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

NCT02831725 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2016-07-13

No results posted yet for this study

Summary

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

Conditions

  • Nutrition Therapy for Critical Illness

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Peking Union Medical College Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2019-07-31
Completion
2019-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02831725 on ClinicalTrials.gov