We discovered a new modality that will allow us to effectively remove excess fluid from patients and manage hypervolemia. Accordingly, we propose the development of a simple, safe miniature portable device that can slowly remove sufficient excess fluid, on a continuous basis, from patients with congestive heart failure (CHF). During this two-year Phase I study, we will design and develop this new fluid removal process, and define the design requirements for the miniaturized device, which will include a replaceable component. This replaceable component will be designed and evaluated in an in vitro testing circuit. Measurement of inflammatory mediators and clotting factors will be made, along with the continuous monitoring of blood flow rate, and associated pressures at several points in the circuit will be made. Given that there are no such portable devices available for clinical use, this device will have strong potential for improving survival and for decreasing costs for patients with recalcitrant congestive heart failure. Aside from the implied benefit of controlling congestive heart failure and potentially reducing left ventricular hypertrophy (LVH), a major cause of morbidity and mortality in dialysis patients, this device would be expected to dramatically reduce the excess, repetitive hospitalizations commonly incurred by dialysis patients who suffer from fluid overload and pulmonary edema. Reducing the number of these emergency hospitalizations would undoubtedly be a major cost savings for the Medicare-funded End Stage Renal Disease (ESRD) and CHF treatments. , ,
Public Health Relevance: This proposal addresses the development of a portable hemofiltration device which can be attached to a central venous catheter for the purpose of providing slow, continuous fluid removal for the maintenance of fluid balance in patients on chronic dialysis. This device would have the most value for those dialysis patients who are having difficulty in controlling blood pressure, fluid retention and pulmonary edema. The proposed design is appealing, with the utilization of a replaceable filtration unit which can be easily attached to a propulsion unit with miniature pumps for propelling blood through a hemofilter. This design could easily allow for slow, continuous fluid removal (1-3 ml/min) throughout the interdialytic period, allowing dialysis patients to avoid fluid overload. Aside from the implied benefit of controlling congestive heart failure and potentially reducing left ventricular hypertrophy (LVH), a major cause of morbidity and mortality in dialysis patients, this device would be expected to dramatically reduce the excess, repetitive hospitalizations commonly incurred by dialysis patients who suffer from fluid overload and pulmonary edema. Reducing the number of these emergency hospitalizations would undoubtedly be a major cost savings for the Medicare-funded End Stage Renal Disease (ESRD) program. This device could also be used for the management of congestive heart failure (CHF) in patients who are not on dialysis but in whom emergency admissions for pulmonary edema are a common occurrence.
Thesaurus Terms: Abscission;Address;Admission;Admission Activity;Algorithms;American;Artificial Membranes;Bp Control;Blood;Blood Circulation;Blood Coagulation Factor;Blood Pressure, High;Blood Flow;Bloodstream;Cardiac Failure Congestive;Cardiovascular;Cardiovascular Body System;Cardiovascular Diseases;Cardiovascular System;Cardiovascular System (All Sites);Catheters;Cessation Of Life;Chronic;Chronic Kidney Failure;Chronic Renal Disease;Circulation;Clinical;Clotting;Coagulation;Coagulation Factors;Coagulation Process;Collection;Complement Activation;Congestive Heart Failure;Corrosion;Corrosions;Cost Savings;Data;Data Set;Dataset;Death;Development;Device Designs;Devices;Dialysis;Dialysis Patients;Dialysis Procedure;Documentation;Drops;Esrd;Early Diagnosis;Emergencies;Emergency Situation;End Stage Renal Failure;End-Stage Kidney Disease;Evaluation;Excision;Extirpation;Filtration;Fluid Balance;Fluid Overload;Foundations;Fractionation, Filtration;Funding;Glomerular Filtration Rate;Goals;Grafting, Kidney;Hosp;Health Care Providers;Health Insurance For Aged And Disabled, Title 18;Health Insurance For Aged, Title 18;Health Insurance For Disabled Title 18;Health Personnel;Healthcare Providers;Healthcare Worker;Heart Decompensation;Heart Failure, Congestive;Hemodialyses;Hemodialysis;Hemofiltration;Home;Home Environment;Hospitalization;Hospitals;Hour;Housing;Hypertension;Individual;Inflammation Mediators;Inflammatory;Kidney;Kidney Diseases;Kidney Failure;Kidney Failure, Chronic;Kidney Insufficiency;Kidney Replacement Therapy;Kidney Transplantation;Kidney Transplants;Laboratories;Left Ventricular Hypertrophy;Leg;Life;Liquid Substance;Maintenance;Maintenances;Measurement;Medical Device;Medicare;Membrane;Minority;Modality;Monitor;Morbidity;Morbidity - Disease Rate;Mortality;Mortality Vital Statistics;Nhanes;National Health And Nutrition Examination Survey;Nephropathy;Organ System, Cardiovascular;Patients;Phase;Physicians;Population;Power Sources;Power Supplies;Pressure;Pressure- Physical Agent;Process;Programs (Pt);Programs [publication Type];Publications;Pulmonary Edema;Pump;Reaction;Removal;Renal Disease;Renal Disease, End-Stage;Renal Failure;Renal Failure, Chronic;Renal Insufficiency;Renal Replacement Therapy;Renal Transplantation;Renal Transplants;Reporting;Reticuloendothelial System, Blood;Risk;Safety;Saving, Cost;Scientific Publication;Simulate;Staging;Surgical Removal;System;System, Loinc Axis 4;Testing;Time;Title 18;To Specify;Ultrafiltration;Urinary System, Kidney;Vascular Hypertensive Disease;Vascular Hypertensive Disorder;Vascular, Heart;Venous;Base;Blood Pressure Control;Blood Pressure Homeostasis;Blood Pressure Regulation;Cardiovascular Disorder;Chronic Kidney Disease;Circulatory System;Clotting Factor;Complement Pathway Regulation;Cost;Cytokine;Data Acquisition;Design;Designing;Dialysis Therapy;Early Detection;Fluid;Health Care Personnel;Health Care Worker;Health Insurance For Disabled;Health Provider;Healthcare Personnel;Hyperpiesia;Hyperpiesis;Hypertensive Disease;Hypervolemia;Improved;In Vitro Testing;Innovate;Innovation;Innovative;Kidney Disorder;Liquid;Lung Edema;Medical Personnel;Meetings;Membrane Structure;Miniaturize;Novel;Operation;Phase 1 Study;Phase 2 Study;Pressure;Programs;Prototype;Public Health Relevance;Renal;Renal Disorder;Resection;Treatment Provider;User-Friendly
