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Hemodialysis clinical trials

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NCT ID: NCT03058874 Recruiting - Hypertension Clinical Trials

Effect of Dry-weight Probing Guided by Lung-Ultrasound on Ambulatory Aortic Blood Pressure and Arterial Stiffness in Hemodialysis Patients (LUST Sub-Study)

LUST ABPM
Start date: September 1, 2016
Phase: N/A
Study type: Interventional

The most common co-morbidity accompanying Chronic Kidney Disease (CKD) is hypertension, which appears in approximately 80% of all patients with renal dysfunction, whereas its prevalence in general population is remarkably lower appearing in approximately 30% of adults.Defining hypertension in ESRD patients under maintenance dialysis is a challenging procedure. Ambulatory blood pressure monitoring (ABPM) is considered the "gold standard" for the diagnosis of hypertension in hemodialysis patients over the last years. The major pathophysiologic mechanism underlying hypertension development in patients with ESRD under hemodialysis is water and sodium overload. Identifying an accurate and objective method of dry weight evaluation has been a matter of intensive nephrology research for more than two decades. Assessment of the water balance in hemodialysis patients on the basis of common clinical criteria (e.g. leg or face swelling or signs of lung congestion) is a subjective method with limited reliability, despite its widespread use. Recently, a novel technique has been developed to quantify water excess by conducting an ultrasound lung scan. Pilot studies have shown significant changes in lung water in hemodialysis patients according to body weight changes during interdialytic days and dialysis sessions. Moreover, results from previous studies indicate significant benefits from dry weight probing with regards to blood pressure (BP). The clinical application of a lung-ultrasound-based volume control strategy in hemodialysis patients is currently being tested by the randomized study entitled "Lung water by ultrasound guided treatment to prevent death and cardiovascular complications in high risk end stage renal disease patients with cardiomyopathy (The LUST Study)". This clinical trial aims at evaluating whether the use of the number of US-B lines could be used as a biomarker to guide a per-protocol intensification of ultrafiltration (UF) in order to reduce volume overload, improve cardiac function and prolong survival. Cardiovascular disease in patients with CKD is attributed to a spectrum of structural and functional alterations of the large and the small branches of the arterial tree. The most important process in patients with advanced CKD is that of arteriosclerosis, which is developed in parallel to atherosclerosis and is typically associated with impaired cushioning function of the aorta and the large conduit arteries. Accelerated arterial stiffening is involved in the development of isolated systolic hypertension, left ventricular hypertrophy (LVH) and congestive heart failure (CHF), which predispose to arrhythmias and sudden cardiac death. In the context of the phenomenon of "aortic-to-brachial BP amplification", systolic BP (SBP) and pulse pressure (PP) conventionally measured at the level of brachial artery are higher than the relevant pressures in the ascending aorta. Due to extreme elevation of arterial stiffness, BP amplification is disturbed in patients with ESRD. Prospective cohort studies have demonstrated that elevated central PP, wave reflections and arterial stiffness, as well as, reduced PP amplification represent strong and independent predictors of all-cause and cardiovascular mortality in hemodialysis patients. On this basis, estimation of central BP indices appears as an important tool towards optimisation of cardiovascular risk stratification in ESRD as well as in other diseased populations. Until recently, available devices for ABPM evaluated BP levels only at the level of brachial artery. The newly developed Mobil-O-Graph NG (IEM, Stolberg, Germany) provides the ability to monitor central aortic pressure and indices of vascular resistance, such as wave reflections (augmentation index, AIx) and arterial stiffness (pulse wave velocity, PWV).This device has recently been validated in hemodialysis patients and showed comparable performance with the widely used tonometric SphygmoCor device (ArtCor, Sydney, Australia). Accumulated evidence over central BP and PWV in hemodialysis patients derives mostly from studies that included only static pre-dialysis and post-dialysis measurements. However, variations of BP levels during intra- and interdialytic intervals combined with the superiority of aortic BP measurements, as analysed above, indicate that ambulatory monitoring of central BP is the best available method. This study aims for the first time to evaluate the outcome of a treatment strategy for dry weight probing, based on volume overload quantification with lung ultrasound, on 24-hour aortic systolic BP and arterial stiffness in hemodialysis hypertensive patients. This is a Lust Sub-Study. Additional information can be found at: NCT02310061.

NCT ID: NCT02993380 Active, not recruiting - Hemodialysis Clinical Trials

Effect of Olive Oil on Erythrocyte Membrane Fatty Acid Contents in Hemodialysis Patients

Start date: October 2015
Phase: N/A
Study type: Interventional

Patients with chronic kidney disease (CKD) have higher mortality rate than general population. Especially, the most common cause of mortality was known as cardiovascular disease that account for almost 50 percent in patients with dialysis. Mediterranean diet was reported for lowering risk of coronary artery disease in general population. Mediterranean diet is not acceptable in CKD patients because of restriction of potassium, phosphorus, and protein. Relatively proper food among Mediterranean diet for hemodialysis patients is olive oil. Many researchers usually preferred olive oil as control group for evaluating effect of omega-3 fatty acid. However, previous studies reported that control groups using olive oil of 3g in a day have shown increased components of omega-3 fatty acid such as eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA). Therefore, cardioprotective effect of olive oil may be associated with increasing of omega-3 fatty acid levels.

