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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT02147002 Recruiting - Clinical trials for Chronic Kidney Disease

Omega-3 Acids and Cardio - Vascular Complications in Patients With Chronic Kidney Disease in Stage 1-3

Omega-3 acids
Start date: October 2012
Phase: N/A
Study type: Interventional

The National Register of Nephrology in 2007 shows, similarly to the European data, a problem of a high mortality rate among Polish dialysis patients. The main reason of death among chronically dialysis patients are cardio - vascular system diseases. According to "The Report on the Condition of Renal Replacement Therapy in Poland in 2007", these diseases are the cause of 53% deaths in Poland. The patients with chronic kidney disease (PChN) are particularly at risk of cardio - vascular complications. These complications occur on average 30 times more often than in the whole population, and among young dialysis people, these complications occur 300 times more often. In the development of cardio - vascular complications polyunsaturated Omega-3 acids (especially eicosapentaenoic acid - EPA and docosahexaenoic acid - DHA) take a special position. The reaction of polyunsaturated Omega-3 acids on the cardiovascular system results from the enrichment of phospholipids of cell membranes within EPA and DHA. It should be noted that their impact is dependent on the type of acid and on the dose. Docosahexaenoic acid reacts with lipids and lipoproteins, blood pressure, heart rate, amount of glucose, and eicosapentaenoic acid is responsible for antiplatelet effect. This project is aiming at defining and elaborating on the connection between Omega-3 acids, and cardiovascular complications, their influence on the functioning of the cardiovascular system, and moreover, a better understanding of the effects of therapeutic and pharmacological therapies in patients at different stages of chronic kidney disease. Carrying out this project will be a good start to shape an international project in this area.

NCT ID: NCT02132741 Recruiting - Hypertension Clinical Trials

Optical Coherence Tomography And NEphropathy: The OCTANE Study

Start date: May 16, 2014
Phase:
Study type: Observational

Patients with high blood pressure (hypertension) and chronic kidney disease are at an increased risk of developing heart disease and strokes. Part of this risk is due to changes in the structure and function of the blood vessels throughout the body. It is thought that reducing high blood pressure and treating chronic kidney disease improves the structure and function of blood vessels but information on this is limited. Optical coherence tomography (OCT) is a method of looking at the blood vessels at the back of the eye. It is a simple, quick and non-invasive test that you may have previously had during a visit to the optician. The purpose of the study is to ascertain whether OCT is able to detect changes in the eye's blood vessels in patients with hypertension and chronic kidney disease compared to healthy individuals and also to see if any differences seen improve with treatment.

NCT ID: NCT02105519 Recruiting - Clinical trials for Chronic Kidney Disease

The Effect and Safety of the Seasonal Trivalent Influenza Vaccine in Chronic Kidney Disease Patients Not on Dialysis

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

In recent years, several studies revealed that the current influenza vaccine strategy might be of minimal vaccine effectiveness and had a smaller effect on reducing morbidity and mortality in the end-stage renal disease population than previously thought. Thus, this also raised the question about the effectiveness of administration of influenza vaccination in chronic kidney disease patients not on dialysis. In this study, the investigators aim to evaluate the effectiveness of seasonal trivalent influenza vaccine, formulation 2013-2014, in patients with different stage of chronic kidney disease (CKD) not on dialysis.

NCT ID: NCT02102425 Recruiting - Clinical trials for Renal Insufficiency, Chronic

Effects by Omission of Bandage Over Exit Site

EXIT
Start date: March 2014
Phase: N/A
Study type: Observational

Peritoneal dialysis, known as p- dialysis (PD), is a dialysis form in which the blood is purified by using the body's peritoneum. PD dependents on good access to peritoneum. For this, a catheter is implanted in the peritoneum and tunneled 2-3 cm below the skin. The way out is called exit site and is close to the navel. Patients are selected at random to use bandage or not use bandage for three months, then cross-over. The overall objective of the research is that the patient in PD maintains a complete and healthy skin without signs of infection around the exit site. In the study effects by omission of bandage over exit site at patients in PD are examined when the patients are in a stable process with PD. The patient's exit site is assessed according to skin character and examined for infection. The hypothesis is that there is no greater rate of infection in patients without bandage than in patients with bandage over the exit site, and that patients without bandage will have stronger skin around exit site.

