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临床试验/NCT00834145
NCT00834145Unknown不适用

Effect of Normatec Pump for Relief of Leg Edema in Patients With Right Heart Failure: Short- Intermediate- and Long-Term Outcomes

Hillel Yaffe Medical Center2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Patient weight

研究概览

简要总结

Mobilization of fluid from the legs with the Normatec pump in patients with right heart failure, may empty the "reservoir" in the legs from excessive fluid, enabling fluid overload to collect there rather than in the liver or in other third spaces. Thus, we hypothesize that patients will lose weight, feel better, look better, be less prone to infections in their legs and to congestion of the liver.

详细描述

The protocol will be divided into 2 parts:

  1. The initial pumping phase will be an in-hospital study, short term study. Patients will be randomly assigned to conventional/conservative treatment or to pump therapy. Within 24 hours of admission patients assigned to pump therapy will be recruited for the study and will begin therapy according to the protocol outlined in the table below. These patients will not be given diuretics unless required to because of shortness of breath with suspected left heart failure. Individualized programs regarding pumping frequency and pump parameters will be set for each patient and will be adjusted during the first few days and maintained throughout the study unless there is a reason to modify them.

Data on both the conventional/conservative and the pump arms of the study will be collected at similar intervals. The duration of the in-hospital period will not be extended because of the study and is expected to be 3-7 days. 2. An intermediate-term study in which the patients from the phase 1 study will be ambulatory. During this phase of the study the effect of continuous maintenance and optimization will be monitored. Patients will come to the hospital for their pumping session at which time the protocol tests will be performed. Patients that were assigned to the conventional/conservative arm in phase 1 will be examined as per protocol at 1, 2 and 3 weeks after admission but BNP levels will be repeated only after the 3rd week. 3. At 3 and 6 months after admission, the "long term" phase of the study, a systematic investigation regarding repeat hospitalizations and their causes will be carried out by telephone interview and by a review of admission data from hospital records.

研究设计

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

入排标准

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

入选标准

  • Hospitalized patients
  • Right heart failure secondary to pulmonary hypertension (cor pulmonale)
  • Pronounced leg edema

排除标准

  • Patients in sepsis
  • Hemodynamically unstable
  • Renal failure (creatinine >2 mg%)
  • Deep vein thrombosis
  • Pregnancy
  • Psychiatric/noncompliant patients
  • Patients who will not sign the informed consent form

结局指标

主要结局

Patient weight

时间窗: 3 and 6 months

次要结局

  • Leg circumference, Pulmonary pressures, Cardiac function(3 and 6 months)

研究者

申办方类型
Other Gov

研究点 (2)

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