Volume,Sodium and Blood Pressure Management in HD (VSBP)
2016年7月14日 更新者：Rajiv Saran、University of Michigan
Fluid-Weight, Volume, Sodium, Blood Pressure Management in Hemodialysis by Limiting Intradialytic and Inter-dialytic Exposure to Sodium and Protocol-based Challenge of Post-dialysis Target Weight: A Pilot and Feasibility Trial
The purpose of this study to conduct a pilot, randomized trial in stable HD patients to evaluate the effect of gradual, step-wise reduction of post-hemodialysis target weight, combined with diligent dietary sodium restriction and reduction in dialysate sodium exposure on hydration/volume status and blood pressure (BP) control.
研究概览
地位
完全的
条件
详细说明
Fluid-weight management is critical for dialysis patients 1, 2. Previous clinical trials have not comprehensively addressed the application of a strategy combining both sodium restriction and a progressive, but gradual challenge of post dialysis target weight for BP and fluid-weight management in hemodialysis (HD).
The investigators postulate that a protocolized, stepwise and gradual challenge of post-hemodialysis target weight when combined with diligent dietary sodium restriction <2000mg sodium/day, will lead to better hydration/volume status and BP control in HD patients.
A randomized, two parallel arm trial (n=40) among HD patients is proposed, that compares this comprehensive strategy in one group versus 'usual' HD volume/hydration and BP management in the control group.
The two primary outcomes are change in volume/hydration status (assessed by bioelectrical impedance analysis-BIA) and change in BP (pre-dialysis in-center readings, home self-monitored readings as well as 44-hour interdialytic BP).
Secondary outcomes include change in target post-dialysis weight, slope of on-line relative plasma volume monitoring (using Crit-line monitors), utilization and change, if any, in antihypertensive regimen, change in interdialytic weight gain, objectively assessed salt-appetite, thirst score, frequency of intradialytic hypotension, cramps and duration of post-dialysis fatigue and recovery, time to achievement of dry weight and laboratory parameters (hemoglobin, albumin, brain natriuretic peptide-BNP, aldosterone and hsCRP).
The trial will be 14-weeks in duration and will involve comprehensive assessment of study parameters at baseline, middle and end of the trial.
It is anticipated that the trial will lead to the the development of a simple and practical approach for volume and BP control in HD patients that will subsequently need to be studied on a larger scale, i.e., a larger, multicenter study with hard endpoints of death and hospitalization.
研究类型
介入性
注册 (实际的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Michigan
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Ann Arbor、Michigan、美国、48104
- University Dialysis Unit
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Livonia、Michigan、美国、48152
- University of Michigan Dialyisis Unit
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Stable adult HD patient (age 18-85 years)
- Usual in-center pre-dialysis systolic blood pressure of ≥130mmHg. For this purpose mean of pre-dialysis sitting blood pressures for the past one month prior to randomization will be applied for evaluation of inclusion criteria.
- Able and willing to adhere to study protocol
Exclusion Criteria:
- Recent acute illness (≤1month)
- Recent hospitalization (≤1month)
- Any psychological condition that could interfere with compliance with study protocol.
- Amputation of both lower limbs (due to interference with electric current for BIA measurement)
- Pacemaker, defibrillator, implantable pump, artificial joint, pins, plates or other types of metal objects in the body (other than dental fillings), if their presence interfere with appropriate measurements. In such patients consideration will be given to only doing the calf-BIA measurements and not the total body, at the discretion of the investigators.
- Use of any investigational product or device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.
- Pregnancy or lactation (pregnancy test will be applied only if the patient is in the reproductive age range).
- Any condition that, in the view of the PI, places the subject at high risk of poor treatment compliance or of not completing the study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Treatment
The existing target post-HD weight will be progressively challenged by removing additional fluid in small increments. |
1. Lower sodium intervention:
The existing target post-HD weight will be progressively challenged by removing additional fluid in small increments, unless clinical evidence of volume depletion or hypotension precludes this challenge in the intervention arm.
To avoid the occurrence of intradialytic hypotension, the ultrafiltration rate shall not exceed15 ml/kg/hour and post dialysis weight will not be reduced by more than 0.5 kg per dialysis session.
