An interventional study of enteral nutrition and Parenteral Nutrition in Shock, Critical Illness and Nutritional Support, sponsored by Samsung Medical Center. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment
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:
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:
Exclusion Criteria:
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
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 enteral nutrition during the early recovery phase of shock while receiving decreasing vasopressor support in the intensive care unit.
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.
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
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
Plan to share: Undecided
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Samsung Medical Center