Critical Illness, Nutritional Support, Shock, Vasopressor Therapy
Conditions
Keywords
Enteral Nutrition, Parenteral Nutrition, Critically Ill Patients, Shock Recovery, Vasopressor Weaning, Shock
Brief 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. 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.
Interventions
OTHERenteral 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.
OTHERParenteral 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 parenteral nutrition during the early recovery phase of shock while receiving decreasing vasopressor support in the intensive care unit.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label Trail
Intervention model description
Enteral Nutrition (EN) Group and Parenteral Nutrition (PN) Group
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of ICU mortality and ICU-acquired infection | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 28-day mortality | within 28 days of study enrollment | — |
| In-hospital mortality | upto 90 days | Measured at hospital discharge |
| ICU length of stay | upto 90 days | Measured at ICU discharge |
| Hospital length of stay | upto 90 days | Measured at hospital discharge |
| Time to wean from vasopressor support | Time from enrollment to discontinuation of all vasopressors for more than 24 hours | — |
| Rate of feeding Intolerance | upto 90 days | 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 |
| Gastrointestinal Complications | upto 90 days | During ICU stay, measured at ICU discharge |
| Time to reach nutritional target | upto 90 days | Measured at ICU discharge |
| Calorie (kcal) delivered during ICU stay | upto 90 days | Measured daily at ICU discharge |
| Protein (g) delivered during ICU stay | upto 90 days | Measured daily at ICU discharge |
| Nutritional calorie (kcal) delivered during ICU stay | upto 90 days | Measured daily during ICU stay |
| Non-nutritional calorie (kcal) delivered during ICU stay | upto 90 days | Measured daily during ICU stay |
| Delivered/prescribed calorie ratio | upto 90 days | Measured daily during ICU stay |
| Delivered/prescribed protein ratio | upto 90 days | Measured daily during ICU stay |
| Cumulative calorie (kcal) deficit | From enrollment day 0 to day 7 | — |
| Clinical Frailty Score | upto 90 days | 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. |
| Body mass index | upto 90 days | 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. |
| 48-hour lactate clearance | From enrollment to 48 hours after enrollment | — |
| Number of patients requiring new renal replacement therapy during ICU stay | upto 90 days | Number of patients who did not require renal replacement therapy before enrollment but required renal replacement therapy after enrollment. |
| Number of patients requiring new insulin therapy during ICU stay | upto 90 days | Number of patients who did not require insulin therapy before enrollment, but required insulin therapy after enrollment |
| Change of insulin dose | From enrollment day 0 to day 7 | — |
| Prokinetic drug use during ICU stay | upto 90 days | — |
| SOFA score | From enrollment day 0 to day 7 | Sequential Organ Failure Assessment, 0-24, higher score means worse outcome |
| Hypoglycemia rate during ICU stay | upto 90 days | — |
| Change of maximum blood glucose | From enrollment day 0 to day 7 | — |
| Number of patients with liver dysfunction during ICU stay | upto 90 days | Abnormal values of either alanine transaminase or aspartate transaminase |
| Change of Albumin level during ICU stay | upto 90 days | — |
| Change of Pre-albumin during ICU stay | upto 90 days | — |
Countries
South Korea
Contacts
CONTACTJeong Hoon Yang
Outcome results
None listed