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Renal Insufficiency clinical trials

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NCT ID: NCT03232515 Completed - Blood Pressure Clinical Trials

The Use of Electrical Bioimpedance to Evaluate Dry Weight in Patients With Chronic Renal Failure in Hemodialysis

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

INTRODUCTION: Accurate estimation of dry weight (DW) is an important and difficult problem in clinical practice. DW is defined as the lowest weight after hemodialysis (HD) where the patient will not develop symptoms of hypotension and edema, in addition to not using antihypertensives. Achieving a fluid balance benefits the control of blood pressure and reduces cardiovascular risk. In most HD centers, the DW is estimated using a subjective method dependent on the signs and symptoms that the patient presents. Recently, several approaches have been studied to develop a standardized DW evaluation technique. Among these, the analysis of electric bioimpedance vectors (BIVA) has been recognized as a simple and promising method with high reproducibility. OBJECTIVE: To use BIVA to improve dry weight estimation in patients with chronic renal failure undergoing hemodialysis. Methods: This is a non-randomized pre-test / post-test clinical trial, where the universe of patients comes from the hemodialysis unit of the General State Hospital of Sonora. Patients who have limb amputations, pacemakers, metal implants, who are under renal transplant protocol or who have a renal transplant, and presence of infectious foci will be restricted from participating. The diagnosis of DW in the patients will be performed for modification and follow-up. Fluid status will be evaluated using BIVA. Measurements will be made before and after HD in three consecutive weekly periods and one one final assessment at three months. At the beginning of each period, weight, electrolytes, creatinine, total proteins, albumin, pre-albumin, urea and blood pressure will be measured to calculate the Malnutrition Inflammation Score and Bilbrey Index. At the end of the HD protocol of each period, body composition and muscle strength will be evaluated through triceps skinfold, mid-upper arm circumference and dynamometry. The dialysis dose received will be modified according to BIVA. The main variables to be considered will be DW, extracellular water and blood pressure. The duration of the study will be approximately 6 months. In addition, at the end of each measurement, each participant will be given a nutritional recommendation (feeding guide) specific to their energy requirements.

NCT ID: NCT03211962 Completed - Heart Failure Clinical Trials

Can Urinary Concentrations of TIMP2 and IGFBP7 be Used to Predict Early Acute Renal Failure Following Cardiac Arrest?

ACR-CHECK
Start date: February 1, 2017
Phase:
Study type: Observational

Transient renal insufficiency is frequently observed in the course of cardiovascular arrest. Although elevation of creatinine is reversible in a large majority of cases, severe renal insufficiency is sometimes observed and is associated with a dark prognosis. Any intervention that may limit the worsening of renal function may have an impact on patient mortality. There is currently no validated pharmacological treatment to limit the progression of ARI or to accelerate its recovery. A major challenge then concerns the detection of the reversible character of renal damage. Renal biomarkers have been little studied in the prediction of severe ARI and mortality after cardiac arrest. The combination of TIMP2 (tissue inhibitor of metalloproteinase) and insulin-like growth factor binding protein (IGFBP7) in urine showed good diagnostic performance in the early detection of the risk of developing acute renal failure within 12 hours. Measured in the urine, the excretion of these two markers specifically reflects renal tubular lesions. Moreover, their rate seems to be strongly correlated with the severity of the tubular lesions. Thus, it can be reasonably assumed that their very early dosing in post-cardiac arrest could detect the presence and severity of renal tubular lesions. A threshold to be defined would discriminate patients at risk of developing an ARI within 48 hours post ACR and to distinguish between severe transient and severe persistent lesions beyond 72 hours.

NCT ID: NCT03202212 Completed - Clinical trials for Chronic Kidney Failure

Effect of Mixed On-line Hemodiafiltration on Circulating Markers of Inflammation and Vascular Dysfunction

Start date: February 3, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

On line haemodiafiltration (OL-HDF) has been shown to improve intra-dialytic hemodynamics and cardiovascular outcomes. Several potential candidates of these beneficial effects have been explored. The aim of this study was to investigate the impact of mixed OL-HDF (mOL-HDF) on different circulating mediators of vascular dysfunction.

