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The patients with sepsis are in high risk of malnutrition, which could contribute to infection, difficulty in weaning from ventilators. The investigators speculate whether nutrition therapy with high nitrogen could attenuate the malnutrition status and improve the outcome in these sepsis patients. In this prospective Randomized Controlled Trial, the investigators aim to compare high nitrogen intake with conventional nitrogen supply which were recommended in guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Nitrogen | Experimental | In this arm, daily nitrogen supply is as much as 2.5-3.0 g per kilogram (lean mass weight) |
|
| conventional nitrogen | Active Comparator | In this arm, daily nitrogen supply is 1.2-1.5g per kilogram (lean mass weight) as recommended by ESPEN guideline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nitrogen supply | Other | Nitrogen supply could be administered through amino acid in parenteral nutrition, proteins in enteral nutrition. |
|
| Measure | Description | Time Frame |
|---|---|---|
| all cause mortality | 28 days | |
| all cause mortality | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| duration on ventilators | patients enrolled will be followed for the duration of mechanical ventilation, an expcected average of 4 weeks | |
| ICU stay | patients enrolled will be followed for length of ICU stay, an expected average of 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Critical Care Medicine: Zhongshan Hospital | Shanghai | Shanghai Municipality | 200032 | 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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| infection incidence rate | Details of infection includes pneumonia, catheter-related blood stream infection, urinary tract infect, et al. Diagnosis of infection accords to symptoms, lab tests, imaging measurements and bacterial cultures. | 28 days |
| Liver function and renal function | Liver function is assessed through serum bilirubin and liver enzyme, renal function is assessed through serum urea nitrogen and creatinine. | on 1st. day, 3rd. day, 7th. day, 14th. day, 21st. day, 28th. day after enrollment |
| diameter of midpoint of musculus rectus femoris | diameter of the muscle is measured with percutaneous ultrasound | on 28th. day or endpoint of the trial |
| serum concentration of albumin, pre albumin, retinaldehyde binding protein, transferrin | on 7th. day , 14th. day, 21st. day, 28th. day after enrollment |
| change of body composition | on 7th.day, 14th.day, 21st.dat, 28th.day after enrollment |