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临床试验/NCT01907347
NCT01907347已完成不适用

PHASE ANGLE PROJECT

University Hospital, Geneva10 个研究点 分布在 9 个国家目标入组 1,000 人开始时间: 2013年3月1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
1,000
试验地点
10
主要终点
Mortality

研究概览

简要总结

Critically ill patients feature a loss of fat-free mass (FFM) up to 440 g/day, which is associated with increased morbidity and prolonged recovery. In several clinical conditions, FFM or phase angle (PhA)derived from BIA have been associated with clinical outcome. However, solid data to support this association in ICU patients are lacking. Only one retrospective study of 51 ICU patients with acute respiratory failure correlated loss of active cell mass with mortality. In a pilot study performed in 55 ICU patients, the investigators observed that five kHz BIA PhA was significantly related to SOFA (r=0.38, P=0.03). The relation between PhA and mortality remains to be determined in ICU patients.

Classic ICU validated severity scores (e.g. Acute Physiology and Chronic Health Evaluation (APACHE), Sequential Organ Failure Assessment (SOFA), Simplified Acute Physiology Score (SAPS)) and recent nutritional scores have been developed to foresee the clinical outcome of ICU patients. Most of these scores are time consuming and suffer some degree of discriminative power (i.e. APACHE II and SAPS II are not validated in cardiovascular surgery patients).

PhA is reflecting intracellular status: altered intracellular water (ICW) to extracellular water (ECW) distribution is suggested by low PhA. PhA measurement does not require anamnestic parameters, body weight, and lab tests. It could easily, accurately and repeatedly measured at bedside. PhA has been correlated with the disease prognosis in HIV infection, hemodialysis, peritoneal dialysis, chronic renal failure and liver cirrhosis patients. These studies suggest that PhA may be useful in determining increased risk of morbidity in the ICU.

Computerized tomography (CT) images targeted on the 3rd lumbar vertebrae (L3) could accurately measure FFM13 and predict survival in cancer patients. Body composition evaluation by CT presents great practical significance due to its routine ICU use in the initial diagnosis or follow-up. The usefulness of measuring FFM with L3-targeted CT has never been evaluated in ICU patients.

Therefore, the investigators aim to conduct an international multicentre prospective observational study in ICU patients to assess the prognosis value of BIA PhA at admission, and to compare the performances of BIA and L3-targeted CT for FFM measurement.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • equal or more than 18 years
  • expected ICU length of stay of more than 48 hours
  • no readmission within the 48 hours following ICU discharge
  • no Implanted Cardiac Devices
  • no pregnancy or lactation
  • affiliated to health insurance regimen
  • informed consent by patient or next of kin.

排除标准

  • age below 18 years
  • expected ICU length of stay <48 hours
  • readmission within the 48 hours following ICU discharge
  • Implanted Cardiac Devices
  • pregnancy or lactation
  • non affiliated to health insurance regimen
  • no informed consent by patient or next of kin.

结局指标

主要结局

Mortality

时间窗: 28-day after intensive care unit admission

To determine the impact of phase angle at ICU admission, and phase angle changes during ICU stay, on 28-day mortality

次要结局

  • length of mechanical ventilation(day 1 to day 28 after ICU admission)
  • ICU length of stay(day 1 to ICU discharge or death)
  • ICU severity scores, APACHE II and SAPS II(within the 48 first hours of ICU stay)
  • number of nosocomial infections(28 day after the intensive care unit admission)
  • hospital length of stay(day 1 to hospital discharge)
  • fat-free mass measurement by bioimpedance analysis and third lumbar vertebra-targeted computerized tomography(day 1 to day 28)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Claude Pichard

Professor, MD, PhD, Head, Clinical Nutrition

University Hospital, Geneva

研究点 (10)

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