An Observational Cohort Study to Establish Accurate Nutrition Therapy for Critically Ill Patients
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|ClinicalTrials.gov Identifier: NCT02831725|
Recruitment Status : Unknown
Verified July 2016 by Peking Union Medical College Hospital.
Recruitment status was: Not yet recruiting
First Posted : July 13, 2016
Last Update Posted : July 13, 2016
- 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
|Condition or disease|
|Nutrition Therapy for Critical Illness|
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2019|
- complications after the operation [ Time Frame: three years ]intestinal fistula, pancreatic fistula, biliary fistula and sepsis, bleeding, nosocomial infection
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831725
|Contact: Wei Chenfirstname.lastname@example.org|