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Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration in Hemodialysis Patients

使用透析中血压斜率指导血液透析患者超滤

基本信息

批准号：
10655325
负责人：
Peter Noel Van Buren
金额：
--
依托单位：
VA NORTH TEXAS HEALTH CARE SYSTEM
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-07-01 至 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10655325
关键词：
Achievement Acute Address Adverse event Affect Algorithms Assessment tool Blood Pressure Blood Vessels Body Fluids Body Weight Cardiac Cardiac Output Cardiovascular Diseases Cardiovascular system Caring Chest Chronic Clinical Clinical Management Clinical Trials Cross-Sectional Studies Dangerousness Data Death Rate Dialysis procedure Echocardiography Eligibility Determination End stage renal failure Enrollment Equilibrium Excision Exclusion Criteria Expenditure Fluid overload Frequencies Functional disorder Future General Population Goals Guidelines Hemodialysis Hospitalization Hour Hypotension Impairment Intervention Kidney Diseases Kidney Failure Left Ventricular Ejection Fraction Left Ventricular Mass Linear Models Liquid substance Maintenance Measurement Measures Methods Monitor Morbidity - disease rate Multicenter Trials Myocardial dysfunction Outcome Outcome Assessment Patients Pattern Peripheral Resistance Phenotype Physiology Population Practice Management Prevalence Randomized Controlled Clinical Trials Research Residual state Risk Risk Factors Safety Spectrum Analysis Structure Symptoms Testing Ultrafiltration United States Update Veterans blood pressure reduction clinical care clinical practice comparison group cost design extracellular follow-up heart function hemodynamics high risk hypertensive improved indexing individual patient innovation intervention effect mortality mortality risk novel patient population personalized approach primary outcome prospective randomized trial recruit routine practice standard care tool

项目摘要

United States Veterans have disproportionately higher risk for end stage renal disease (ESRD) compared to the general population. Veterans with ESRD on maintenance hemodialysis (HD) suffer from alarmingly high mortality rates and hospitalizations mainly related to cardiovascular disease. Extracellular volume (ECV) excess is a primary contributing factor to cardiovascular disease and the heightened mortality rate in HD patients. Extracellular volume excess remains difficult to identify in clinical practice, and the standard approach to fluid management in the clinical setting involves arbitrary trial and error attempts to remove fluid without invoking hemodynamic instability such as intradialytic hypotension. Bioimpedance spectroscopy (BIS) is a useful research tool for assessing ECV; however, it is not feasible in routine practice, and there is little data on how its use affects intermediate and hard clinical outcomes. There is an unmet need for an approach to guide ultrafiltration in clinical practice that addresses both reduction of ECV and other mortality outcomes as well as minimization of intradialytic hypotension. The long-term goal of this study is to develop a more precise, patient-specific fluid management approach to be tested in a large clinical trial aimed at reducing mortality in Veterans on HD. The overall objective of this project is to utilize our novel, patient-specific ultrafiltration algorithm as an intervention in a clinical trial using mortality risk factors as the primary outcomes. The central hypothesis is that prescribing ultrafiltration prospectively based on an individual patient’s intradialytic blood pressure slopes (IBPS) from recent treatments is superior to standard care at reducing ambulatory blood pressure and ECV without increasing risk for intradialytic hypotension. Aim 1 will use an un-blinded, controlled randomized clinical trial to demonstrate the effects of an IBPS-based ultrafiltration prescription compared to standard clinical practice. Each month, updated ultrafiltration prescriptions for the IBPS group will be determined based on the most recent treatment data. The primary outcome will be change in mean systolic 44-hour ambulatory blood pressure after 4 months. Other outcomes will include 1) change in post-HD ECV/body weight using multifrequency bioimpedance spectroscopy, 2) change in post-HD total peripheral resistance index using a non-invasive cardiac output monitor, and 3) between-group comparison of the frequency of intradialytic hypotension and intradialytic symptoms. Aim 2 will involve a cross sectional analysis of baseline data of subjects from Aim 1 in addition to consecutive enrollment of additional hypertensive HD patients. In addition to Aim 1 measurements, subjects will undergo transthoracic echocardiograms on a non- HD day to obtain measurements of left ventricular ejection fraction as a metric of systolic function, mitral inflow and mitral annulus velocities as a metric of diastolic function, and left ventricular mass index. Mixed linear models will be used to determine how these metrics independently influence the association between ECV/body weight and IBPS. The strength of the association between IBPS and ECV/body weight will then be determined within each tertile of the distributions of systolic and diastolic dysfunction. Finally, there will be an assessment of how the echocardiogram based metrics influence the likelihood of intradialytic hypotension with prospective follow up while controlling for ECV/body weight. If successful, this study will provide nephrologists with an easily-implemented, individualized approach to fluid management in Veterans on HD that safely reduces ECV excess and related mortality risk factors. Because no approach currently exits, this could immediately change clinical practice of managing Veterans with ESRD. The long term impact will be the opportunity to utilize the data generated to design a large, multi-center trial directly evaluating this intervention’s effect on mortality in Veterans with ESRD on HD. The observed reduction in blood pressure can be used to determine expected mortality, while the echocardiogram data can be used to determine phenotypes of patients that may need to be considered for inclusion/exclusion criteria.

美国退伍军人患终末期肾病（ESRD）的风险不成比例地高

项目成果

期刊论文数量（6）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Experimental study and new three-dimensional kinetic modeling of foamy solution-gas drive processes.

DOI：
10.1038/s41598-018-22669-z
发表时间：
2018-03-12
期刊：
Scientific reports
影响因子：
4.6
作者：
Sun X;Zhang Y;Wang S;Song Z;Li P;Wang C
通讯作者：
Wang C

Correlation between hammerhead ribozyme-mediated eggshell protein gene cleavage and reproduction inhibition of Schistosoma japonicum.

DOI：
10.3892/mmr.2012.752
发表时间：
2012-04
期刊：
Molecular medicine reports
影响因子：
3.4
作者：
Liang Y;Zhou Y;Yin W;Li Y;Yang Q;Gao Y;Zhang Y;Yang Y;Peng L;Xiao J
通讯作者：
Xiao J

Hyperphosphatemia and its relationship with blood pressure, vasoconstriction, and endothelial cell dysfunction in hypertensive hemodialysis patients.

DOI：
10.1186/s12882-022-02918-0
发表时间：
2022-08-23
期刊：
BMC NEPHROLOGY
影响因子：
2.3
作者：
Jung, Jinwoo;Jeon-Slaughter, Haekyung;Hang Nguyen;Patel, Jiten;Sambandam, Kamalanathan K.;Shastri, Shani;Van Buren, Peter Noel
通讯作者：
Van Buren, Peter Noel

The associations between orthostatic blood pressure changes and extracellular volume in hemodialysis patients.