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临床试验/NCT04758676
NCT04758676Unknown不适用

Bioelectric Impedance Analysis (BIA) Assessment of Polymyoneuropathy in Critically Ill Patients as a Part of Post-ICU Syndrome

University Hospital Ostrava4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
4
主要终点
Body composition

研究概览

简要总结

The aim of the study is to monitor and evaluate changes in body composition, with a special emphasis on muscle mass, in the context of polyneuromyopathy of critically-ill patients at ICU, on artificial ventilation (duration of artificial ventilation at least 7 days), and subsequent comparison with the patient's condition in 12 weeks, as a part of Post-Intensive Care Syndrome (PICS) monitoring. The effect of the package (nutritional recommendations + physiotherapy protocol vs. standard of care) will be evaluated.

详细描述

Intensive medicine keeps pushing its borders, and enables survival of critical illnesses, including the substitution of organ functions in patients with multiple organ dysfunction (MODS). Despite the improvements in short-term outcomes, the long-term prognosis and quality of life (long-term outcomes) in patients, who survived a critical condition at ICU, remain unfavorable. The long-term consequences may persist for months or even years.

Post-intensive care syndrome (PICS) represents a significantly limiting impairment in three areas: physical (polyneuromyopathy of critically-ill patients), cognitive (delirium), and mental (development of depressions and PTSD - post-traumatic stress disorder). It is especially the rapid deterioration of muscles caused with the catabolic effect of the illness itself during accentuated proteolysis, very negatively affects the muscle strength, inability to discontinue artificial ventilation in the patient, increase of infections, and prolongation of the ICU stay. It often results in the inability to discharge the patient into home care. Polyneuromyopathy affects up to 40% of critically-ill patients; at the greatest risk are especially patients in a serious catabolic state, with activated systemic inflammatory response, with microvascular ischemia, on corticosteroids, immobilized, and on long-term artificial ventilation. The prevention is difficult, as well as monitoring of the lean body mass (LBM), especially in the muscle mass of critically ill patients, who are further affected with changes in hydration and fluid leak.

BIA - bioelectric impedance is a non-invasive technique, which is able, on the basis of impedance, to evaluate body composition (muscles, fat, total body fluid), determine hydration (ratio of extracellular and intracellular fluid, fluid retention); another prognostic marker is also the phase angle. It helps to evaluate markers of nutrition, basal energetic metabolism.

The BIS Multiscan 5000 device measures 50 frequencies, which are used to create a Cole Plot, using a mathematical model. It enables obtaining data from bed-ridden critically-ill patients, using tetrapolar bioelectric impedance.

研究设计

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

盲法说明

No masking is used in the study

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

  • Patients with respiratory insufficiency
  • Expected period of artificial ventilation of 7 days
  • Acute lung injury (ALI)
  • Acute respiratory distress syndrome (ARDS)
  • Acute exacerbation of chronic obstructive pulmonary disease (COPD)
  • Signed informed consent (may be signed by witnesses, if the patient is unconscious)

排除标准

  • Patients with unfavorable prognosis for 12-week follow-up
  • APACHE Score >30
  • Metastasizing malignity
  • Patients after cardiopulmonary resuscitation (CPR) prior to admission
  • Cerebral edema
  • Cerebral trauma
  • Intracranial hypertension
  • Liver cirrhosis

结局指标

主要结局

Body composition

时间窗: 12 weeks

Body composition will be studied using bioimpedance analysis - comparison of skeletal muscle mass, fats, body fluids

次要结局

  • Changes in the C-reactive protein (CRP) level(12 weeks)
  • Changes in the albumin level(12 weeks)
  • Changes in the prealbumin level(12 weeks)
  • Comparison of muscle functions(12 weeks)
  • Changes in the presepsin level(12 weeks)

研究者

发起方
University Hospital Ostrava
申办方类型
Other
责任方
Sponsor

研究点 (4)

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