NCT ID: NCT02078115 Recruiting - Hypertension Clinical Trials

Assessment of Blood Pressure Control and Target Organ Damage in Patients With Chronic Kidney Disease and Hypertension -II

Start date: April 2013
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to find the change of blood pressure (BP) control pattern (true controlled, white-coat, masked, and sustained uncontrolled/ dipper, non-dipper, reverse-dipper, and extreme-dipper) in patients with chronic kidney disease (CKD) over 3 years. And Other objective is the relationship between the BP control pattern and the target organ damages such as renal function, proteinuria, left ventricular hypertrophy (LVH), and so on. In addition, we will find clinical factors related to the BP control pattern.

NCT ID: NCT02076256 Recruiting - Clinical trials for Chronic Kidney Diseases

The Influence of Helping Relationships From Significant Others on Healthy Lifestyle and Quality of Life Among Patients With Chronic Kidney Disease: A Longitudinal Study

Start date: August 2013
Phase: N/A
Study type: Interventional

Helping relationships from significant others may assist patients with chronic kidney diseases to exercise health behaviors. Patients will adhere on the suggestions from medical staff and perform health lifestyle to maintain healthy behavior. The progress of the disease may be delayed. The research is a 3-year study to explore the influence of helping relationships on healthy behaviors among patients with chronic kidney disease. Building on the findings from the past three years study and the literature on trans-theoretical Model, helping relationships will be articulated. A helping relation intervention will be applied to evaluate its effect on healthy lifestyle and quality of life. The first year study will be a survey design. An instrument to measure the helping relationship will be established and tested. Total of 200 participants will be recruited to test the reliability and validity of the instrument. After evaluating the psychometric properties of the instrument, items may be revised according to the results. The second year of research will be a cross-section study. Of 250 subjects will be recruited to explore the correlations between helping relationships, healthy life styles, and quality of life. Data will be analyzed using hierarchical linear regression. In the third year, an experimental design will be applied to test the effect of a helping relationship intervention. One hundred and twenty subjects will be recruited and randomly assigned to the experimental and the control group for 60 subjects in each group. The helping relationships intervention program will be implemented on the experimental group. And the control group will be provided with routine nursing care. Data will be collected at baseline, the sixth and the ninth month of the third year of study. Data will be analyzed using generalized estimating equation measures to evaluate the effect of the intervention program.

NCT ID: NCT02041156 Recruiting - Clinical trials for Chronic Kidney Disease

Effects of Different Exercise Training Programs in CKD 4-5

RENEXC
Start date: October 2011
Phase: N/A
Study type: Interventional

The investigators' purpose is to study which exercise training modality: aerobic physical activity in conjunction with either resistance training or balance training, is most beneficial in patients with chronic kidney disease (CKD 4-5: GFR < 30 ml/min/1.73mUP[2]). Furthermore, our purpose is to evaluate the long-term effects of exercise training on functional status, cardiovascular morbidity, blood pressure control, heart rate variability, cardiac function, inflammation, body composition, nutritional status, progression of uraemia and health related quality of life. This interventional study is prospective, randomized and controlled comprising 150 prevalent and incident patients from our outpatient clinic. Patients are invited to participate in the study consecutively, irrespective of basic functional status. At start patients are randomised either to resistance or balance training and the programme is adapted and individualised to each patient's actual physical status and ability. The exercise prescription is to exercise for 30 minutes/day, 5 days/week, keeping the intensity constant at a level of "somewhat strenuous" to "strenuous" on the Borg scale rate of perceived exertion. The total observation period is 12 months with checks every four months. Although exercise training is a recommended therapy in CKD, there is a lack of medical and scientific evidence on optimal prescription. We hope that this study will provide evidence-based knowledge on exercise prescription and its effects on various risk factors in CKD patients. Finally, if patients achieve a higher degree of physical functional capacity they should be able to maintain an autonomous lifestyle, resulting in considerable reductions in societal costs for care and transportation.

