Enteral Versus Parenteral Nutrition During Recovery After Shock

N/ANot Yet RecruitingNCT07411014

Samsung Medical Center1,150 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,150

Conditions

Shock

Interventions

enteral nutritionOTHER

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.

Parenteral NutritionOTHER

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: upto 90 days

Secondary Outcomes

28-day mortality

Time frame: within 28 days of study enrollment

In-hospital mortality

Measured at hospital discharge

Time frame: upto 90 days

ICU length of stay

Measured at ICU discharge

Time frame: upto 90 days

Hospital length of stay

Measured at hospital discharge

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

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

Time frame: upto 90 days

Gastrointestinal Complications

During ICU stay, measured at ICU discharge

Time frame: upto 90 days

Time to reach nutritional target

Measured at ICU discharge

Time frame: upto 90 days

Calorie (kcal) delivered during ICU stay

Measured daily at ICU discharge

Time frame: upto 90 days

Protein (g) delivered during ICU stay

Measured daily at ICU discharge

Time frame: upto 90 days

Nutritional calorie (kcal) delivered during ICU stay

Measured daily during ICU stay

Time frame: upto 90 days

Non-nutritional calorie (kcal) delivered during ICU stay

Measured daily during ICU stay

Time frame: upto 90 days

Delivered/prescribed calorie ratio

Measured daily during ICU stay

Time frame: upto 90 days

Delivered/prescribed protein ratio

Measured daily during ICU stay

Time frame: upto 90 days

Cumulative calorie (kcal) deficit

Time frame: 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.

Time frame: 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.

Time frame: upto 90 days

48-hour lactate clearance

Time frame: 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.

Time frame: 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

Time frame: upto 90 days

Change of insulin dose

Time frame: From enrollment day 0 to day 7

Prokinetic drug use during ICU stay

Time frame: upto 90 days

SOFA score

Sequential Organ Failure Assessment, 0-24, higher score means worse outcome

Time frame: From enrollment day 0 to day 7

Hypoglycemia rate during ICU stay

Time frame: upto 90 days

Change of maximum blood glucose

Time frame: 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

Time frame: upto 90 days

Change of Albumin level during ICU stay

Time frame: upto 90 days

Change of Pre-albumin during ICU stay

Time frame: upto 90 days

Enteral Versus Parenteral Nutrition During Recovery After Shock

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts