Enteral Versus Parenteral Nutrition During Early Recovery in the Critically Ill After Shock: A Prospective, Multicenter, Open-label, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,150
- 试验地点
- 1
- 主要终点
- Composite of ICU mortality and ICU-acquired infection
研究概览
简要总结
This study compares enteral nutrition and parenteral nutrition in critically ill adult patients recovering from shock while receiving decreasing doses of vasopressors in the intensive care unit.
Eligible patients will be randomly assigned to receive either enteral or parenteral nutrition during the early recovery phase of shock.
The study aims to determine whether enteral nutrition improves clinical outcomes, including ICU mortality and ICU-acquired infections, compared with parenteral nutrition.
详细描述
Critically ill patients with shock are at high risk of nutritional deficits, yet the optimal route of nutrition during the recovery phase of shock remains uncertain.
Although enteral nutrition is generally preferred in critical care, it is often delayed in patients receiving vasopressors due to concerns about gastrointestinal intolerance and ischemia.
Recent evidence suggests that patients with decreasing vasopressor requirements may tolerate enteral nutrition safely.
This multicenter, randomized, open-label trial enrolls adult ICU patients recovering from shock with decreasing vasopressor support.
Participants are randomized to receive either enteral nutrition or parenteral nutrition during the early recovery phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open Label Trail
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Screening Criteria:
- •Subjects must be at least 19 years of age at the time of screening.
- •Subjects must be admitted to the intensive care unit (ICU).
- •Subjects must be receiving vasopressor therapy for shock.
- •Subjects must have a documented history of maximum vasopressor requirement with a vasopressor-inotropic score (VIS) of 12 or greater, calculated as follows:
- •VIS = dopamine dose (µg/kg/min) + dobutamine dose (µg/kg/min) + 10 × milrinone dose (µg/kg/min) + 100 × epinephrine dose (µg/kg/min) + 100 × norepinephrine dose (µg/kg/min) + 10,000 × vasopressin dose (U/kg/min)
- •Inclusion Criteria:
- •Subjects must meet all screening criteria.
- •Subjects must have central venous access suitable for the administration of parenteral nutrition (PN).
- •Subjects must demonstrate a decreasing vasopressor requirement, defined as a current VIS of 12 or less at the time of enrollment.
排除标准
- •Subjects with contraindications to enteral nutrition (EN) or parenteral nutrition (PN) at the time of enrollment will be excluded.
- •Subjects requiring specific nutritional management, including but not limited to long-term home enteral nutrition, long-term parenteral nutrition, or a diagnosis of refeeding syndrome, will be excluded.
- •Subjects who are pregnant or breastfeeding will be excluded.
- •Subjects with severe comorbid conditions associated with an estimated life expectancy of less than three months will be excluded.
- •Subjects with a documented do-not-resuscitate (DNR) order will be excluded.
- •Subjects with active gastrointestinal bleeding will be excluded.
- •Subjects who have undergone gastrointestinal surgery within one month prior to enrollment will be excluded.
- •Subjects currently participating in another randomized controlled trial comparing enteral nutrition and parenteral nutrition will be excluded.
研究组 & 干预措施
Enteral Nutrition (EN) Group
In the enteral nutrition group, enteral nutrition is initiated during the early recovery phase of shock in critically ill adult patients. Nutrition is provided while patients are receiving decreasing doses of vasopressors in the intensive care unit, according to standard institutional protocols.
干预措施: enteral nutrition (Other)
Parenteral Nutrition (PN) Group
In the parenteral nutrition group, parenteral nutrition is administered during the early recovery phase of shock in critically ill adult patients. Nutrition is provided while patients are receiving decreasing doses of vasopressors in the intensive care unit, according to standard institutional protocols.
干预措施: Parenteral Nutrition (Other)
结局指标
主要结局
Composite of ICU mortality and ICU-acquired infection
时间窗: upto 90 days
During ICU stay. ICU acquired infection: Composite of ventilator-associated pneumonia, bacteremia, catheter-associated infection, urinary tract infection, soft tissue infection, and other infections
次要结局
- Delivered/prescribed protein ratio(upto 90 days)
- Cumulative calorie (kcal) deficit(From enrollment day 0 to day 7)
- SOFA score(From enrollment day 0 to day 7)
- Hypoglycemia rate during ICU stay(upto 90 days)
- Change of maximum blood glucose(From enrollment day 0 to day 7)
- Number of patients with liver dysfunction during ICU stay(upto 90 days)
- Change of Albumin level during ICU stay(upto 90 days)
- Change of Pre-albumin during ICU stay(upto 90 days)
- Non-nutritional calorie (kcal) delivered during ICU stay(upto 90 days)
- Delivered/prescribed calorie ratio(upto 90 days)
- Prokinetic drug use during ICU stay(upto 90 days)
- 28-day mortality(within 28 days of study enrollment)
- In-hospital mortality(upto 90 days)
- ICU length of stay(upto 90 days)
- Hospital length of stay(upto 90 days)
- Time to wean from vasopressor support(Time from enrollment to discontinuation of all vasopressors for more than 24 hours)
- Rate of feeding Intolerance(upto 90 days)
- Gastrointestinal Complications(upto 90 days)
- Time to reach nutritional target(upto 90 days)
- Calorie (kcal) delivered during ICU stay(upto 90 days)
- Protein (g) delivered during ICU stay(upto 90 days)
- Nutritional calorie (kcal) delivered during ICU stay(upto 90 days)
- Clinical Frailty Score(upto 90 days)
- Body mass index(upto 90 days)
- 48-hour lactate clearance(From enrollment to 48 hours after enrollment)
- Number of patients requiring new renal replacement therapy during ICU stay(upto 90 days)
- Number of patients requiring new insulin therapy during ICU stay(upto 90 days)
- Change of insulin dose(From enrollment day 0 to day 7)
研究者
Jeong Hoon Yang
Professor
Samsung Medical Center