NCT ID: NCT02002585 Recruiting - Clinical trials for Arterial Hypertension

Renal Protection Using Sympathetic Denervation in Patients With Chronic Kidney Disease

KPS
Start date: November 2013
Phase: Phase 2
Study type: Interventional

Kidney protection study (KPS 1) is a prospective randomized clinical study comparing the use of renal denervation (RDN) and optimal medical therapy in subjects with chronic kidney disease stage 3-4 and resistant arterial hypertension to optimal medical therapy alone. Renal denervation is a modern endovascular method used to treat resistant hypertension. The method is being extended to other groups of patients, where the sympathetic tone is increased beyond resistant hypertension. Because of the character of the disease, we hypothesize that renal denervation can reduce or prevent progressive deterioration of kidney functions in this patient population. The aim of this clinical study is to show that renal denervation has protective effects on the progression of chronic renal insufficiency.

NCT ID: NCT02000895 Recruiting - Clinical trials for Cardiovascular Diseases

Early Detection of Progressive Kidney Disease in Preterm Infants

Start date: July 23, 2011
Phase:
Study type: Observational [Patient Registry]

Infants born preterm and of low birth weight are known to be at increased risk for early onset of cardiovascular and renal disease in adult life. This has been related to low nephron mass due to inadequate or early termination of glomerulogenesis in utero and during the perinatal period. Risks for subsequent development of hypertension and kidney disease include proteinuria, excessive weight gain during early life with insulin resistance and supplemental high calorie feedings. The long-term goal is for early diagnosis of those infants who are at risk for future development of hypertension and kidney disease so that the investigators might intervene to potentially avert progression to adult disease. The objective of this clinical trial is to acquire data on the natural history of neonatal kidney function and size in infants born preterm during the first 2 years of life. This will be done through the use of standard serum and urine markers as well as non-invasive ultrasound technology. The central hypothesis of this clinical trial is that a subgroup of patients born preterm and of low birth weight will demonstrate early markers of kidney injury including elevated serum cystatin C, proteinuria and low kidney size. This hypothesis has been formulated on the basis of preliminary data from our group studying this question retrospectively in older children born prematurely who have developed overt kidney disease. The rationale for the proposed research is to develop early serum and demographic markers of pre-clinical kidney disease so that early intervention can occur. The proposed clinical trial is innovative because it will investigate the risk factors for kidney dysfunction at a pre-clinical stage with the idea of gaining more knowledge regarding therapeutic interventions. In addition, the study will assess serum cystatin C as a surrogate test for glomerular filtration rate which could indicate worsening kidney function at an earlier stage than serum creatinine. The proposed research is significant because it is expected to identify at-risk patients for future renal impairment and to prospectively monitor the persistence of proteinuria and its effect on kidney function in the short term.

NCT ID: NCT01977430 Recruiting - Clinical trials for Chronic Kidney Insufficiency

Clinical Trial to Compare Effectiveness of Diuretics in Hemodialysis Patients With Residual Renal Function

RRF
Start date: November 2013
Phase: Phase 4
Study type: Interventional

Introduction: Chronic kidney disease is characterized by a progressive deterioration of renal function. At the end of the progression, when complications occur (overhydration, electrolyte imbalances or retention of uremic toxins), a percentage of patients requiring renal replacement therapy (haemodialysis). When starting the haemodialysis, the patient holds the residual renal function (RRF) which is lost over time. To preserve the RRF, the patient is treated with diuretics loops and / or thiazide diuretics. The effect of this treatment is lost when renal function worsens. In this context, there are few studies that explore the use and effectiveness of diuretics in patients on haemodialysis 2. Objectives and Hypothesis: Hypothesis: The treatment with furosemide and hydrochlorothiazide in haemodialysis patients with RRF could: - To decrease in weight gain between haemodialysis sessions. - To increase urine volume. - To decrease the ultrafiltration in haemodialysis sessions ( the long interdialytic interval) Main Objective:To asses the effect of combined hydrochlorothiazide-furosemide therapy on gain weight between haemodialysis sessions in patients with RRF Secondary Objective: To asses the effect of combined hydrochlorothiazide-furosemide therapy on dialytic, clinical and analytical variables and use of the antihypertensive treatment 3. Methodology: Randomized open clinical trial to compare the effectiveness of the administration of diuretics in haemodialysis patients with residual renal function in single centre. The population of study are patients with chronic renal disease in haemodialysis therapy that they preserve residual renal function ( more 200ml daily of urine). It will be a simple randomization, to asses the effect of combined hydrochlorothiazide-furosemide therapy After a of 15 days washout without diuretic treatment, patients will be randomized to receive or not receive combined diuretic treatment for 1 month. After a 1 month washout , the patients will be receive or not the treatment according to cross over trial.