ShockNCT07411014
Enteral Versus Parenteral Nutrition During Recovery After Shock
A study testing enteral nutrition and Parenteral Nutrition in people with Shock and Critical Illness, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Shock, Critical Illness, Nutritional Support
- What is being tested?
- enteral nutrition and Parenteral Nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Shock, Critical Illness, Nutritional Support, Vasopressor Therapy
- Being tested
- enteral nutrition, Parenteral Nutrition
- Keywords
- Enteral Nutrition, Parenteral Nutrition, Critically Ill Patients, Shock Recovery, Vasopressor Weaning, Shock
- Medical subject headings
- Shock, Critical Illness, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Enteral Nutrition (EN) Group | Experimental | 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. Receives: Other: enteral nutrition |
| Parenteral Nutrition (PN) Group | Active comparator | 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. Receives: Other: Parenteral Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: upto 90 days
Secondary outcomes (28)
28-day mortality
Measured: within 28 days of study enrollment
In-hospital mortality
Measured at hospital discharge
Measured: upto 90 days
ICU length of stay
Measured at ICU discharge
Measured: upto 90 days
Hospital length of stay
Measured at hospital discharge
Measured: upto 90 days
Time to wean from vasopressor support
Measured: 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
Measured: upto 90 days
Gastrointestinal Complications
During ICU stay, measured at ICU discharge
Measured: upto 90 days
Time to reach nutritional target
Measured at ICU discharge
Measured: upto 90 days
Calorie (kcal) delivered during ICU stay
Measured daily at ICU discharge
Measured: upto 90 days
Protein (g) delivered during ICU stay
Measured daily at ICU discharge
Measured: upto 90 days
Nutritional calorie (kcal) delivered during ICU stay
Measured daily during ICU stay
Measured: upto 90 days
Non-nutritional calorie (kcal) delivered during ICU stay
Measured daily during ICU stay
Measured: upto 90 days
Delivered/prescribed calorie ratio
Measured daily during ICU stay
Measured: upto 90 days
Delivered/prescribed protein ratio
Measured daily during ICU stay
Measured: upto 90 days
Cumulative calorie (kcal) deficit
Measured: 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.
Measured: 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.
Measured: upto 90 days
48-hour lactate clearance
Measured: 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.
Measured: 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
Measured: upto 90 days
Change of insulin dose
Measured: From enrollment day 0 to day 7
Prokinetic drug use during ICU stay
Measured: upto 90 days
SOFA score
Sequential Organ Failure Assessment, 0-24, higher score means worse outcome
Measured: From enrollment day 0 to day 7
Hypoglycemia rate during ICU stay
Measured: upto 90 days
Change of maximum blood glucose
Measured: 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
Measured: upto 90 days
Change of Albumin level during ICU stay
Measured: upto 90 days
Change of Pre-albumin during ICU stay
Measured: upto 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Aug 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enteral Nutrition (EN) Group and Parenteral Nutrition (PN) Group
- Masking
- None (open label)
- Enrolment
- 1,150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Hoon Yang, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411014
- Sponsor's protocol ID
- NOURISH
- Status last verified
- Feb 2026
- First submitted
- 25 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 30983584
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteral Versus Parenteral Nutrition During Early Recovery in the Critically Ill After Shock: A Prospective, Multicenter, Open-label, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07411014
- Acronym / sponsor ID
- NOURISH
- Conditions
- Shock, Critical Illness, Nutritional Support, Vasopressor Therapy
- Keywords
- Enteral Nutrition, Parenteral Nutrition, Critically Ill Patients, Shock Recovery, Vasopressor Weaning, Shock
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,150 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Enteral Nutrition (EN) Group and Parenteral Nutrition (PN) Group
| Arm | Type | Receives |
|---|---|---|
| Enteral Nutrition (EN) Group | Experimental | Other: enteral nutritionIn 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. |
| Parenteral Nutrition (PN) Group | Active comparator | Other: Parenteral NutritionIn 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enteral nutritionPatients 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 | Enteral Nutrition (EN) Group |
| Parenteral NutritionPatients 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. | Other | Parenteral Nutrition (PN) Group |
Primary outcome
Composite of ICU mortality and ICU-acquired infection
Time frame: upto 90 days
During ICU stay. ICU acquired infection: Composite of ventilator-associated pneumonia, bacteremia, catheter-associated infection, urinary tract infection, soft tissue infection, and other infections
28 secondary outcomes
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
Delivered/prescribed calorie ratio
Time frame: upto 90 days
Delivered/prescribed protein ratio
Time frame: upto 90 days
Cumulative calorie (kcal) deficit
Time frame: From enrollment day 0 to day 7
Clinical Frailty Score
Time frame: upto 90 days
Body mass index
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
Time frame: upto 90 days
Number of patients requiring new insulin therapy during ICU stay
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Background: PubMed 30983584Bourcier 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enteral nutrition and Parenteral Nutrition in people with Shock and Critical Illness, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeong Hoon Yang (82-2-3410-3419, jhysmc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of ICU mortality and ICU-acquired infection (time frame: upto 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07411014, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.