Feeding method may determine survival in shock recovery
NCT ID NCT07411014
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether feeding through the gut (enteral nutrition) or through a vein (parenteral nutrition) leads to better outcomes for critically ill adults recovering from shock in the ICU. About 1,150 patients will be randomly assigned to one of the two feeding methods. The goal is to see which approach reduces deaths and infections during the ICU stay.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 1,150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
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A doctor treating you
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Contacts and locations
Locations
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Samsung Medical Center
Seoul, South Korea
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