Unknown statusInterventionalNot ApplicableUpdated Feb 7, 2020
An Observational Cohort Study to Establish Accurate Nutrition Therapy for Critically Ill Patients | NCT02831725 | Trialant
Unknown statusObservationalUpdated Jul 13, 2016
An Observational Cohort Study to Establish Accurate Nutrition Therapy for Critically Ill Patients
ClinicalTrials.gov ID
NCT02831725
Lead Sponsor
Peking Union Medical College HospitalOTHER
Overall Status
Unknown status
Study Type
Observational
Enrollment
120Estimated
Last Update Posted
Jul 13, 2016Estimated
Start Date
Jul 2016
Primary Completion Date
Jul 2019Estimated
Completion Date
Jul 2019Estimated
Brief Summary
Demographics data;
Nutritional evaluation data;
All biochemical monitoring data during the study period;
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.
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.
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.
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
Nutrition Therapy for Critical Illness
No interventions
There are no interventions for this study.
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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