Enteral Versus Parenteral Nutrition During Recovery After Shock

NCT07411014 | Not Yet Recruiting DMC

• 1 other identifier: NOURISH
• Study Type: interventional
• Target: 1,150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shock; Critical Illness; Nutritional Support; Vasopressor Therapy

Keywords

Enteral Nutrition; Parenteral Nutrition; Critically Ill Patients; Shock Recovery; Vasopressor Weaning; Shock

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (28)

• 28-day mortality

  within 28 days of study enrollment

• In-hospital mortality

  upto 90 days

• ICU length of stay

  upto 90 days

• Hospital length of stay

  upto 90 days

• Time to wean from vasopressor support

  Time from enrollment to discontinuation of all vasopressors for more than 24 hours

Study Arms (2)

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.

Other: enteral nutrition

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.

Other: Parenteral Nutrition

Interventions

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.

Enteral Nutrition (EN) Group

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.

Parenteral Nutrition (PN) Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 30983584 BACKGROUND

MeSH Terms

Conditions

Shock; Critical Illness; Hyperphagia

Interventions

Enteral Nutrition; Parenteral Nutrition

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Central Study Contacts

Jeong Hoon Yang

CONTACT

82-2-3410-3419; jhysmc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label Trail
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Enteral Nutrition (EN) Group and Parenteral Nutrition (PN) Group

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 13, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

KR (1)