NCT05112328招募中不适用
The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding: Prospective Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Change of Phase angle (°)
研究概览
简要总结
Determine the effect of high-dose pancreatic enzyme supplementation on nutritional indicators and clinical course in critically ill patients undergoing enteral nutrition.
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
- •Adults 19 years and older
- •Hospitalized in the surgical/medical intensive care unit of the Seoul National University Hospital
- •Enteral nutrition
- •Patients who consented to this study
- •Patients with risk factors for pancreatic exocrine dysfunction
- •Shock (Norepinephrine)
- •Sepsis (3 rd definition of sepsis)
- •Cardiac arrest
- •hyperlactatemia serum lactate > 2 mmol/L)
- •Mechanical ventilation
- •Continuous renal replacement therapy
排除标准
- •chronic pancreatitis
- •unresectable pancreatic cancer
- •History of pancreatectomy
- •Underlying diseases in which the effect of Exocrine pancreatic enzyme administration is difficult to show
- •Inflammatory bowel disease
- •Short bowel syndrome
研究组 & 干预措施
Intervention
Experimental
Exocrine Pacancreatic enzyme(Norzyme Capsule 40000 capsules) after meals 3 times a day
干预措施: Exocrine Pancreatic Enzyme (Drug)
Control
Placebo Comparator
Placebo after meals 3 times a day
干预措施: Placebo (Drug)
结局指标
主要结局
Change of Phase angle (°)
时间窗: Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition
Change from Baseline Phase angle (°) at 2 weeks or discharge
次要结局
- Skeletal Muscle Mass (SMM) (kg)(Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition)
研究者
Seung-Young Oh
Clinical Assistant Professor
Seoul National University Hospital
研究点 (1)
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