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Kidney Failure, Chronic clinical trials

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NCT ID: NCT01191905 Completed - Sepsis Clinical Trials

Effects of HIgh Volume COntinuous REnal Replacement Therapy in Patients With Septic Acute Kidney Injury

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

Acute kidney injury (AKI) is a common and serious problem in critically ill patients, and is known to be an independent risk factor for mortality. Among the various etiologies of AKI, sepsis or septic shock is the most frequent contributing factor especially in an intensive care unit setting. Also, the mortality of septic AKI in these patients still remains extremely high despite recent marked therapeutic advance. Given the physiologic superiority of continuous renal replacement therapy (CRRT) on uremia and volume control, it has become the modality of choice in critically ill patients with AKI. In addition, CRRT can theoretically provide immunohomeostasis through the convective and adsorptive removal of various immune mediators. Although the pathophysiology of septic AKI remains elusive, it has become increasingly recognized that many pro- and anti-inflammatory mediators, such as TNF, IL-6, IL-8 and IL-10, play an important role in this process. Therefore, it has been speculated that the reduction of cytokines by increasing CRRT dose in patients with septic AKI may reduce mortality risk. Even though recent two large scale randomized controlled trials, ATN and RENAL study, have failed to show the difference in survival rate between the clearance of 20~25 ml/kg/hr and 35~40 ml/kg/hr, none of these studies were designed to elucidate the survival benefit of high intensity CRRT in patients with septic AKI. Moreover, the optimal target CRRT dose in these patients is not well established and may be even higher than 35~40 ml/kg/hr in terms of septic AKI. Indeed, recent several uncontrolled trial have shown the survival benefit of high intensity CRRT in these patients. To further explore the effects of high dose CRRT on survival of critically ill patients with septic AKI, the investigators will conduct a multicenter prospective randomized controlled open-label trial which compares the difference in survival rate between 1:1 balanced pre-dilution CVVHDF at 80 vs. 40 mL/Kg/hr for initial 72hrs after the start of CRRT. The primary end-point of this study is the effect of high volume pre-dilution CVVHDF on 28-day survival rate. The secondary end-point is 60- and 90-day mortality, ICU and in-hospital mortality, duration of CRRT and renal replacement therapy, duration of mechanical ventilation, cytokine removal rate at 12h after the initiation of CRRT, and changes in SOFA and APACHE II score at 72h after the initiation of CRRT. This is a superiority trial which aims to demonstrate a reduction of 20% or more in mortality rate. For this purpose, at least 109 subjects (a total of 218) would be required for each group if type I error rate is 5% and type II error is 20% given 25% of drop-out rate during the study period. Block randomization will be used by means of a dedicated website. There are still conflicting data on the optimal target dose of CRRT in patients with septic AKI. Our study will address this issue to answer the unresolved question on the effect of high dose CRRT.

NCT ID: NCT01191255 Completed - Kidney Failure Clinical Trials

A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis

Start date: October 2010
Phase: Phase 3
Study type: Interventional

This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.

NCT ID: NCT01186276 Completed - Clinical trials for Kidney Failure, Chronic

Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes

Start date: July 2010
Phase: N/A
Study type: Interventional

This study will assess whether dietary fiber supplements can reduce the production of chemicals which are produced by colon bacteria and normally excreted from the body by the kidney, but build up in the body in patients on hemodialysis.

NCT ID: NCT01160978 Completed - Heart Failure Clinical Trials

Donor Simvastatin Treatment in Organ Transplantation

SIMVA
Start date: June 1, 2010
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of the study is to investigate the effects of donor simvastatin treatment on ischemia-reperfusion injury after heart transplantation.

NCT ID: NCT01158742 Completed - Clinical trials for Kidney Transplantation

Live Kidney Donor Study -Renal Function Study

Start date: September 2009
Phase: N/A
Study type: Observational

Kidney transplantation from living donors has been shown to carry many benefits over deceased donor transplantation. Because of benefits such as shorter waiting times and improved outcome for transplant recipients, living kidney donation accounts for an increasing number of kidney transplants nationwide. Most published studies about living kidney donation demonstrate that the procedure is safe, but they also emphasize concerns that long-term data on live donor outcomes are insufficient. In particular, data concerning the extent of renal function decline after donation are inadequate. This study will measure glomerular filtration rate (GFR) in previous living donors and aims to more accurately describe renal function after kidney donation.

