Critical illness
Conditions
Interventions
Experimental group:Continuous infusion of standard 18AA-VII
Control group:Nursing of the ICU treatment team
Sponsors
Jinling Hospital affiliated to Nanjing University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Informed consent form obtained from the patient or next of kin; 2. Aged >= 18 years; 3. Within 48h of ICU admission; 4. APACHEII score 15 or more; 5. Have a working central venous access line through which the study intervention could be delivered; 6. Be able to tolerate at least 1L of fluid volume per day.
Exclusion criteria
Exclusion criteria: 1.Patients is currently receiving an selective COX-2 inhibitors; 2.Patients receiving palliative treatment or expected to die within 48 hours; 3.Have severe Acute Kidney Injury, defined as: current serum creatinine (SCr) increased 3 times pre-acute illness value OR SCr > 350 µmol/L with recent increase greater than 44 µmol/L. [Note: If pre-acute illness creatinine values are unknown, assume upper limit of normal: 90 µmol/L for females and 110 µmol/L for males.] 4.Patients with malignant diseases receiving radiotherapy or chemotherapy; 5.Currently receiving or scheduled for dialysis/renal replacement therapy; 6.Patients ever had a kidney transplant; 7.Patients require treatment of a burn injury to greater than 20% of total body surface area; 8.Patients have a documented contraindication to the study intervention (IV amino acids); 9.Known to be pregnant or currently breastfeeding; 10.Have severe liver disease (Biopsy proven cirrhosis, or documented portal hypertension with a known past history of either upper GI bleeding attributed to portal hypertension or of hepatic failure leading to encephalopathy / coma); 11.Have a documented hypersensitivity (known allergy) to one or more of the included amino acids; 12.Have a documented inborn error of amino acid metabolism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| all-cause mortality at day 90 after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time from Intensive care unit admission to feeding start;Time from study enrolment to feeding start;Number of days of supplementary protein in patients allocated to receive the study intervention;Mean nutrition support days;Percent of patients who were never fed;Mean energy;Incidence of clinically significant renal dysfunction (proportion of patients per study arm);Days of Renal Replacement Therapy (RRT);Incidence of RRT (proportion of patients per study arm);Continuing need for RRT at Study Day 90 (proportion of patients per study arm);New onset organ failure within first 7 days after randomization;New receipt of organ support therapy within first 7 days after randomization; | — |
Countries
China
Contacts
Public ContactLi Weiqin
Jinling Hospital affiliated to Nanjing University
Outcome results
None listed