clinical trials for the WAK
Our WAK has completed bench, animal and 2 feasibility human trials. As we prepare for further clinical human trials all suggestions and ideas for the design of those trials are welcome
Browse Ideas with tag 'esrd':
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This idea is active.ESRD/DIALYSIS »1 comment for Idea: clinical trials for the WAK
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Perioperative optimisation of CKD patients
CKD is associated with major cardiovascular alterations, nutritional impairment, and functional decline. A very significant number of ESRD/CKD patients undergo major surgery, and are at increased risk of postoperative complications. Perioperative haemodynamic optimisation protocols have been beneficial in some patient settings but often exclude these patients. We need to understand whether a protocol of functional assessment, ...more »
Add your comment for Idea: Perioperative optimisation of CKD patientsCKD is associated with major cardiovascular alterations, nutritional impairment, and functional decline. A very significant number of ESRD/CKD patients undergo major surgery, and are at increased risk of postoperative complications. Perioperative haemodynamic optimisation protocols have been beneficial in some patient settings but often exclude these patients. We need to understand whether a protocol of functional assessment, haemodynamic optimisation, and attention to microvascular perfusion can improve outcomes in this population.
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This idea is active.ESRD/DIALYSIS »
Quality or Life
2 comments for Idea: Quality or LifeThe Rand KDQOL-SF currently used in dialysis units is onerous to use. It comprises 78 questions, is difficult to administer and to take. Furthermore, there seems to be differences in what populations gauge as quality of life changes and what patients actually report in clinical settings. Herein lies an opportunity to update and modify patient reporting and quality of life metrics.
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This idea is active.CKD »
Optimizing functioning and health through physical activity
6 comments for Idea: Optimizing functioning and health through physical activityPatients with CKD, regardless of stage, have low functioning and physical activity. How can we effectively and efficiently incorporate physical activity into the routine care of these patients to optimize physical function, overall health and quality of life?
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This idea is active.CKD »
Pain management in CKD
Pain is common and is underrecognized and under-treated in chronic kidney disease (CKD). Often these patients with various co-morbidities undergo operative procedures and require analgesics. The most-responsible physician providing the care to these individuals during their hospitalization is often a non-nephrologist. Opioids are commonly used in the management of both acute and chronic pain, and often a standard dose ...more »
Add your comment for Idea: Pain management in CKDPain is common and is underrecognized and under-treated in chronic kidney disease (CKD). Often these patients with various co-morbidities undergo operative procedures and require analgesics. The most-responsible physician providing the care to these individuals during their hospitalization is often a non-nephrologist. Opioids are commonly used in the management of both acute and chronic pain, and often a standard dose is used by the health-care providers without taking into consideration the kidney function. Prolonged narcotic effects and ventilatory depression due to morphine and other opioids have been known for over a century in patients with kidney failure. The exact incidence is not known but it occurs in over half of the patients with chronic kidney disease. Despite the increased potential for respiratory depression, especially in patients with chronic kidney disease, life-threatening cases of opiate toxicity continue to occur not only in patients with kidney disease but also in patients without kidney disease. It is important to evaluate and highlight the issue of central nervous system (CNS) and respiratory depression with opioid analgesics in patients with chronic kidney disease and then formulate strategies to prevent these complications, while providing effective pain relief.
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Collaborating with Medicare/HHS
The government spends billions of dollars on ESRD care. Large portions of these costs are driven by therapy to conform with opinion-based guidelines. The history of ESA therapy is a glaring example of harmful practice and financial waste. It seems that patient care and biomedical science could benefit with large cost-savings if definitive clinical trials informed clinical practice. The cost may be too great for NIDDK, ...more »
Add your comment for Idea: Collaborating with Medicare/HHSThe government spends billions of dollars on ESRD care. Large portions of these costs are driven by therapy to conform with opinion-based guidelines. The history of ESA therapy is a glaring example of harmful practice and financial waste. It seems that patient care and biomedical science could benefit with large cost-savings if definitive clinical trials informed clinical practice. The cost may be too great for NIDDK, but given the ESRD-related expenditures of Medicare, HHS should view investing in such trials as a financial imperative.
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This idea is active.HYPERTENSION »
Elective allograft nephrectomy & events after failed transplant
Patients who return to dialysis after a failed renal transplant have a markedly increased risk for death and other adverse outcomes. The retained allograft serves as a nidus for excess inflammation that could contribute to cardiovascular and other clinical events. Other than repeat transplant, few effective options exist for reducing the risk of premature mortality. Observational data suggest a possible benefit of allograft ...more »
3 comments for Idea: Elective allograft nephrectomy & events after failed transplantPatients who return to dialysis after a failed renal transplant have a markedly increased risk for death and other adverse outcomes. The retained allograft serves as a nidus for excess inflammation that could contribute to cardiovascular and other clinical events. Other than repeat transplant, few effective options exist for reducing the risk of premature mortality. Observational data suggest a possible benefit of allograft nephrectomy, but those studies are limited by selection bias and potential residual confounding. A randomized controlled trial of elective allograft nephrectomy on the risks of death, other clinically relevant events & resource utilization in patients returning to dialysis after allograft failure would provide the evidence needed to determine whether this would be a therapeutic option for these high-risk patients. Other therapeutic approaches could be layered on to such a trial using a factorial design as well.
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This idea is active.AKI »
miRNAs and Renal Disease
5 comments for Idea: miRNAs and Renal DiseaseIt is becoming clear that miRNAs regulate all aspects of renal disease, and they are 'druggable' targets: the first antagomir human trial is underway in heart. We need to understand which miRNAs are specific to kidney, in what to kidney cell type they are expressed and how they regulate renal disease. This effort should be systematic - with data made available publicly to avoid duplicative effort and funding.
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Syndrome of rapid onset ESRD
We recently described the previously unrecognized syndrome of rapid-onset end-stage renal disease (SORO-ESRD) in a high-risk 100-CKD patient cohort in the September 2010 issue of the journal, Renal Failure. This is the unanticipated and unpredictable accelerated progression from CKD to ESRD following acute medical and surgical events. The majority of the patients who exhibited this syndrome were aged >65 years old. The ...more »
Add your comment for Idea: Syndrome of rapid onset ESRDWe recently described the previously unrecognized syndrome of rapid-onset end-stage renal disease (SORO-ESRD) in a high-risk 100-CKD patient cohort in the September 2010 issue of the journal, Renal Failure. This is the unanticipated and unpredictable accelerated progression from CKD to ESRD following acute medical and surgical events. The majority of the patients who exhibited this syndrome were aged >65 years old. The US population is an aging one. The prevalence of this new unrecognized syndrome in the general US ESRD population and the predilection of the aging US population calls for further study. The impact of the findings on AV Fistula First programs, on reno-protection strategies in general and the whole neglected area of preventative nephrology especially as it pertains to the aging baby boomers may be most significant and could call for paradigm shifts in current standards of practice and care of older (>65 year old) CKD patients.
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Dialysis Patients with Marked Improvement in LVEF
I have noticed over the last few years some of our extremely ill dialysis patients with severe CHF/cardiomyopathy with an LVEF (10 - 20%) have shown marked improvement in LVEF (40 - 60%) without surgical intervention (CABG, stint placement, valve replacement. etc.) Some of the cardiologists have attributed this to Coreg, but are they overlooking other meds like ARBS or others? Has anyone else seen this in their patients? ...more »
1 comment for Idea: Dialysis Patients with Marked Improvement in LVEFI have noticed over the last few years some of our extremely ill dialysis patients with severe CHF/cardiomyopathy with an LVEF (10 - 20%) have shown marked improvement in LVEF (40 - 60%) without surgical intervention (CABG, stint placement, valve replacement. etc.) Some of the cardiologists have attributed this to Coreg, but are they overlooking other meds like ARBS or others? Has anyone else seen this in their patients? Any thoughts on why this could be occurring?
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Uremia: What are we treating ? Does size of molecules matter?
Three types of uremic retention solutes have been described using a classification based on characteristics that influence their dialysis clearance: small water-soluble compounds, protein-bound compounds, and middle-molecules. Small water-soluble compounds are easily removed by diffusion and have an upper molecular weight of 500 D. Protein-bound solutes are hydrophobic compounds that bind to proteins, most commonly albumin. ...more »
1 comment for Idea: Uremia: What are we treating ? Does size of molecules matter?Three types of uremic retention solutes have been described using a classification based on characteristics that influence their dialysis clearance: small water-soluble compounds, protein-bound compounds, and middle-molecules. Small water-soluble compounds are easily removed by diffusion and have an upper molecular weight of 500 D. Protein-bound solutes are hydrophobic compounds that bind to proteins, most commonly albumin. . Middle molecules have a molecular weight higher than 500 D and the classic middle molecule has been beta2-microglobulin and β2M was the middle molecule marker used in the HEMO Study. Substances with lower molecular masses may behave as MM’s because of steric configurations, electric charge, hydrophobicity, or binding to plasma proteins. The recently completed FHN study did not directly address what solute is critical to improving outcomes since volume, phosphate, and small molecule clearance would be improved by daily dialysis. What are we treating with dialysis? What should be the targets of therapy or the marker of adequate dialysis? If we are going to have artificial kidneys, what should these kidneys remove? Does middle molecule clearance matter? It seems to me that a great deal of work is done by the EuTox group in describing more and more potential toxins, but there is little clarity on what we are treating with dialysis.
