials for Hemodialysis Patients

The Immunogenicity of Intradermal Influenza Vaccination in Hemodialysis Patients

Start date: October 2009
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine whether half-dose intradermal influenza vaccine is as immunogenic as standard dose intramuscular vaccine in hemodialysis patients.

NCT ID: NCT01114789 Recruiting - Clinical trials for Hemodialysis Patients

Impact on the Proteolysis of Obesity in Dialysis

IPOD
Start date: January 2011
Phase: N/A
Study type: Interventional

The objective of this study is to determine whether obesity has a protective effect on muscle proteolysis in hemodialysis patients submitted to a short starvation. This effect will be tested by comparing measuring muscle proteolysis, using regional infusion of a tracer amino acid (D5 phenylalanine) in two groups of obese and non-obese patients compared to obese and non-obese control subjects.