跳至主要内容
临床试验/NCT03170401
NCT03170401已完成3 期

Protein-enhanced Enteral Nutrition and Metabolomics in Critically Ill Trauma and Surgical Patients

University of Washington2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
500
试验地点
2
主要终点
Serum Concentrations of Transthyretin at 3 Weeks After Injury.

研究概览

简要总结

The aim of this study is too determine the effect of enteral protein supplementation on biochemical measures of inflammation and protein metabolism in critically ill surgical patients. The investigators will also collect data on important clinical outcomes, including infectious complications, duration of mechanical ventilation and other measures of recovery from critical illness.

Hypothesis: That early supplemental protein will increase serum concentrations of transthyretin at three weeks after the onset of illness or injury. Secondarily, the investigators will test whether supplementation, reduces infectious complications and increases ventilator-free days.

详细描述

Critically ill patients are frequently undernourished. The investigator's observations indicate that surgical and trauma patients who require artificial nutrition are likely to be markedly undernourished during the first week of critical illness, will often require intensive and costly support for organ failure, have prolonged stays in the intensive care unit and extended hospitalizations. Nitrogen deficits are typically greater and receive less attention than caloric deficits. In some respects, the focus on avoiding caloric deficits may have missed the mark. A broader consideration of nutrient needs, such as protein, is required. For instance, there are observational data supporting the notion that protein intake is at least as important as caloric intake in promoting recovery in critical illness. Only recently have national guidelines (ASPEN 2016) begun to specifically address protein requirements (1.5 - 2.0 g/kg/day). For a number of years, the approach to these critically ill patients has included weekly measurements of 24 hour urine nitrogen excretion in order to better understand the protein deficits that develop. Based upon physician preference, the investigators can then use enteral protein supplementation to match the urinary nitrogen excretion in order to achieve net "zero" nitrogen balance. With supplemental protein administration, physicians are able to reduce this deficit and in some cases, generate a positive nitrogen balance. However, there are no data to indicate that this approach (which is included as part of the 2016 ASPEN guidelines) improves clinical outcomes. The most obvious mechanism whereby supplemental protein may influence outcomes by providing more metabolic substrate for protein building. Feeding the gut likely creates a more anabolic environment and additional protein may facilitate anabolism. However, it is not known whether protein supplementation improves markers of anabolism and protein synthesis. In this study, the investigators will measure the anabolic effect of supplemental protein by following serum transthyretin concentrations as part of the standard clinical care.The investigators postulate that supplemental protein will attenuate the drop in comparison to no supplemental protein and will hasten the return to normal concentrations.

The proposed study will test whether early, and standardized protein supplementation: (1) Increases protein delivery during the first 2 weeks after injury, (2) increases serum transthyretin concentrations at 3 weeks after injury (3) increases ventilator-free days.

Study aims:

The aim of this study is to determine the effect of enteral protein supplementation on biochemical measures of protein metabolism in critically ill surgical patients. The investigators will also collect data on important clinical outcomes, including infectious complications, duration of mechanical ventilation and other measures of recovery from critical illness. However, this study will not enroll a sufficient number of subjects to adequately test for differences in these clinical end-points.

Hypothesis

That early supplemental protein will, increase serum concentrations of transthyretin at three weeks after injury. Secondarily, the investigators will test whether supplementation reduces infectious complications and increases ventilator-free days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

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

  • Critically ill adult trauma (blunt and penetrating) victims
  • Other critically ill surgical patients
  • enteral nutrition required during the first 96 hours after injury
  • expected to require nutritional support for at least 1 week

排除标准

  • Significant chronic organ failure,
  • severe malnutrition pre-existing prior to ICU admission
  • not expected to survive from their traumatic injuries.
  • intestinal discontinuity
  • short bowel syndrome
  • bowel obstruction
  • enterocutaneous fistula
  • intestinal ischemia
  • massive gastrointestinal hemorrhage
  • inability to obtain enteral access.

结局指标

主要结局

Serum Concentrations of Transthyretin at 3 Weeks After Injury.

时间窗: 3 weeks after admission for injury

Transthyretin is a circulating biomarker of nutritional status and protein synthesis.

次要结局

  • Ventilator-free Days.(Within 28 days following admission to hospital following injury.)
  • Ventilator Associated Pneumonia.(At any point during the hospitalization.)

研究者

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

Grant E. O'Keefe

Professor of Surgery

University of Washington

研究点 (2)

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