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Renal Palliative Care
This year, 85,000 Americans with end-stage renal disease (ESRD) will die and legitimate questions will be raised as to whether unnecessarily aggressive and expensive treatments were or were not provided, whether patient quality of living/dying could have been improved, and why most hemodialysis deaths take place in institutional settings where a majority of individuals suffer distressing end-of-life symptoms. All of ...more »
3 comments for Idea: Renal Palliative CareThis year, 85,000 Americans with end-stage renal disease (ESRD) will die and legitimate questions will be raised as to whether unnecessarily aggressive and expensive treatments were or were not provided, whether patient quality of living/dying could have been improved, and why most hemodialysis deaths take place in institutional settings where a majority of individuals suffer distressing end-of-life symptoms. All of these issues are linked to a the failure to plan for death using available palliative care and hospice services. The rate of hospice use among patients dying with ESRD is half that of the national average and one-quarter the rate for patients with terminal cancer. The importance of addressing end-of-life issues in HD patients is underscored by rapid growth in spending since ESRD patients constitute only 1.5% of the Medicare population but consume 10% of its budget. Greater use of hospice by HD patients can improve the quality of care while simultaneously lowering costs.
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This idea is active.CKD »
BURNT-OUT DIABETES IN CKD
Treatment of early diabetes mellitus, the most common cause of chronic kidney disease (CKD), may prevent or slow the progression of diabetic nephropathy and lower mortality and the incidence of cardiovascular disease in the general population and in patients with early stages of CKD. It is unclear if glycemic control in patients with advanced CKD, including those with end-stage renal disease (ESRD) who undergo maintenance ...more »
Add your comment for Idea: BURNT-OUT DIABETES IN CKDTreatment of early diabetes mellitus, the most common cause of chronic kidney disease (CKD), may prevent or slow the progression of diabetic nephropathy and lower mortality and the incidence of cardiovascular disease in the general population and in patients with early stages of CKD. It is unclear if glycemic control in patients with advanced CKD, including those with end-stage renal disease (ESRD) who undergo maintenance dialysis treatment is beneficial. Aside from the uncertain benefits of treatment in ESRD, hypoglycemic interventions in this population are also complicated by the complex changes in glucose homeostasis related to decreased kidney function and to dialytic therapies, which may occasionally lead to spontaneous resolution of hyperglycemia and normalization of hemoglobin A1c levels, with a resultant picture of “burnt-out diabetes”. Further difficulties in ESRD are posed by the complicated pharmacokinetics of antidiabetic medications and the serious flaws in our available diagnostic tools used for monitoring long term glycemic control. Studies are needed ti examine the physiology and pathophysiology of glucose homeostasis in advanced CKD and ESRD, the available antidiabetic medications and their specifics related to kidney function, and the diagnostic tools used to monitor the severity of hyperglycemia and the therapeutic effects of available treatments, along with their deficiencies in ESRD. Studies need to investigate the concept of burnt-out diabetes and summarize the findings of studies that examined outcomes related to glycemic control in diabetic ESRD patients
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Racial Survival Disparities within Dialysis Populations
There are counterintuitive but consistent observations that African Americans maintenance dialysis patients have greater survival despite their less favorable socioeconomic status, high burden of cardiovascular risks including hypertension and diabetes, and excessively high chronic kidney disease prevalence. The fact that such individuals have a number of risk factors for lower survival and yet live longer when undergoing ...more »
Add your comment for Idea: Racial Survival Disparities within Dialysis PopulationsThere are counterintuitive but consistent observations that African Americans maintenance dialysis patients have greater survival despite their less favorable socioeconomic status, high burden of cardiovascular risks including hypertension and diabetes, and excessively high chronic kidney disease prevalence. The fact that such individuals have a number of risk factors for lower survival and yet live longer when undergoing dialysis treatment is puzzling. Similar findings have been made among Israeli maintenance dialysis patients, in that those who are ethnically Arab have higher end-stage renal disease but exhibit greater survival than Jewish Israelis. The juxtaposition of these two situations may provide valuable insights into racial/ethnic based mechanisms of survival in chronic diseases. Survival advantages of African American dialysis patients may be explained by differences in nutritional status, inflammatory profile, dietary intake habits, body composition, bone and mineral disorders, mental health and coping status, dialysis treatment differences, and genetic differences among other factors. Prospective studies are needed to examine similar models in other countries and to investigate the potential causes of these paradoxes in these societies. Better understanding the roots of racial/ethnic survival differences may help improve outcomes in both chronic kidney disease patients and other individuals with chronic disease states
