Critically Ill
Conditions
Keywords
mechanical ventilation
Brief summary
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.
Interventions
OTHERnitrogen supply
Nitrogen supply could be administered through amino acid in parenteral nutrition, proteins in enteral nutrition.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* need mechanical ventilation for more than 2 days * mean blood pressure more than 60mmHg * predicted ICU stay more than 7 days * tolerance of parenteral or enteral nutrition
Exclusion criteria
* irreversible status of primary disease * any history of malnutrition before enrollment * history of steroid cortisol administration * severe liver dysfunction (Child-Pugh Score C) * pregnancy * refuse to enrollment * re-admission to ICU and has been enrolled during former admission to ICU
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| all cause mortality | 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU stay | patients enrolled will be followed for length of ICU stay, an expected average of 6 weeks | — |
| infection incidence rate | 28 days | 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. |
| Liver function and renal function | on 1st. day, 3rd. day, 7th. day, 14th. day, 21st. day, 28th. day after enrollment | Liver function is assessed through serum bilirubin and liver enzyme, renal function is assessed through serum urea nitrogen and creatinine. |
| duration on ventilators | patients enrolled will be followed for the duration of mechanical ventilation, an expcected average of 4 weeks | — |
| 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 | — |
| diameter of midpoint of musculus rectus femoris | on 28th. day or endpoint of the trial | diameter of the muscle is measured with percutaneous ultrasound |
Countries
China
Outcome results
None listed