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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02831725
Enrollment
120
Registered
2016-07-13
Start date
2016-07-31
Completion date
2019-07-31
Last updated
2016-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition Therapy for Critical Illness

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

Interventions

None listed

Sponsors

Baxter Healthcare Corporation
CollaboratorINDUSTRY
Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
complications after the operationthree yearsintestinal fistula, pancreatic fistula, biliary fistula and sepsis, bleeding, nosocomial infection

Contacts

Primary ContactWei Chen
txchenwei@sina.com8613911006820

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026