Enteral Versus Parenteral Nutrition During Recovery After Shock

Official title

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

Overview

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.

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Composite of ICU mortality and ICU-acquired infection [Time frame: upto 90 days]

Secondary outcome measures (12)

• 28-day mortality [Time frame: within 28 days of study enrollment]
• In-hospital mortality [Time frame: upto 90 days]
• ICU length of stay [Time frame: upto 90 days]
• Hospital length of stay [Time frame: upto 90 days]
• Time to wean from vasopressor support [Time frame: Time from enrollment to discontinuation of all vasopressors for more than 24 hours]
• Rate of feeding Intolerance [Time frame: upto 90 days]
• Gastrointestinal Complications [Time frame: upto 90 days]
• Time to reach nutritional target [Time frame: upto 90 days]
• Calorie (kcal) delivered during ICU stay [Time frame: upto 90 days]
• Protein (g) delivered during ICU stay [Time frame: upto 90 days]
• Nutritional calorie (kcal) delivered during ICU stay [Time frame: upto 90 days]
• Non-nutritional calorie (kcal) delivered during ICU stay [Time frame: upto 90 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

South Korea · 1 center

• Samsung Medical Center — Seoul

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. PMID 30983584

Identifiers

NCT: NCT07411014 · NOURISH

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