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Kidney Failure, Chronic clinical trials

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NCT ID: NCT03246984 Completed - Kidney Diseases Clinical Trials

VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ

VALUE
Start date: September 7, 2017
Phase: N/A
Study type: Interventional

This is a prospective single arm study enrolling patients who are scheduled for creation of a new Brachiocephalic or Radiocephalic AV fistula. Up to 80 patients will be enrolled, 50 with upper arm AV fistula and 30 with forearm AV fistula. All patients will be implanted with the VasQ device, a subcutaneous arteriovenous conduit support for vascular access. The follow up period in this study will be for a duration of 12 months, with follow up visits scheduled at 1, 3, 6, 9, and 12 months.

NCT ID: NCT03242343 Completed - Diabetes Mellitus Clinical Trials

VasQ External Support for Arteriovenous Fistula

Start date: November 29, 2017
Phase: N/A
Study type: Interventional

This is a prospective clinical study of the VasQ external support for arteriovenous fistulas. The device is designed to improve fistula outcomes by optimizing the geometrical configuration of the fistula, influencing hemodynamics, minimizing turbulence and promote laminar flow. All patients will be implanted with the VasQ device and will be followed up for a duration of 24 months.

NCT ID: NCT03194750 Completed - Respiratory Failure Clinical Trials

Ultrasound Assessment of Volume in Patients on Continuous Dialysis

Start date: June 1, 2016
Phase: N/A
Study type: Interventional

Renal failure and resuscitation measures in critically ill patients can result in fluid overload. Fluid overload in renal failure patients can cause harmful effects like pulmonary edema, anasarca and congestive cardiac failure exacerbations among other complications. These have been associated with increased time on the ventilator, increased length of stay in the ICU, and higher overall mortality for patients requiring dialysis in the ICU. The current standard of care for adjusting fluid removal rates in patients on continuous renal replacement therapy relies on clinical judgement. Clinicians take into account factors like the patient's condition, vasopressor requirements, kidney function, total intake and outputs, vital signs, and physical examination findings when making daily changes to fluid removal rates on dialysis machines. Such assessment is highly subjective and can be imprecise/inaccurate leading to hypotension and hemodynamic instability in a critically ill patient. Use of conventional ultrasound by physicians to assess volume status using compressibility of the inferior vena cava has been shown to be a reliable predictor of volume status and can help guide therapy. Such use makes bedside volume assessment a non-invasive, rapid, repeatable point of care tool that can provide objective data to guide fluid removal determine velocity of fluid removal and help identify patients at risk of hypotension and hemodynamic instability during the process of fluid removal. Apart from rare possible local allergic reactions to ultrasound jelly and transient local discomfort, the disadvantages are minimal. Ultrasonography has been considered a safe imaging modality. This protocol will measure inferior vena cava compressibility using the General Electric VScan with Dual Probe, which has FDA approval for abdominal and vascular imaging in humans.

NCT ID: NCT03189758 Recruiting - Clinical trials for Kidney Failure, Chronic

Dietary Sodium (DS) Intervention to Reduce Volume Overload and Tissue Sodium in Magnetic Resonance Imaging (MRI) for Hemodialysis (HD) Patients

DSMRI
Start date: June 19, 2017
Phase: N/A
Study type: Interventional

Sodium-adapted magnetic resonance imaging (23Na-MRI) studies have demonstrated that sodium accumulates in certain tissues, including the skin and skeletal muscle, but may be manipulated by lifestyle factors or therapeutic interventions such as a hemodialysis (HD) session. This tissue sodium accumulation is increased with age and in the presence of certain chronic diseases such as renal failure, and may contribute to the development of high blood pressure. It currently not known what the impact of dietary sodium consumption has on tissue sodium in HD patient's and on the subsequent risk of cardiovascular complications either acutely or chronically. The University of Illinois' Biomedical Imaging Center recently completed safety testing on a 23Na-MRI coil that they modified for measuring skin and muscle sodium levels in the lower leg/calf that will be used for assessing the impact of dietary salt restriction on tissue sodium levels.

NCT ID: NCT03171545 Enrolling by invitation - Clinical trials for Cardiovascular Diseases

Enhancing the Cardiovascular Safety of Hemodialysis Care (Dialysafe)

Dialysafe
Start date: January 11, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is reduce episodes of intradialytic hypotension, low blood pressure during a hemodialysis session, in patients with End Stage Renal Disease (ESRD). Recruitment will take place on the clinic level rather than the patient level.

NCT ID: NCT03160430 Not yet recruiting - Clinical trials for Kidney Failure, Chronic

A Two-Part Phase 2a Study of RVX000222 in Patients With End-Stage Renal Disease Treated With Hemodialysis

Start date: November 22, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-center, two-part study; Part A and Part B. Part A of the study is an open-label, single-dose pharmacokinetic (PK) evaluation of 100 mg RVX000222 on dialysis and non-dialysis days in eight (8) End Stage Renal Disease (ESRD) patients who receive hemodialysis as standard of care. Part B of the study is a double-blind, placebo-controlled study in up to thirty six (36) ESRD patients receiving hemodialysis using a sequential cross-over design with RVX000222 at a daily oral dose of 100 mg b.i.d. (200 mg per day) or matching placebo in combination with SoC. The primary objective of the study is to evaluate if treatment with RVX000222 in combination with standard of care (SoC) decreases plasma alkaline phosphatase in comparison to placebo and SoC.

NCT ID: NCT03143556 Completed - Clinical trials for Kidney Failure, Chronic

Black Star - Magnetic Stent Removal in Transplant Patients

Start date: May 29, 2017
Phase: N/A
Study type: Interventional

This is a pilot, single-centre, feasibility study to assess the feasibility issues and collect preliminary clinical data for the design of future randomized controlled trial to evaluate the feasibility and patient comfort of magnetic retrieval device removal of ureteral stent in transplant patients.

NCT ID: NCT03099434 Active, not recruiting - Kidney Diseases Clinical Trials

Expanding Live Donor Kidney Transplantation Through Advocacy Training and Social Media

ENGAGE
Start date: April 1, 2017
Phase: N/A
Study type: Interventional

This pilot study will be a clinical trial to test the feasibility and effectiveness of an educational intervention and a mobile health intervention in adults with end stage renal disease (ESRD) who have not yet identified a potential live donor.

NCT ID: NCT03065972 Recruiting - Clinical trials for Chronic Kidney Disease

Hemodialysis in the Elderly (70yrs & Older)

ELDERLY
Start date: January 28, 2016
Phase: N/A
Study type: Interventional

This will be a prospective, single institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing autologous arteriovenous fistula versus hemodialysis access grafts in the elderly. The target sample size will include enrollment of 270 patients over a period of 5 years. The creation of an autologous arteriovenous fistula or placement of a hemodialysis access graft constitutes the two arms of the study.

NCT ID: NCT03046914 Recruiting - Clinical trials for Kidney Failure, Chronic

HLA-B*5801 Screening to Prevent Allopurinol-induced Severe Cutaneous Adverse Reaction

Start date: February 24, 2016
Phase: N/A
Study type: Interventional

Allopurinol-induced severe cutaneous adverse reaction (SCAR) is a rare but fatal condition. Previous reports have reported that HLA-B*5801 is an important genetic risk factor significantly associated with the development of allopurinol-induced SCAR. However, there has been no prospective study to prove the clinical efficacy of a HLA-B*5801 screening before administration of allopurinol in predicting allopurinol-induced SCAR. The purpose of this prospective study is to test our hypothesis that a pre-screening of HLA-B*5801 will significantly reduce the risk of allopurinol-induced SCAR development compared to the historical control.