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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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9 January 2017 |
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Main ID: |
NCT02583880 |
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Date of registration:
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21/10/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Screening Day Latin America
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Scientific title:
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Screening Day Latin America to Assess Disease-related Malnutrition and Clinical Nutrition Practice in ICU Patients |
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Date of first enrolment:
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October 2015 |
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Target sample size:
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1162 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02583880 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Retrospective
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Phase:
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N/A
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Countries of recruitment
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Argentina
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Brazil
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Chile
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Colombia
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Ecuador
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Mexico
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Panama
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Peru
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Contacts
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Name:
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John F Stover, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fresenius Kabi Deutschland GmbH, Borkenberg 14, 61440 Oberursel, Germany |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Patients will be included if the following criteria are fulfilled:
- Critically ill adult (=18 years of age) patients, including critically ill major
gastrointestinal surgery patients
- Patient is hospitalized in Intensive Care Unit (ICU) on the Screening Day
- Patients receiving enteral nutrition (EN; tube feeding only) and/or parenteral
nutrition (PN) on the Screening Day and the day before the Screening Day
- Initiation of enteral nutrition (EN) and/or parenteral nutrition (PN) during ICU
admission and at least one day before the Screening Day
A critically ill patient is defined as a patient with at least one organ failure.
Exclusion Criteria:
The following patients are excluded from the documentation:
- Critically ill burn patients
- Patients on the Intensive Care Unit (ICU) for surveillance without needing enteral
nutrition (EN) and/or parenteral nutrition (PN)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Caloric Deficit
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Nutritional Status
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Malnutrition
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Primary Outcome(s)
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Caloric deficit on the day before the Screening Day
[Time Frame: On the day before the Screening Day (day -1)]
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Secondary Outcome(s)
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Cumulative caloric deficit on days -1 to -5 before the screening day
[Time Frame: Days -1 to -5]
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Current use of enteral and parenteral nutrition
[Time Frame: At Screening Day]
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Nutritional status of the patient
[Time Frame: The Screening Day (Day 0) and the day of admission to the Intensive Care Unit (ICU)]
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Secondary ID(s)
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NScr-001-CNI
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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