In some patients, this may warrant prolongation of the treatment time to achieve lowering of target post dialysis weight, and this process of target weight reduction may need to continue up to and through the interim assessment phase (6-8 weeks).
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无干预：Control
Usual care in addition to Blood pressure monitoring and and Hydration status monitoring
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Blood Pressure
大体时间：Pre-dialysis BP measure at Baseline, 6 Weeks and 12 weeks. ABPM measured at baseline and 12 Weeks. Home BP measure through out the 12week period on non-dialysis days
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Change in blood pressure (pre-dialysis in-center blood pressure readings, ABPM and home BP monitoring)
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Pre-dialysis BP measure at Baseline, 6 Weeks and 12 weeks. ABPM measured at baseline and 12 Weeks. Home BP measure through out the 12week period on non-dialysis days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Post-dialysis Weight
大体时间：12weeks
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Change in target post-dialysis weight
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12weeks
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Heart Rate
大体时间：12 weeks
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Change in heart rate
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12 weeks
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Plasma Volume
大体时间：12 Weeks
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Slope of relative plasma volume monitoring
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12 Weeks
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Medication Use
大体时间：12 Weeks
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Change in the utilization of antihypertensive medication ( number of medication and dose)
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12 Weeks
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Interdialytic Weight gain
大体时间：12 Weeks
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Change in the mid-week interdialytic weight gain
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12 Weeks
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Intradialytic Hypotension
大体时间：12 Weeks
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Frequency of intradialytic hypotension; defined as drop in systolic blood pressure associated with symptoms suggestive of low blood pressure such as lightheadedness, dizziness, sweating, etc., or decrease in intradialytic systolic blood pressure to less than 90 mmHg.
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12 Weeks
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Salt Appetite
大体时间：Baseline, 6 week and 12 week
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A measure of salt taste impairment and preference
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Baseline, 6 week and 12 week
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Thirst Score
大体时间：Baseline, 6 week, 12 weeks
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A measure of general thirst.
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Baseline, 6 week, 12 weeks
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Post-dialysis fatigue
大体时间：Baseline, 6 Weeks & 12 Weeks
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A measure of post-dialysis fatigue and recovery after each treatment session
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Baseline, 6 Weeks & 12 Weeks
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Routine Labs
大体时间：Baseline and 12Week
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o Routine labs including CBC, renal panel, hsCRP and brain natriuretic peptide (BNP).
Interdialytic urine collection for residual renal function (urea and creatinine clearance) estimation will be made.
Blood and urine samples will be archived for later analysis for biomarkers such as asymmetric dimethyl arginine (ADMA), plasma aldosterone, and urinary neutrophil gelatinase-associated lipocalin (NGAL), respectively
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Baseline and 12Week
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True Dry Weight
大体时间：12 weeks
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Time to achievement of true 'dry weight' (in the intervention arm only)
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12 weeks
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Hydration Status
大体时间：12 weeks
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Change in hydration status, as measured by BIA, using whole body and segmental techniques.
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12 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Rajiv Saran, MD、University of Michigan
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Bots CP, Brand HS, Veerman EC, Valentijn-Benz M, Van Amerongen BM, Valentijn RM, Vos PF, Bijlsma JA, Bezemer PD, Ter Wee PM, Amerongen AV. Interdialytic weight gain in patients on hemodialysis is associated with dry mouth and thirst. Kidney Int. 2004 Oct;66(4):1662-8. doi: 10.1111/j.1523-1755.2004.00933.x.
- Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ; Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Recommendations for blood pressure measurement in humans and experimental animals: Part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Hypertension. 2005 Jan;45(1):142-61. doi: 10.1161/01.HYP.0000150859.47929.8e. Epub 2004 Dec 20.
- Charra B. Fluid balance, dry weight, and blood pressure in dialysis. Hemodial Int. 2007 Jan;11(1):21-31. doi: 10.1111/j.1542-4758.2007.00148.x.
- Nanovic L. Electrolytes and fluid management in hemodialysis and peritoneal dialysis. Nutr Clin Pract. 2005 Apr;20(2):192-201. doi: 10.1177/0115426505020002192.
