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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.
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.
The study evaluates a composite outcome of ICU mortality and ICU-acquired infections, along with other clinically relevant secondary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enteral Nutrition (EN) Group | Experimental | 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. |
|
| Parenteral Nutrition (PN) Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enteral nutrition | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day mortality | within 28 days of study enrollment | |
| In-hospital mortality | Measured at hospital discharge | upto 90 days |
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Screening Criteria:
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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeong Hoon Yang | Contact | 82-2-3410-3419 | jhysmc@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30983584 | Background | Bourcier S, Combes A. The NUTRIREA-2 study. Lancet. 2019 Apr 13;393(10180):1501-1502. doi: 10.1016/S0140-6736(18)33198-2. No abstract available. |
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| ID | Term |
|---|---|
| D012769 | Shock |
| D016638 | Critical Illness |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| D010288 | Parenteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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Enteral Nutrition (EN) Group and Parenteral Nutrition (PN) Group
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Open Label Trail
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|
| Parenteral Nutrition | Other | 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. |
|
| 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 |
| D012816 | Signs and Symptoms |