An Observational Cohort Study to Establish Accurate Nutrition Therapy for Critically Ill Patients

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

Study Overview

• Status: Unknown
• Conditions: Nutrition Therapy for Critical Illness

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Wei Chen; Phone Number: 8613911006820; Email: txchenwei@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

hospitalized adult patients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications after the operation	intestinal fistula, pancreatic fistula, biliary fistula and sepsis, bleeding, nosocomial infection	three years

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimate): July 13, 2016

Study Record Updates

• Last Update Posted (Estimate): July 13, 2016
• Last Update Submitted That Met QC Criteria: July 11, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: HS-991