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This idea is active.TRANSPLANTATION »
Increasing the Supply of Transplantable Cadaveric Kidneys
A major limitation to expanding donor criteria for procurement of cadaveric renal allografts is our continued reliance on the use of hypothermic preservation. Cold preservation limits the warm ischemic times to recover kidneys to less than 60-minutes post-cardiac arrest. In the era of molecular biology and proteomics, hypothermic preservation - a 60-year old technology can be thought of as the "ice age". Technologies ...more »
9 comments for Idea: Increasing the Supply of Transplantable Cadaveric KidneysA major limitation to expanding donor criteria for procurement of cadaveric renal allografts is our continued reliance on the use of hypothermic preservation. Cold preservation limits the warm ischemic times to recover kidneys to less than 60-minutes post-cardiac arrest. In the era of molecular biology and proteomics, hypothermic preservation - a 60-year old technology can be thought of as the "ice age". Technologies such as effective prospective evaluations of viability and function, treatments to repair damage to the cytoskeleton, prevention of reperfusion injury, etc. could impact the ability to procure increased numbers of warm ischemically damaged kidneys. Rather than fabricating a 3-trillion cell construct containing stem cells that must differentiate into the heterogeneous cells required for renal function, as a first step why not attempt to replace the several million acutely damaged renal cells in an ischemically damaged allograft with human progenitor cells.
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Should LDOs become ACOs for ESRD care?
2 comments for Idea: Should LDOs become ACOs for ESRD care?What are the implications for costs, quality and access to care if large dialysis organizations become Accountable Care Organizations for ESRD patients?
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This idea is active.ESRD/DIALYSIS »
Vitamin D and mortality among ESRD patients
3 comments for Idea: Vitamin D and mortality among ESRD patientsDoes vitamin D supplementation reduce the risk of mortality among ESRD patients. A RCT
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Risk factors for delayed translation of EBM care for CKD
1 comment for Idea: Risk factors for delayed translation of EBM care for CKDAre there modifiable risk factors associated with facility-to-facility variations in care of ESRD patients?
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Technology for self-care dialysis
Expansion of the existing ESRD system to accomodate intensive dialysis for many or most patients will require widespread self-care home hemodialysis. There is a need to make that process easier for patients to accept, and that probably means changing the devices we prescribe and they use. Needs include devices to promote self-cannulation, prevent/detect accidental disconnect, improved water supply and ways to reduce ...more »
5 comments for Idea: Technology for self-care dialysisExpansion of the existing ESRD system to accomodate intensive dialysis for many or most patients will require widespread self-care home hemodialysis. There is a need to make that process easier for patients to accept, and that probably means changing the devices we prescribe and they use.
Needs include devices to promote self-cannulation, prevent/detect accidental disconnect, improved water supply and ways to reduce the complexity of therapy.
Additional involvement by the research community might derisk programs to being new devices to market for home hemo, and in so doing, encourage all stakeholders - academia, inventors, practitioners, and most importantly, industry to work towards facilitating home intensive dialysis.
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This idea is active.AKI »
What are Determinants of Recovery of Kidney Function after AKI?
Many patients who sustain an episode of AKI either have no recovery of kidney function and remain dialysis dependent or have only partial recovery of kidney function. Epidemiologic studies have demonstrated that patients who survive an episode of AKI are at increased risk for development of progressive CKD or ESRD. What factors determine recovery of kidney function after an episode of AKI? Are any of these factors ...more »
3 comments for Idea: What are Determinants of Recovery of Kidney Function after AKI?Many patients who sustain an episode of AKI either have no recovery of kidney function and remain dialysis dependent or have only partial recovery of kidney function. Epidemiologic studies have demonstrated that patients who survive an episode of AKI are at increased risk for development of progressive CKD or ESRD.
What factors determine recovery of kidney function after an episode of AKI?
Are any of these factors modifiable?
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This idea is active.DIABETIC NEPHROPATHY »
What next after RAAS blockade?
11 comments for Idea: What next after RAAS blockade?At the current time, we only have RAAS blockade and hypertension control to slow progression to ESRD. What mechanisms should be targeted to slow progression (loss of GFR) in diabetic nephropathy?
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This idea is active.HYPERTENSION »
Labile hypertension
1 comment for Idea: Labile hypertensionSubstantial fluctuations in blood pressure within an individual are not uncommon. Yet the definition, implications on clinical outcomes, pathogenesis and management are unclear. This would be an important and challenging area for translational and clinical research and later basic research.