surgical critical illness
Conditions
Interventions
low dose group:low dose of glutamine dipeptide
high dose group:high dose of glutamine dipeptide
Sponsors
Tenth People's Hospital of Tongji University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, 18 to 85 years old; 2. Surgical critically ill patients (APACHE II score more than at least 10); 3. Requires TPN because oral or enteral nutrition is not possible or contraindicated; 4. Has capability to complete at least 7 days of study treatment; 5. Has a useable central vein for IV delivery of TPN; 6. Institutional Review Board (IRB)-/ Independent Ethics Committee (IEC)-approved written informed consent has been signed.
Exclusion criteria
Exclusion criteria: 1. Has a life expectancy of shorter than 7 days from initiation of study treatment, in the opinion of the Investigator; 2. Patients with unstable vital sign; 3. APACHE II score more than 30; 4. Creatinine clearance less than 25ml/min; 5. Known serious clinically significant condition that would preclude participation in the study (e.g., congestive heart failure in New York Heart Association (NYHA) class IV) or severe renal insufficiency without adequate compensation (e.g., hemofiltration, hemodialysis, or peritoneal dialysis), etc.; 6. Known chronic active hepatitis, alanine aminotransferase (ALT) more than 4 x upper limit of normal (ULN), aspartate aminotransferase (AST) more than 4 x ULN, or total serum bilirubin more than 2*ULN; 7. Known history of human immunodeficiency virus infection; 8. Known congenital abnormalities of amino acid metabolism (e.g., phenylketonuria,maple syrup urine disease, homocystinuria, or tyrosinemia, etc.); 9. Known hypersensitivity to the components of either of the investigational study treatments; 10. Known severe dyslipidemia with triglyceride level more than 2*ULN or more than 4.52 mmol/L (more than 400 mg/dL); 11. Severe hyperglycemia, serum glucose more than 20 mmol/L (more than 360 mg/dL); 12. Known pregnancy or lactation; 13. Use of prohibited medications (e.g. glucocorticosteroids or antitumor chemotherapeutic agents) within 30 days prior to enrollment; 14. Any unsuitable subject in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| albumin;pre-albumin;transferrin;D lactic acid;Infection complications rate;The length of time in ICU;APACHE II score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Amino acid spectrum of blood;CD4/CD8;IgA;IgG;IgM;C-reactive protein;Intestinal fatty acid binding protein;Peripheral blood bacterial DNA fragments;The incidence of SISR;Mechanical ventilation time;cytokine; | — |
Countries
China
Contacts
Public ContactQin Huanlong
Outcome results
None listed