NCT ID: NCT01143532 Completed - Clinical trials for Kidney Transplantation

Role of Donor Genetics and Recipient Genetics in Kidney Transplant Outcomes

Start date: August 12, 2010
Phase:
Study type: Observational

Background: - Genetic variation in a particular chromosome is a major contributor to the increased risk for kidney disease that is common in people of African descent, although the specific gene, mutations, and other aspects of the variations remain to be determined. By studying the outcomes of kidney transplant in donors and recipients of African descent, researchers hope to better understand the effects of this genetic variation on the success of kidney transplants. Objectives: - To examine possible connections between genetic variations and kidney transplant outcomes for donors and recipients. Eligibility: - Participants in kidney transplant where both donor and recipient were of black African descent. - Eligible transplants include both living donor and deceased donor. Design: - The study will involve one visit of up to 8 hours. - All participants will provide a detailed personal and family medical history. - All participants will provide blood and urine samples, including a 24-hour urine collection, to test kidney function and collect material for genetic testing. - Donor participants will also have a magnetic resonance imaging (MRI) scan of their remaining kidney.

NCT ID: NCT01134900 Completed - Clinical trials for Kidney Failure, Acute

Achieving Medication Safety During Acute Kidney Injury

Start date: June 2010
Phase: N/A
Study type: Interventional

The utilization of clinical decision support (CDS) is increasing among healthcare facilities which have implemented computerized physician order entry or electronic medical records. Formal prospective evaluation of CDS implementations occurs rarely, and misuse or flaws in system design are often unrecognized. Retrospective review can identify failures but is too late to make critical corrections or initiate redesign efforts. A real-time surveillance dashboard for high-alert medications integrates externalized CDS interactions with relevant medication ordering, administration, and therapeutic monitoring data. The surveillance view of the dashboard displays all currently admitted, eligible patients and provides brief demographics with triggering order, laboratory, and CDS failure data to allow prioritization of high-risk scenarios. The patient detail view displays a detailed timeline of orders, order administrations, laboratory values, and CDS interactions for an individual patient and allows users to understand provider actions and patient condition changes occurring in conjunction with CDS failures. Clinical pharmacists' use of the dashboard for patient monitoring and intervention aims to increase the rate and timeliness of intercepted medication errors compared to CPOE-based CDS in the setting of acute kidney injury, which affects patients at various points across all hospital units and services and has numerous opportunities for intervention.

NCT ID: NCT01125033 Completed - Clinical trials for Kidney Failure, Chronic

Study of Vitamin C, Vitamin E and Their Combination to Treat Restless Legs Syndrome in Hemodialysis Patients

ShirazUMS
Start date: March 2008
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine whether vitamin C, vitamin E and their combination are effective in the treatment of RLS in hemodialysis patients.

NCT ID: NCT01068314 Completed - Clinical trials for Kidney Failure, Chronic

Effect of Exercise on Endothelial Function and Vascular Compliance in Chronic Kidney Disease

Start date: January 2007
Phase: N/A
Study type: Interventional

The study hypothesis is that 6 weeks of repetitive handgrip exercise will improve endothelial function and venous compliance in pre-dialysis patients with an estimated glomerular filtration rate of less than or equal to 20 ml/min. If proven correct then arm exercise might be useful to improve the success rate for a surgically created arteriovenous fistula in the forearm to become usable as a vascular access for hemodialysis.

NCT ID: NCT01021839 Completed - Kidney Failure Clinical Trials

Comparison of Bovine Carotid Artery and Expanded Polytetrafluoroethylene (ePTFE) for Permanent Hemodialysis Access

Start date: April 2006
Phase: N/A
Study type: Interventional

The investigators did a randomized control trial comparing bovine carotid artery grafts with ePTFE grafts for patients that need hemodialysis access. The goal of the study was to determine differences in primary and assisted patency rates and frequency of complications between these two types of grafts. The investigators' hypothesis was that bovine carotid artery grafts more closely mimic autologous tissue and therefore, would provide better patency and fewer complications.