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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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17 November 2015 |
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Main ID: |
NCT02577211 |
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Date of registration:
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10/10/2015 |
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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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Hypocaloric Enteral Nutrition in the Critically Ill Patient
hipoentnut |
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Scientific title:
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Randomized Controlled Trial of Hypocaloric Hyperproteic Enteral Nutrition in the Critically Ill Patient |
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Date of first enrolment:
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December 2013 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02577211 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Colombia
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Contacts
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Name:
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Saul J Rugeles, 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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Hospital Universitario San Ignacio |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- >18 years
- Estimated fasting period of at least 96 hours
- ICU patients
Exclusion Criteria:
- Parenteral nutrition
- Pregnancy
- Diabetes
- Liver failure
- Transplantation or in transplant protocol
- Previous nutrition support
- Chronic Renal failure
Age minimum:
18 Years
Age maximum:
120 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Critically Ill
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Intervention(s)
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Dietary Supplement: Hipocaloric enteral nutrition
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Dietary Supplement: Normocaloric enteral nutrition
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Primary Outcome(s)
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Change in the intial SOFA (Sequential Organ Failure Assessment) score at 48 hours.
[Time Frame: 48 hours after the onset of nutrition]
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Secondary Outcome(s)
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Number of days the patient requires mechanical ventilation.
[Time Frame: Within the first 28 days after the onset of nutrition]
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Mortality to 28 days
[Time Frame: 28 days after the onset of nutrition]
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Units of insulin require in a day
[Time Frame: Within the first 4 days after the onset of nutrition]
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Number of days in the intensive care unit
[Time Frame: Within the first 28 days after the onset of nutrition]
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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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