跳至主要内容
临床试验/NCT02763904
NCT02763904已完成不适用

Systematic Oral Nutritional Support in Hospitalized, Moderately Hypophagic Patients At Nutritional Risk Receiving Dietary Counseling: a Randomized, Controlled Trial

Emanuele Cereda2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2016年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
220
试验地点
2
主要终点
Body composition

研究概览

简要总结

Protein-calorie malnutrition is a frequent comorbidity in hospitalized patients and there is evidence that the nutritional status may influence the response to drug treatment, mortality, susceptibility to infections, the patient's functional status, duration of hospital stay and, consequently, overall healthcare costs. The causes of malnutrition are manifold. The underlying disease may in fact lead to an increase in the patient's energy needs, whether or not associated with a reduction in caloric intake. The same therapeutic treatments can further worsen the energy balance without considering that the patient can be kept fasting for the execution of some diagnostic procedures. Therefore, a further deterioration of nutritional status during hospitalization could occur.

International guidelines underline the utility to set a nutritional support whenever this is necessary, not only to prevent or treat malnutrition but also improve clinical outcomes. In this perspective, the improvement of oral diet and the use of oral nutritional supplements (ONS) represent the first-line strategy of intervention. Previous studies have shown that nutritional counseling, with or without the use of ONS, in patients with chronic disease is able to improve the calorie-protein intake, prevent deterioration of nutritional status, as well as to increase to a certain extent body weight. Particularly, energy-dense are more effective in increase energy intake. These data have highlighted the importance of a proper evaluation of the nutritional status of early detection of patients who could benefit of nutritional support. However, the independent role of the ONS in improving clinical outcome still needs to be established.

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
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Nutritional Risk Score [NRS-2002] ≥3
  • assessed within 48 hours since admission
  • expected length of stay ≥7 days
  • written informed consent

排除标准

  • age < 18 years
  • ongoing or indication to artificial nutrition
  • severe hypophagia (intake <50% of estimated requirements)
  • scheduled for surgery
  • indication to fasting
  • physician-based contra-indication to use of liquid oral nutritional supplements (vomitus, severe nausea, diarrhea, dysphagia)
  • physician-based indication to the of disease-specific oral nutritional supplements (e.g. kidney failure or pressure ulcers)
  • terminal illness
  • unavailability to planned measurements

结局指标

主要结局

Body composition

时间窗: 7 days

Change in phase angle as assessed by vectorial impedance analysis

次要结局

  • Body composition(Hospital stay, an average of 17 days)
  • Functional status(Hospital stay, an average of 17 days)
  • Energy intake(14 days)
  • Infections(Hospital stay, an average of 17 days)
  • Adverse events(Hospital stay, an average of 17 days)

研究者

发起方
Emanuele Cereda
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Emanuele Cereda

Fondazione IRCCS Policlinico San Matteo di Pavia

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (2)

Loading locations...

相似试验