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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief 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

Condition or disease
Nutrition Therapy for Critical Illness

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : July 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. complications after the operation [ Time Frame: three years ]
    intestinal fistula, pancreatic fistula, biliary fistula and sepsis, bleeding, nosocomial infection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
hospitalized adult patients
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

Information from the National Library of Medicine

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


Contacts
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Contact: Wei Chen 8613911006820 txchenwei@sina.com

Sponsors and Collaborators
Peking Union Medical College Hospital
Baxter Healthcare Corporation

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02831725    
Other Study ID Numbers: HS-991
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes