Malnutrition in Critically ill patients
Conditions
Interventions
Control group:administrated with parenteral nutrition on the basis of 20% Lipovenoes for at least 5 days
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. ICU patients aged between 18 – 80 years (inclusively), male and female adults; 2. The start of the study drug administration should be less than 1 week after ICU admission; 3. APACHE II scores between 10 - 23 (assessed within 24h at ICU admission); 4. Modified NUTRIC score =5; 5. Oral nutrition or enteral nutrition (EN) unfeasible, or EN cannot reach 30% of daily energy, expected to require TPN or PN + EN for at least 5 days; during the study, calorie intake from PN = 600kcal/day, = 70% of total calorie intake is also expected; 6. Agreed to participate in the study with signed informed consent form by patient or legal representative.
Exclusion criteria
Exclusion criteria: 1. Serious persisting hemodynamic instability unresponsive to corrective measures (defined as requiring high dosage of fluid resuscitation or vasoactive agents to maintain blood pressure; high dosage of fluid resuscitation refers to fluid resuscitation dosage = 10ml/kg crystal liquid within 1 h (or considerable volume of colloidal solution); high dosage of vasoactive agents refers to norepinephrine dosage > 0.5 ug/kg/min or adrenaline dosage > 0.5 ug/kg/min or dopamine dosage > 15 ug/kg/min); 2. BMI 28 kg/m2; 3. Severe ARDS at admission (PaO2/FiO2 4mg/dL (or 353.6µmol/L); (2) Regular peritoneal dialysis or hemodialysis; 6. Serious acquired or congenital hypertriglyceridemia: triglycerides = 4.5mmol/L (or 400mg/dl); 7. Receive TPN for 3 consecutive days within 1 week before the present study; 8. Undergone chemotherapy or radiotherapy within 1 month before the present study; 9. Serious chronic neurological disorders, such as Experienced cerebrovascular accident with persisting neurological deficit within the previous 6 months; 10. Burns or acute inhalational injury Patients; 11. The patient has participated in other interventional clinical study within 4 weeks before the present study; 12. Known to be allergic to any composition of the study PN solution; 13. The patients who are not qualified for the present study as per the judgment of the investigator such as pregnant or lactating or general contraindications for infusion, and so on.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| New-onset nosocomial Infection in ICU;T lymphocyte subsets level;peripheral blood lymphocyte count;C Reactive Protein;IL-1ß;IL-10;TNF-a;Malonyldialdehyde;superoxide dismutase;Change in SOFA scores from baseline to treatment day 6;Infection-free duration;Antibiotics-free days;Change of IL-6 from baseline to day 6;Area under curve of IL-6 from baseline to treatment day 6;Vital signs;Oxygenation index;liver and renal function;Lipid profile;Blood glucose;Total calorie intake;total calorie intake from parenteral nutrition;daily calorie intake from parenteral nutrition;Calorie intake from parenteral nutrition/total calorie intake;Duration of total parenteral nutrition (day);Calorie intake from enteral nutrition;Free-mechanical ventilation time;Length of ICU stay;Length of hospital stay;Mortality within 28 days;Incidence of Sepsis;Incidence of septic shock;Cost of ICU stay;Overall cost of hospital stay;routine coagulation examinations; | — |
Primary
| Measure | Time frame |
|---|---|
| IL-6; | — |
Countries
China
Contacts
Public ContactXiangdong Guan
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed