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临床试验/NCT02656654
NCT02656654已完成不适用

Pilot Study to Evaluate the Efficacy of and the Tolerance to a Body Bandage to Maintain Fluid Balance in Patients With Severe Sepsis or in Septic Shock in an ICU

Centre Hospitalier Universitaire Dijon2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2015年4月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
2
主要终点
Fluid balance

研究概览

简要总结

Early and adequate fluid resuscitation (< 6 hours) in patients with circulatory failure is essential but may exacerbate oedema, which may itself: 1) aggravate pulmonary lesions and prolong mechanical ventilation, 2) aggravate organ failure and 3) increase mortality notably in patients with acute renal failure. Improving fluid balance is considered crucial in the management of patients in septic shock, but the efficacy of the measures currently proposed (diuretics associated or not with albumin and/or dialysis) is controversial. The investigators hypothesize that a whole-body compression using a body bandage could reduce capillary leakage and thus lead to faster restoration of a normal transmural pressure gradient in postcapillary venules and improve venous return.

This is the first study to evaluate mechanical compression using a body bandage to reduce oedema in septic shock.

To do this, a whole-body compression will be set up within the 12 hours following admission. Water balance will be monitored daily throughout the duration of the compression and vital status of patients will be search at 7 days, 28 days and 90 days.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Written informed consent from a person of trust,
  • Patients aged 18 years or over,
  • Admitted to a Medical ICU for less than 24 hours,
  • For severe sepsis or septic shock and requiring fluid resuscitation because of hypotension and/or persistent signs of circulatory shock,
  • On mechanical ventilation with orotracheal intubation,

排除标准

  • Person not covered by national health insurance
  • Recent abdominal or pelvic surgery,
  • Contra-indication for a body bandage (PAD, Compartment Syndrome, acute rhabdomyolysis, wounds),
  • Pregnant women,
  • Patients with severe sepsis or septic shock for more than 24 hours,
  • Patients who are moribund or in whom death is probably imminent (within 24h),
  • Patients who have given instructions not to be resuscitated,
  • Patients under ward of court.

结局指标

主要结局

Fluid balance

时间窗: At 7 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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