A Pilot Study to Evaluate the Effect of a Specific Enteral Formulation Designed to Improve Gastrointestinal Tolerance in the Critically Ill Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Diarrhea-free days during Enteral Nutrition (EN) administration to the patients in the Intensive Care Unit (ICU)
研究概览
简要总结
Specifically designed enteral formulations may improve the gastrointestinal tolerance during early enteral nutrition in the critically ill patient.
This pilot trial will permit testing the design of the full-scale study providing valuable data on the expected effect of the formulation, the variability, thus helping to better estimate the required sample size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, 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
- 否
入选标准
- •Male or female older than 18 years of age
- •All ICU patients
- •Expected ICU stay superior or equal to 5 days
- •Anticipated to receive tube feeding for at least 3 days
- •Informed consent obtained from patient or close relative
排除标准
- •Contraindication to enteral nutrition or to the placement of an enteral feeding tube
- •On enteral nutrition with superior or equal to 75% of caloric goal administered
- •Restriction in full intestinal support including protein administration
- •Parenteral nutrition of any kind unless due to enteral nutrition intolerance
- •History of allergy or intolerance to the study product components (test or control product)
- •Currently under therapeutic limitations. Non functional GI tract
- •Unwilling or unable to comply with study treatments
- •Currently participating or having participated in another clinical, interventional trial during the last month
结局指标
主要结局
Diarrhea-free days during Enteral Nutrition (EN) administration to the patients in the Intensive Care Unit (ICU)
时间窗: from EN start until end of treatment or ICU discharge (whatever comes first)
Patients will receive treatment for 10 days maximum
Number of diarrhea events per day during EN administration to the patients in the Intensive Care Unit (ICU)
时间窗: from EN start until end of treatment or ICU discharge (whatever comes firts)
Patients will receive treatment for 10 days maximum
次要结局
- Presence/absence of other abdominal symptoms(up to 10 days)
- Incidence and severity of diarrhea(up to 10 days)
- Changes in intra-abdominal pressure(up to 10 days)
- Incidence of nausea, vomiting and regurgitation(up to 10 days)
- Gastric residual volumes (>500 ml)(up to 10 days)
- Incidence of secondary infections(up to 10 days)
- Visual analogue scale for abdominal discomfort(up to 10 days)
- Need to use any drug interfering with the passage of nutrition(up to 10 days)
- Health Economic burden of Diarrhea during EN administration at ICU(up to 10 days)
- For blood glucose control(up to 10 days)
- Time to reach the full caloric goal(up to 10 days)
- Accumulated daily caloric deficit during 72 hs after start of the study(up to 10 days)
- Need for parenteral nutrition supplementation during ICU stay(up to 10 days)
- Nutritional assessment(up to 10 days)
- ICU Length of Stay, days on mechanical ventilation during ICU stay (mech. ventilation-free days), hospital LOS (length of stay)(up to 28 days)
- Microbiota profiling(up to 10 days)
- Determination of diarrhea pathogenicity(up to 10 days)
- Safety evaluation (blood sampling)(up to 10 days)
- AEs (adverse events) / SAEs (serious adverse events)(up to 28 days)