Enteral Versus Parenteral Nutrition During Recovery After Shock

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Shock; Critical Illness; Nutritional Support; Vasopressor Therapy
• Intervention / Treatment: Other: enteral nutrition; Other: Parenteral Nutrition

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 1150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeong Hoon Yang; Phone Number: 82-2-3410-3419; Email: jhysmc@gmail.com

Study Locations

• South Korea
  • Seoul, South Korea
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: enteral nutrition; 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.
Active Comparator: 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.	Other: Parenteral Nutrition; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Gastrointestinal Complications	During ICU stay, measured at ICU discharge	upto 90 days
Time to reach nutritional target	Measured at ICU discharge	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
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
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
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
Cumulative calorie (kcal) deficit		From enrollment day 0 to day 7

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: January 25, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Shock; Enteral Nutrition; Parenteral Nutrition; Critically Ill Patients; Shock Recovery; Vasopressor Weaning
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Critical Illness; Shock; Hyperphagia; Therapeutics; Nutrition Therapy; Feeding Methods; Nutritional Support; Enteral Nutrition; Parenteral Nutrition
• Other Study ID Numbers: NOURISH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No