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临床试验/NCT02632630
NCT02632630已完成2 期

Nutrition Supplementation in Hospitalized Patients: A Randomized Controlled Trial

Lawson Health Research Institute1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
100
试验地点
1
主要终点
Successful participant recruitment

研究概览

简要总结

Patients with severe malnutrition risk are 7.4 times more likely to die in hospital than well-nourished patients, and carry a 30-day readmission rate of >46%. Although malnutrition is common and is associated with extremely poor outcomes, it is neglected and undertreated. This is a randomized controlled pilot trial to rapidly identify at-risk hospitalized medical patients, and then provide nutritional supplementation in hospital and after discharge for 28 days. In select at-risk patients, 5 days of nutrition delivered through a peripheral vein will be used in addition to oral nutritional supplementation.

详细描述

In this pilot trial, the feasibility of the trial protocol will be established in two centres in Canada. Patients at high risk of malnutrition will be identified within 48 hours of hospital admission using Subjective Global Assessment criteria. Patients will be randomized in a factorial design fashion via a centralized, internet-based randomization protocol to one of the following arms:

  1. Peripheral parenteral nutrition and enhanced oral supplementation;
  2. Peripheral parenteral nutrition and standard care for oral supplementation;
  3. Standard care for parenteral fluid administration and enhanced oral supplementation;
  4. Standard care for parenteral fluid administration and standard of care for oral supplementation.

Peripheral parenteral nutrition (PPN) is intravenous nutrition consisting of dextrose, amino acids, fat, and electrolytes through a peripheral vein. Peri-OLIMEL 2.5% E, parenteral solution (Baxter) will be administered in this study. Patients will be randomized to PPN vs. standard care intravenous maintenance fluid administration for up to 5 days of hospitalization or until discharge, whichever is sooner. The PPN will be administered in place of their maintenance crystalloid solution, and will be adjusted or stopped as clinically indicated by the attending medical team.

If there is no maintenance crystalloid fluid administration, the parenteral nutrition solution will be administered at a rate of 0.85mL/kg/hour.

The minimum infusion rate will be 45 mL per hour (for participants who weigh 53 kg or less). The minimum infusion rate would provide a supplementation of 1,080 kcal/day.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Subjective Global Assessment (SGA) category B or C.
  • Have been hospitalized for less than 48 hours.

排除标准

  • Have an allergy or intolerance to any component of the oral supplement or parenteral nutrition.
  • Have a contraindication to administration of IV fluid (i.e. are in volume overloaded state, are being given IV furosemide).
  • Are currently suffering from refeeding syndrome.
  • Have a pre-existing medical condition that prevents oral intake of full fluids.
  • Have a diagnosis or suspicion of septic shock.
  • Have an expected length of stay of less than 48 hours from the time of assessment.
  • Have a current diagnosis of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome.

研究组 & 干预措施

Amino Acids w/Electrolytes in Dextrose

Active Comparator

Peripheral parenteral nutrition (PPN)

干预措施: Amino Acids w/Electrolytes in Dextrose (Drug)

Ensure product

Active Comparator

Calorie and protein dense oral nutritional supplement for patients with elevated nutritional needs.

干预措施: Ensure product (Dietary Supplement)

Crystalloid solutions

Active Comparator

Standard care intravenous maintenance fluids.

干预措施: Crystalloid solutions (Drug)

Oral nutritional supplementation

Active Comparator

Nutrient-enhanced drink products that provide macronutrients and micronutrients with the aim of increasing oral nutritional intake.

干预措施: Oral nutritional supplementation (Dietary Supplement)

结局指标

主要结局

Successful participant recruitment

时间窗: 12 months

This pilot study will demonstrate feasibility of recruitment if investigators are able to recruit 100 participants over 12 months. A total recruitment of 15 patients/month is considered as reasonable given the high numbers of competing studies, missed patients, and consent failure rates.

次要结局

  • Adherence to treatment(30 days)
  • Number of participants to experience clinical re-feeding syndrome.(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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