- Aybal Kutlugun A, Erdem Y, Okutucu S, Yorgun H, Atalar E, Arici M. Effects of lowering dialysate sodium on flow-mediated dilatation in patients with chronic kidney disease. Nephrol Dial Transplant. 2011 Nov;26(11):3678-82. doi: 10.1093/ndt/gfr092. Epub 2011 Mar 18.
- Munoz Mendoza J, Bayes LY, Sun S, Doss S, Schiller B. Effect of lowering dialysate sodium concentration on interdialytic weight gain and blood pressure in patients undergoing thrice-weekly in-center nocturnal hemodialysis: a quality improvement study. Am J Kidney Dis. 2011 Dec;58(6):956-63. doi: 10.1053/j.ajkd.2011.06.030. Epub 2011 Aug 27.
- Manlucu J, Gallo K, Heidenheim PA, Lindsay RM. Lowering postdialysis plasma sodium (conductivity) to increase sodium removal in volume-expanded hemodialysis patients: a pilot study using a biofeedback software system. Am J Kidney Dis. 2010 Jul;56(1):69-76. doi: 10.1053/j.ajkd.2009.12.037. Epub 2010 Mar 19.
- Ritz E, Dikow R, Morath C, Schwenger V. Salt--a potential 'uremic toxin'? Blood Purif. 2006;24(1):63-6. doi: 10.1159/000089439.
- Maruyama C. Improvement of Threshold-Dosage Salt Sensitivity Strips in Evaluating Reduced Salt Diets. The Japanese Journal of Nutrition and Dietetics 1988;46:211-6.
- Maruyama C. On Salt Taste Sensitivity of Healthy Patients and Patients with High Blood Pressure (Part 2). The Japanese Journal of Nutrition and Dietetics 1990;48:267-71.
- McCarley P. Patient empowerment and motivational interviewing: engaging patients to self-manage their own care. Nephrol Nurs J. 2009 Jul-Aug;36(4):409-13.
- Sinha AD, Light RP, Agarwal R. Relative plasma volume monitoring during hemodialysis AIDS the assessment of dry weight. Hypertension. 2010 Feb;55(2):305-11. doi: 10.1161/HYPERTENSIONAHA.109.143974. Epub 2009 Dec 28.
- Kurtz TW, Griffin KA, Bidani AK, Davisson RL, Hall JE; Subcommittee of Professional and Public Education of the American Heart Association. Recommendations for blood pressure measurement in humans and experimental animals. Part 2: Blood pressure measurement in experimental animals: a statement for professionals from the subcommittee of professional and public education of the American Heart Association council on high blood pressure research. Hypertension. 2005 Feb;45(2):299-310. doi: 10.1161/01.HYP.0000150857.39919.cb. Epub 2004 Dec 20.
- Urbina E, Alpert B, Flynn J, Hayman L, Harshfield GA, Jacobson M, Mahoney L, McCrindle B, Mietus-Snyder M, Steinberger J, Daniels S; American Heart Association Atherosclerosis, Hypertension, and Obesity in Youth Committee. Ambulatory blood pressure monitoring in children and adolescents: recommendations for standard assessment: a scientific statement from the American Heart Association Atherosclerosis, Hypertension, and Obesity in Youth Committee of the council on cardiovascular disease in the young and the council for high blood pressure research. Hypertension. 2008 Sep;52(3):433-51. doi: 10.1161/HYPERTENSIONAHA.108.190329. Epub 2008 Aug 4. No abstract available.
- Ware J, Snow K K, Kosnski M, Gandek B. SF-36 Health Survey: Manual and Interpretation Guide. Boston: Health Institute, 1993.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年9月1日
初级完成 (实际的)
2016年3月1日
研究完成 (实际的)
2016年3月1日
研究注册日期
首次提交
2013年1月9日
首先提交符合 QC 标准的
2013年1月10日
首次发布 (估计)
2013年1月11日
研究记录更新
最后更新发布 (估计)
2016年7月15日
上次提交的符合 QC 标准的更新
2016年7月14日
最后验证
2016年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Lower sodium intervention的临床试验
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动，不招人
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Massachusetts Institute of TechnologyHanger Clinic: Prosthetics & Orthotics招聘中