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.

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.

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.