NCT07583342Enrolling By Invitation4 期
Open-label, Multicenter, Phase IV, Study Evaluating RELiZORB Use for the Treatment of Feeding Intolerance in Adults With Moderate to Severe Acute Pancreatitis
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 15
- 试验地点
- 5
研究概览
简要总结
The goal of this study is to learn if Relizorb, a fat-digesting enzyme, can improve tolerance of tube feeds in adult patients with moderate to severe pancreatitis. The main question it aims to answer is:
Does Relizorb allow more nutrition to be delivered to participants than they received without it?
Participants will be observed with standard, universal monitoring after adding Relizorb to their nutrition regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Male or female aged 18 + years of age
- •Admission to the Surgical Intensive Care Unit in the Northwell Health hospital system
- •Moderate to severe acute pancreatitis based on Atlanta criteria
- •Inability to tolerate ≥75% of goal EN (25 kcal/kg/d)
排除标准
- •Moribund patients expected to expire within 120 hours
- •Evidence of unresolved intestinal obstruction, ischemia, bleeding, perforation, fistulas or tract discontinuity, or other contraindication for enteral nutrition
- •Diagnosis or evidence of C. Difficile or other gastrointestinal infection that may manifest with diarrhea
- •Pre-existing constipation defined as laxative or stool softener use prior to admission to the hospital
- •Patients receiving cancer-related treatment in the last 3 months
- •History of cystic fibrosis
- •Any other reason that the treating or investigator team considers to be a contraindication to enteral nutrition
研究者
Laura Hansen
Director of Surgical ICU, Surgery, Acute Care in Lenox Hill Hospital
Northwell Health
研究点 (5)
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