Critical Illness
Conditions
Keywords
mechanical ventilation, enteral nutrition, feeding intolerance
Brief summary
Patients with mechanical ventilation are in risk of malnutrition, which could lead to worse outcome. According to guidelines released from authority organizations, enteral nutrition (EN) should be prior approach for critically ill patients. However, initiation and delivery of EN during the early period of ICU admission are frequently hampered, which results in underfeeding. The investigators speculate whether an intensive enteral nutrition strategy could reinforce the delivery of EN thereby improving outcomes. In this multi-center, prospective, randomized parallel clinical trial, the investigators aim to assess the feasibility, safety and outcomes of intensive enteral nutrition in mechanical-ventilated patients.
Interventions
OTHERintensive enteral nutrition
After recruitment, patients should be assessed for EN initiation during first 24 hours after ICU admission. 80% of energy target should be reached within 72 hours.
OTHERroutine enteral nutrition
Attendings decide when and how EN should be administered according to guidelines from academic organizations, such as ESPEN or ASPEN.
Sponsors
Shanghai 6th People's Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai 10th People's Hospital
Shanghai Jinshan Hospital
Shanghai Minhang Central Hospital
RenJi Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai East Hospital
Xuhui Central Hospital, Shanghai
Shanghai Tong Ren Hospital
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* predicted time of mechanical ventilation more than 48 hours
Exclusion criteria
* no enteral nutrition pathway * refuse to informal consent * surgeon refuse the protocol * palliative care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of hospital-acquired infections | 28 days after ICU admission | Hospital-acquired infections include ventilator-associated pneumonia, bloodstream infection, and urinary catheter-associated infection |
Secondary
| Measure | Time frame |
|---|---|
| ICU stay | from ICU admission to timepoint of patient's discharge or death, up to 12 months |
| free days of mechanical ventilation | during whole ICU stay, up to 12 months |
| mortality of 28 days | 28 days after ICU admission |
| EN-associated adverse events | during whole ICU stay, up to 12 months |
| rate of parenteral nutrition delivery | during whole ICU stay, up to 12 months |
| rate of reaching 80% of energy target during 72 hours | first 72 hours after ICU admission |
Countries
China
Outcome results
None listed