NL-OMON42168尚未招募2 期
Protein intake, gastro-Intestinal tolerance and safety after administration of a new high protein tube feed in critically ill overweight ICU patients as compared to an isocaloric standard tube feed. - PROTI
utricia0 个研究点目标入组 22 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •1. Age * 18 years.
- •2. ICU stay and indication for tube feed via nasogastric tube.
- •3. Expected to require study product for at least 5 days on the ICU
- •4. BMI >= 25.0 kg/m2
排除标准
- •- Requiring other specific tube feed for medical reason.
- •- Having any contra-indication to receive tube feed such as severe shock, presence of partial or complete mechanical bowel obstruction, or intestinal ischemia or infarction.
- •- Abnormalities in GI tract which may impact GI function, such as short bowel syndrome - defined as entire length of small bowel totaling 122 centimeters or less-, Ulcerative Colitis or Crohn*s disease or any form of enterostomy.
- •- GI tract, abdominal or bariatric surgery within 72 hours before start intake study product or expected in the next 5 days after start study product intake.
- •- History of chronic pancreatitis or acute pancreatitis
- •- Expected to need parenteral feeding.
- •- Expected to need protein supplementation other than study product
- •- SOFA score >12 from admission to the ICU until 24 hours after admission or until randomisation in case of randomisation before 24 hours after admission
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