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임상시험 NCT07411014은(는) 쇼크, 중증 질환, 영양 지원, Vasopressor Therapy에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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Samsung Medical CenterEnteral Versus Parenteral Nutrition During Recovery After Shock 1,150
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임상시험 NCT07411014은(는) 쇼크, 중증 질환, 영양 지원, Vasopressor Therapy에 대해 알아보는 중재연구입니다. 현재 상태는 대상자모집전이며, 2026년 2월 1일부터 참여 신청이 가능합니다. 1,150명의 참여자를 모집할 예정입니다. Samsung Medical Center이(가) 진행하는 이 연구는 2029년 12월 31일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 2월 18일에 갱신되었습니다.
간단한 개요
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...
더 보기상세한 설명
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...
더 보기공식 제목
Enteral Versus Parenteral Nutrition During Early Recovery in the Critically Ill After Shock: A Prospective, Multicenter, Open-label, Randomized Controlled Study
질환명
쇼크중증 질환영양 지원Vasopressor Therapy출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- NOURISH
NCT 번호
실제 연구 시작일
2026-02-01
최신 업데이트 게시
2026-02-18
예상 연구 완료일
2029-12-31
계획된 등록 인원
1,150
연구종류
중재연구
단계/상
해당 없음
상태
대상자모집전
키워드
Enteral Nutrition
Parenteral Nutrition
Critically Ill Patients
Shock Recovery
Vasopressor Weaning
Shock
Parenteral Nutrition
Critically Ill Patients
Shock Recovery
Vasopressor Weaning
Shock
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Enteral 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. | 경장 영양 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. |
활성 대조군Parenteral 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. | 비경구 영양 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. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
19 Years
참여 가능한 성별
전체
- 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 Center연구 책임자
Jeong Hoon Yang, 책임연구자, Professor, Samsung Medical Center
연구 대표 연락처
연락처: Jeong Hoon Yang, 82-2-3410-3419, [email protected]
1 1개국에 임상시험 장소
Samsung Medical Center, Seoul, South Korea