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क्लिनिकल ट्रायल NCT07411014 के लिए सदमा, गंभीर बीमारी, पोषण समर्थन, Vasopressor Therapy वर्तमान में अभी भर्ती शुरू नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
खोज पर वापस जाएँ
Samsung Medical CenterEnteral Versus Parenteral Nutrition During Recovery After Shock 1,150
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT07411014 एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो सदमा, गंभीर बीमारी, पोषण समर्थन, Vasopressor Therapy से जुड़ा हुआ है। परीक्षण वर्तमान में अभी भर्ती शुरू नहीं चल रहा है। इसमें 1,150 प्रतिभागियों को शामिल करने की योजना है और प्रतिभागियों का नामांकन 1 फ़रवरी 2026 से शुरू होगा। Samsung Medical Center इस परीक्षण का नेतृत्व कर रहे हैं और इसके 31 दिसंबर 2029 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 18 फ़रवरी 2026 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
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...
और दिखाएँविस्तृत विवरण
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...
और दिखाएँआधिकारिक शीर्षक
Enteral Versus Parenteral Nutrition During Early Recovery in the Critically Ill After Shock: A Prospective, Multicenter, Open-label, Randomized Controlled Study
स्वास्थ्य स्थितियां
सदमागंभीर बीमारीपोषण समर्थनVasopressor Therapyप्रकाशन
इस नैदानिक परीक्षण के बारे में प्रकाशित वैज्ञानिक लेख और शोध पत्र:अन्य अध्ययन आईडी
- NOURISH
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2026-02-01
अंतिम अद्यतन प्रकाशित
2026-02-18
अध्ययन की समाप्ति तिथि (अनुमानित)
2029-12-31
नामांकन (अनुमानित)
1,150
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
अभी भर्ती शुरू नहीं
प्रमुख शब्द
Enteral Nutrition
Parenteral Nutrition
Critically Ill Patients
Shock Recovery
Vasopressor Weaning
Shock
Parenteral Nutrition
Critically Ill Patients
Shock Recovery
Vasopressor Weaning
Shock
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
प्रयोगात्मकEnteral 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. | एंटरल पोषण 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. |
सक्रिय तुलना समूहParenteral 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. | पैरेंट्रल पोषण 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. |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
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 |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
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 |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
19 Years
अध्ययन के लिए पात्र लिंग
सभी
- 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 Centerअध्ययन उत्तरदायी पक्ष
Jeong Hoon Yang, मुख्य अन्वेषक, Professor, Samsung Medical Center
अध्ययन केंद्रीय संपर्क
संपर्क: Jeong Hoon Yang, 82-2-3410-3419, [email protected]
1 1 देशों में अध्ययन स्थान
Samsung Medical Center, Seoul, South Korea