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临床试验/NCT02348996
NCT02348996已完成不适用

Randomized Study Comparing Analysis With Bioeletric Impedance and Clinical Evaluation to Determine Dry Weight in Hemodialyis Patients

Ana Elizabeth Prado Lima Figueiredo0 个研究点目标入组 57 人开始时间: 2014年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
57
主要终点
Change in dry weight(DW) status at 10 weeks

研究概览

简要总结

Adequate control of extracellular volume is a major goal of renal replacement therapy in patients with chronic renal disease. Fluid overload is present in the early stages of chronic kidney disease and contributes significantly to hypertension, arteriosclerosis and high prevalence of left ventricular hypertrophy. These are associated with high rates of morbidity and mortality in this group of patients, rates on dialysis in Brazil is around17.9 % per year. Dry weight during hemodialysis remains a delicate gap between hypervolemia and hypovolemic. Many studies have shown that tight control of post - dialysis weight is related to better outcomes in short term and higher long-term survival. Many methods have been proposed for estimating the hydration status of hemodialysis patients in an objective manner, including ultrasonography of the inferior vena cava and echocardiography. However, these methods are very time-consuming and cumbersome to use in daily practice. In most dialysis centers, the dry weight is evaluated on subjective clinical criteria, with trial and error and time consuming. It was recently introduced in Brazil to monitor body composition by multifrequency bioimpedance, called Body Composition Monitor ( BCM ) manufactured by Fresenius Medical Care. The BCM is a piece of bioimpedance spectrometry using a three compartment model, able to quantify objectively and accurately the extracellular volume and hydration status of each patient by measuring body resistance to an electric current. The procedure is safe, simple and relatively inexpensive. The BCM uses multi-frequency currents (ranging from 5 to 1000 KHz ). The availability of this device evaluation of body composition which assesses the dry weight more efficiently and objectively determine a target to be achieved to prevent left ventricular hypertrophy, hypertension better manage and improve cardiovascular outcomes, motivates us to perform this study. So the goal is to compare the efficacy between bioelectrical impedance analysis and clinical evaluation for suitability of dry weight in hemodialysis patients. A prospective, randomized, crossover study, which will include all chronic renal failure patients on hemodialysis at St. Luke 's Hospital (PUC - RS), including patients with at least three months on HD and over 18 years of age. The expected primary outcome is to achieve greater accuracy in determining the state of hydration and dry weight of these patients.

详细描述

All patients in the study will undergo a period of prior randomization of a week, where data will be registered such as pre and post blood pressure, average weight gain (delta weight) between sessions and transdialysis complications.

In the first phase, BIA and clinical evaluation to assess blood volume pre-hemodialysis session state in a single assessment will evaluate all patients in the study. The clinical assessment method of dry weight determination includes: patient history in search of signs and symptoms of volume overload, analysis of pre treatment blood pressure, adventitious sounds in pulmonary auscultation among others.

Patients will be randomized in a systematic manner into two groups:

Group A - Clinic Assessment (AC): patients will have dry weight determine by clinical examination, as unit routine, for four weeks. Clinical criteria for dry weight adjustments are: edema, dyspnea, reported shortness of breath, post dialysis blood pressure greater than or equal 140/90 mmHg.

Group B - bioimpedance (BIA): BIA was used to estimate dry weight for four weeks, pre first HD session of the week.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • hemodialysis patient over 18 years old that accepted to participate

排除标准

  • Patients with metal orthopedic implants, cardiac pacemakers, patients with amputated limbs, due to the failure of evaluation of these patients by bioelectrical impedance analysis (BIA) and patients who do not accept participate in the study or decide to leave during the period of study research.

结局指标

主要结局

Change in dry weight(DW) status at 10 weeks

时间窗: DW assessment every dialysis session for 10 weeks

Volume status would match dry weight and euvolemia

次要结局

  • Decreasing adverse events transdialysis(every dialysis session for 10 weeks)

研究者

发起方
Ana Elizabeth Prado Lima Figueiredo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ana Elizabeth Prado Lima Figueiredo

Professor

Pontificia Universidade Católica do Rio Grande do Sul

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