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Enteral Versus Parenteral Nutrition During Recovery After Shock

ConditionsShockCritical IllnessNutritional SupportVasopressor Therapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSamsung Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 meet all screening criteria.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • enteral nutrition

    Other intervention

    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 Nutrition

    Other intervention

    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.

Treatment groups

1,150 Participants
are divided into 2 treatment groups
Group A: Enteral Nutrition (EN) GroupExperimental treatment 1 intervention
Group B: Parenteral Nutrition (PN) GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

28-day mortality

Time frame
within 28 days of study enrollment
2

In-hospital mortality

Measured at hospital discharge

Time frame
upto 90 days
3

ICU length of stay

Measured at ICU discharge

Time frame
upto 90 days
4

Hospital length of stay

Measured at hospital discharge

Time frame
upto 90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Samsung Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: