Nutrition Therapy for Critical Illness Clinical Trial
1. Demographics data;
2. Nutritional evaluation data;
3. All biochemical monitoring data during the study period;
4. All nutritional treatment data will be recorded daily during the study period,
including actual calorie intake, protein intake, and the proportion of calorie/protein
administered by EN and/or PN route. The nutritional treatment protocol will be decided
by the attending physician, the investigator will not intervene.
5. A blood sample (5 ml) will be drawn from every patient immediately after they enroll
into the study, and the metabolomics of the samples will be analyzed analysis using a
combined 800 MHz 1H-NMR-UPLC-MS system. The data will then be used to establish
metabolic profile baseline.
6. We will establish a sub-group that contains 20 patients (chosen from enrolled patients
according to APACHE II scores: 10 patients are APACHE II scores in 21-30). We will take
one blood sample daily during the whole study period. The plasma sample will be used
for metabolomics analysis using an 800 MHz 1H-NMR-UPLC-MS system. And the data will be
used for metabolic dynamic modeling.
7. Clinical outcomes data, which include: 1) Complications after the operation (intestinal
fistula, pancreatic fistula, biliary fistula and sepsis, bleeding, nosocomial
infection); 2) death event; 3) ICU-stay; 4) Length of hospitalization
| Status | Not yet recruiting |
| Enrollment | 120 |
| Est. completion date | July 2019 |
| Est. primary completion date | July 2019 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - age: 18-70 - patients are underwent Whipple operation or subtotal gastrectomy and ever admitted to intensive care unit (ICU) after the operation - receive parenteral or enteral nutrition > 3 days Exclusion Criteria: - has metabolic disorders: diabetes, thyroid disease - Pregnant or breastfeeding - The presence of drug or alcohol dependence - The presence of tuberculosis, HIV infection and other acute infectious disease - Serious liver, kidney, heart and other vital organ failure |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Peking Union Medical College Hospital | Baxter Healthcare Corporation |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | complications after the operation | intestinal fistula, pancreatic fistula, biliary fistula and sepsis, bleeding, nosocomial infection | three years | No |