NCT03487744终止不适用
Comparison of the Incidence of Diarrhea Using High and Low Osmolality Enteral Tube Feeding in Critically Ill Surgical Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of diarrhea at 72 hours
研究概览
简要总结
The purpose and primary objective of this study is to determine if there is an association between enteral tube feed (TF) osmolality and diarrhea in critically ill patients. The investigators hypothesize that the administration of a TF formulation with high osmolality will cause more diarrhea than a TF formulation with a lower osmolality.
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
- None
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
- •age >18 years
- •admitted to SICU or CVICU requiring TF for enteral nutrition
- •anticipated ICU stay and TF requirement >72 hours
排除标准
- •Contraindication to receiving one of the study TF formulations
- •Inability to tolerate at least 75% of estimated requirement by day 3 of enteral TF administration
- •Clostridium difficile infection or other cause of infectious diarrhea prior to study enrollment
- •Presence of an ileostomy or colostomy
- •History of inflammatory bowel disease, bowel resection, short gut syndrome, or chronic diarrhea
研究组 & 干预措施
Promote without fiber
Active Comparator
Lower osmolality enteral tube feed formulation
干预措施: Promote without fiber (Other)
Osmolite 1.5
Active Comparator
Higher osmolality enteral tube feed formulation
干预措施: Osmolite 1.5 (Other)
结局指标
主要结局
Incidence of diarrhea at 72 hours
时间窗: 72 hour
次要结局
- Total number of diarrhea days(14 days)
- Incidence of diarrhea at 14 days(14 days)
- Time at 75% or more of goal tube feeding rate(14 days)
- Incidence of perineal dermatitis(14 days)
- Mean frequency of diarrhea days(14 days)
- Incidence of hypokalemia(14 days)
- Mean diarrhea scores(14 days)
- Number of Clostridium difficile assays sent(14 days)
研究者
Amanda Zomp
Clinical Pharmacist
University of Utah
研究点 (1)
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