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Similar study has been published.
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| Name | Class |
|---|---|
| Shanghai 6th People's Hospital | OTHER |
| Shanghai Tongji Hospital, Tongji University School of Medicine | OTHER |
| Shanghai 10th People's Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intensive EN | Experimental | Intensive enteral nutrition is to performed until discharge with max during of 7 days |
|
| routine EN | Active Comparator | Routine enteral nutrition is to performed until discharge with max during of 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intensive enteral nutrition | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of hospital-acquired infections | Hospital-acquired infections include ventilator-associated pneumonia, bloodstream infection, and urinary catheter-associated infection | 28 days after ICU admission |
| Measure | Description | Time Frame |
|---|---|---|
| mortality of 28 days | 28 days after ICU admission | |
| ICU stay | from ICU admission to timepoint of patient's discharge or death, up to 12 months | |
| free days of mechanical ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Duming Zhu, doctor | Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 180 Fenglin Road | Shanghai | 20032 | China |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Shanghai Jinshan Hospital |
| OTHER |
| Shanghai Minhang Central Hospital | OTHER |
| RenJi Hospital | OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Shanghai East Hospital | OTHER |
| Xuhui Central Hospital, Shanghai | OTHER |
| Shanghai Tong Ren Hospital | OTHER |
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| routine enteral nutrition | Other | Attendings decide when and how EN should be administered according to guidelines from academic organizations, such as ESPEN or ASPEN. |
|
| during whole ICU stay, up to 12 months |
| rate of reaching 80% of energy target during 72 hours | first 72 hours 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 |