试验雷达 AI
临床试验 NCT07411014 针对休克，重症疾病，营养支持，Vasopressor Therapy目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。
一个试验符合筛选条件
卡片视图
返回搜索

Enteral Versus Parenteral Nutrition During Recovery After Shock 1,150

尚未招募
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT07411014是一项针对休克，重症疾病，营养支持，Vasopressor Therapy的干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年2月1日开始，预计招募1,150名患者。该研究由Samsung Medical Center主导，计划于2029年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年2月18日。
简要概括
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, inclu...

显示更多
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 vasopress...

显示更多
官方标题

Enteral Versus Parenteral Nutrition During Early Recovery in the Critically Ill After Shock: A Prospective, Multicenter, Open-label, Randomized Controlled Study

疾病
休克重症疾病营养支持Vasopressor Therapy
出版物
关于此临床试验发表的科学文章和研究论文：
其他研究标识符
  • NOURISH
NCT编号
NCT07411014
实际开始日期
2026-02-01
最近更新发布
2026-02-18
预计完成日期
2029-12-31
计划入组人数
1,150
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
关键词
Enteral Nutrition
Parenteral Nutrition
Critically Ill Patients
Shock Recovery
Vasopressor Weaning
Shock
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
参与者组/试验组干预措施/治疗方法
实验性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.
肠内营养
Patients will be randomized in a 1:1 ratio to receive either enteral nutrition or parenteral nutrition. Participants assigned to this group will receive enteral nutrition during the early recovery phase of shock while receiving decreasing vasopressor support in the intensive care unit.
阳性对照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.
肠外营养
Patients will be randomized in a 1:1 ratio to receive either enteral nutrition or parenteral nutrition. Participants assigned to this group will receive parenteral nutrition during the early recovery phase of shock while receiving decreasing vasopressor support in the intensive care unit.
主要终点
结果指标度量标准描述时间框架
Composite of ICU mortality and ICU-acquired infection
During ICU stay. ICU acquired infection: Composite of ventilator-associated pneumonia, bacteremia, catheter-associated infection, urinary tract infection, soft tissue infection, and other infections
upto 90 days
次要终点
结果指标度量标准描述时间框架
28-day mortality
within 28 days of study enrollment
In-hospital mortality
Measured at hospital discharge
upto 90 days
ICU length of stay
Measured at ICU discharge
upto 90 days
Hospital length of stay
Measured at hospital discharge
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
Defined as presence of one or more of following during ICU stay, measured at ICU discharge: High Gastric Residual Volume Gastric residual volume of more than 250 cc Vomiting The occurrence of any visible regurgitation of gastric content irrespective of the amount more than 2 times per day Diarrhea 3 or more loose/liquid stools per day with stool weight greater than 250g/day Abdominal Distension Clinically or radiologically confirmed distension of abdomen
upto 90 days
Gastrointestinal Complications
During ICU stay, measured at ICU discharge
upto 90 days
Time to reach nutritional target
Measured at ICU discharge
upto 90 days
Calorie (kcal) delivered during ICU stay
Measured daily at ICU discharge
upto 90 days
Protein (g) delivered during ICU stay
Measured daily at ICU discharge
upto 90 days
Nutritional calorie (kcal) delivered during ICU stay
Measured daily during ICU stay
upto 90 days
Non-nutritional calorie (kcal) delivered during ICU stay
Measured daily during ICU stay
upto 90 days
Delivered/prescribed calorie ratio
Measured daily during ICU stay
upto 90 days
Delivered/prescribed protein ratio
Measured daily during ICU stay
upto 90 days
Cumulative calorie (kcal) deficit
From enrollment day 0 to day 7
Clinical Frailty Score
Score 1\~9, 1 indicating better and 9 indicating worse outcome. Measured at enrollment, at ICU dischage, and at hospital discharge. When ICU discharge or hospital discharge was not met before day 90, then clinical frailty scale is measured at day 90, instead.
upto 90 days
Body mass index
Measured at enrollment, at ICU dischage, and at hospital discharge. When ICU discharge or hospital discharge was not met before day 90, then body mass index is measured at day 90, instead.
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
Number of patients who did not require renal replacement therapy before enrollment but required renal replacement therapy after enrollment.
upto 90 days
Number of patients requiring new insulin therapy during ICU stay
Number of patients who did not require insulin therapy before enrollment, but required insulin therapy after enrollment
upto 90 days
Change of insulin dose
From enrollment day 0 to day 7
Prokinetic drug use during ICU stay
upto 90 days
SOFA score
Sequential Organ Failure Assessment, 0-24, higher score means worse outcome
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
Abnormal values of either alanine transaminase or aspartate transaminase
upto 90 days
Change of Albumin level during ICU stay
upto 90 days
Change of Pre-albumin during ICU stay
upto 90 days
参与助手
资格标准

适龄参与研究
成人, 老年人
最低年龄要求
19 Years
适龄性别
全部
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)

  • 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.

  • 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.
Samsung Medical Center logoSamsung Medical Center
研究责任方
Jeong Hoon Yang, 主要研究者, Professor, Samsung Medical Center
研究中心联系人
联系人: Jeong Hoon Yang, 82-2-3410-3419, [email protected]
1 位于 1 个国家/地区的研究中心
Samsung Medical Center, Seoul, South Korea