NCT ID: NCT02943330 Completed - Hepatitis C Clinical Trials

Depression, Genes, Cytokines, Chronic Fatigue, Physical Illnesses and Quality of Life

Start date: August 2007
Phase: N/A
Study type: Observational

Depression is one of the most common psychiatric diseases, with prevalence estimates ranging from 5% to 20%. Depression is now recognized as a brain disease; it can be managed and treated effectively with a wide range of options, but its biological basis is still far from clear. Studies of monozygotic and dizygotic twin pairs suggest polygenic inheritance, with an overall heritability estimate between 40% and 70 %. Gene-environment interaction has been recognized for a long time in the pathophysiology of depression, and its best biological substratum at present is represented by the serotonin transporter (5-HTT) gene. It would be interesting to study association between the novel allelic variants or at least the triallelic 5-HTTLPR polymorphism and depression. Depression is common in patients with end-stage renal disease and to occur in about 20% to 30% of hemodialysis patients. Interferon-induced depression is estimated up to 50% among patients with hepatitis C. Several sets of observations support the supposition that cytokines, and proinflammatory cytokines in particular, are involved in depressive disorders. Depression sufferers have been reported to have elevated blood levels of interleukin 1 (IL-1), IL-6 and tumor necrosis factor α (TNF-α).

NCT ID: NCT02917278 Recruiting - Clinical trials for End-Stage Renal Disease

Pilot Study of Nutrition in Maintenance Hemodialysis Patients

Start date: February 2016
Phase: N/A
Study type: Interventional

This pilot study aims to produce preliminary data on the safety of providing high-protein meals to patients during dialysis, and effects of this intervention on nutritional status and quality of life outcomes. This is a non-randomized, parallel arm study. Meals provided will follow recommended dietary guidelines for HD patients and will provide approximately 1/3 of daily recommended protein intake. Patients will be allocated to either the treatment or control group by HD shift schedule. 2 months of baseline data will be collected, followed by 9 weeks of meal intervention/control and data collection. The primary outcome will be frequency of hypotensive events during dialysis requiring intervention. Secondary outcomes will include highest and lowest systolic blood pressure during dialysis, blood biochemistries including measures of renal function, nutritional status, and electrolyte balance; dialysis compliance; fluid retention; sleep and other quality of life measures; and dietary intake data.

NCT ID: NCT02904343 Not yet recruiting - Hemodialysis Clinical Trials

Evaluation of Domestic Hemodialysis Machine: A Multi-center Clinical Study

Start date: September 2016
Phase: Phase 3
Study type: Interventional

An important reason for the costs of hemodialysis treatment in China are expensive is the hemodialysis machine and related products mainly rely on imports. Hemodialysis machine is the basis equipment of the hemodialysis treatment. After years of research and development, China has had the domestic hemodialysis machine. However, due to the lack of control studies of domestic and imported hemodialysis machine, thus causing the domestic hemodialysis machine promotion has been hindered. The aim of this study is to verify the quality and safety of domestic hemodialysis machine.

NCT ID: NCT02786849 Recruiting - Hemodialysis Clinical Trials

Neuromuscular Electrical Stimulation During Hemodialysis in Peripheral Muscle Strength and Exercise Capacity

Start date: June 2015
Phase: N/A
Study type: Interventional

The objective of this study will be to evaluate the effects of neuromuscular electrical stimulation of high and low frequency and intensity, performed during hemodialysis (HD), on peripheral muscle strength, exercise capacity and muscle change and inflammation markers in patients with chronic kidney disease (CKD).

NCT ID: NCT02706808 Recruiting - Clinical trials for Chronic Kidney Disease

Resistant Starch Supplementation Effects on the Intestinal Tract Profile and Cardiovascular Markers in Renal Patients

Starch
Start date: December 2015
Phase: Phase 0
Study type: Interventional

The objective of this study is to assess whether supplementation with resistant starch from the rice-flour coffee developed by EMBRAPA, as well as from an already industrialized product (Hi-Maize of Ingredion®) could modulate the intestinal microbiota of patients with CKD ( both patients under conservative treatment, such as dialysis treatment), as well as exerting a beneficial effect with respect to reducing levels of inflammatory markers of oxidative stress, uremic toxins and in addition, markers of cardiovascular disease.

NCT ID: NCT02705417 Completed - Hemodialysis Clinical Trials

Maximizing Native Arteriovenous Fistulae Rates.

Start date: January 2012
Phase: N/A
Study type: Observational

The purpose of our study is to compare physical examination alone to color Doppler ultrasonography (CDUS) vascular mapping and physical examination in terms of outcomes of vascular access and long-term patency.

NCT ID: NCT02644941 Recruiting - Clinical trials for End Stage Renal Disease

Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis

Start date: May 24, 2016
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access.

NCT ID: NCT02639624 Completed - Hemodialysis Clinical Trials

Altering Bicarbonate Delivery During Hemodialysis to Affect Filtration of Indoxyl Sulfate

Start date: January 2016
Phase: N/A
Study type: Interventional

This is a non randomized crossover trial investigating whether changing the pattern of bicarbonate administration during hemodialysis will result in the more efficient filtration of highly protein bound solutes. The experimental group will be dialyzed with low bicarbonate dialysate for the first half of dialysis then switched over to normal bicarbonate dialysate for the second half. The control group will be dialyzed entirely with normal bicarbonate dialysate. The two groups will switch one week late and patients will serve as their own matched controls for a completely standard dialysis and one that is split into two halves with different bicarbonate concentrations.