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: NCT03192111 Completed - Healthy Volunteer Clinical Trials

A Study to Evaluate the Pharmacokinetics of Entinostat in Adult Subjects With Normal and Impaired Renal Function

Start date: July 27, 2017
Phase: Phase 1
Study type: Interventional

This purpose of this study is to evaluate the effects of a single dose of entinostat on subjects with varying levels of renal impairment. The primary objective of this study is to evaluate the pharmacokinetics of a single dose of entinostat in adult subjects with mild, moderate and severe renal impairment compared to healthy mean-matched subjects. The secondary objective of this study is to evaluate the safety and tolerability of entinostat in adult subjects with mild, moderate, and severe renal impairment and in healthy mean-matched adult subjects.

NCT ID: NCT03189498 Completed - Renal Insufficiency Clinical Trials

A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64041575 in Adult Participants With Various Degrees of Renal Function

Start date: July 11, 2017
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to evaluate the pharmacokinetic (PK) and systemic exposure of JNJ-63549109 and JNJ-64167896 after a single oral dose of JNJ-64041575 in adult participants with various degrees of renal function (mildly, moderately, or severely impaired, or end-stage renal disease [ESRD] with or without hemodialysis) compared to adult participants with normal renal function.

NCT ID: NCT03186495 Completed - Clinical trials for Adult Growth Hormone Deficiency

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

Start date: June 20, 2017
Phase: Phase 1
Study type: Interventional

The trial is conducted in Europe. The aim of the trial is to investigate the steady state exposure of somapacitan in subjects with various degrees of renal impairment (mild, moderate, severe renal impairment, requiring haemodialysis treatment) compared to subjects with normal renal function

NCT ID: NCT03172884 Completed - Clinical trials for Hepatic Insufficiency, Renal Insufficiency

Study of Copanlisib in Hepatic or Renal Impairment

Start date: June 14, 2017
Phase: Phase 1
Study type: Interventional

To evaluate the pharmacokinetics and safety of copanlisib in subjects with impaired hepatic or renal function in comparison to healthy subjects

NCT ID: NCT03172039 Completed - Clinical trials for Infection, Bacterial

Antimicrobial Use and Stewardship in an Outpatient Hemodialysis Unit

Start date: May 12, 2017
Phase: N/A
Study type: Observational

This quality improvement study will assess the antimicrobial use and prescribing practices of hospital and community prescribers for the ambulatory hemodialysis (HD) population in an urban academic outpatient HD unit in Ontario. Currently, in the outpatient HD unit at Toronto General Hospital (TGH), it is the standard of care for the patients to be screened on a weekly basis by the nephrology care team for the use of any oral or intravenous antimicrobials. Patient charts, pharmacy patient profiles and electronic medical records for these patients from September 1 2016 - April 30 2017 will be retrospectively reviewed in order to characterize antimicrobial use and its concordance with available clinical guidelines and antimicrobial stewardship principles described by the Centers for Disease Control and Prevention (CDC). The primary objective of the study is to determine the prevalence of antimicrobial use in an ambulatory HD population. The secondary objective of the study is to determine the congruence of prescribed antimicrobial regimens with available clinical guidelines and antimicrobial stewardship principles described by the CDC. It is hypothesized that antimicrobial use among HD patients will be common and that antimicrobial prescribing practices are not congruent with recommendations from published clinical guidelines and antimicrobial stewardship principles for a significant proportion of patients included in the retrospective review. Descriptive analysis of the data will summarize the findings. Future research will build upon the results of this project, and may include the development of interventions that target gaps in knowledge and prescribing behaviours of prescribers who provide care to the ambulatory HD population.

NCT ID: NCT03165071 Completed - Healthy Subjects Clinical Trials

A Study to Evaluate ACT-132577 in Healthy Subjects and in People With Severe Kidney Disease

Start date: June 3, 2017
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to investigate the fate of ACT-132577 in healthy subjects and in people with severe kidney disease