Back to resultsNutritional Requirement for the Severe Trauma Patients
Primary Purpose
Trauma
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
high caloric nutritional supplement
low caloric nutritional supplement
Sponsored by
About this trial
This is an interventional supportive care trial for Trauma focused on measuring trauma, nutrition, hyperglycemia
Eligibility Criteria
Inclusion Criteria:
- ISS more than 15 score
- older than 20 years old
- patient who need parenteral nutrition more than 5 days
Exclusion Criteria:
- patients who have metabolic disease except for diabetes
- patients who cannot resuscitated
- very low body weight (< 40kg)
Sites / Locations
- Asan Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
low calory
high calory
Arm Description
15kcal/kg caloric supplement
25kcal/kg
Outcomes
Primary Outcome Measures
Duration of antibiotics usage (days)
Secondary Outcome Measures
Mortality
Number of date when is showing hyperglycemia (more than 200mg/dL)
Hospitals stays
ICU stays
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01760135
Brief Title
Nutritional Requirement for the Severe Trauma Patients
Official Title
Nutritional Requirement for the Severe Trauma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
November 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
After severe trauma, high caloric nutrition supplement do harm on metabolic and immunologic aspects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma
Keywords
trauma, nutrition, hyperglycemia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
low calory
Arm Type
Experimental
Arm Description
15kcal/kg caloric supplement
Arm Title
high calory
Arm Type
Active Comparator
Arm Description
25kcal/kg
Intervention Type
Dietary Supplement
Intervention Name(s)
high caloric nutritional supplement
Intervention Description
high caloric nutritional supplement (25kcal/kg)
Intervention Type
Dietary Supplement
Intervention Name(s)
low caloric nutritional supplement
Intervention Description
low caloric nutritional supplement(15kcal/kg)
Primary Outcome Measure Information:
Title
Duration of antibiotics usage (days)
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 week).
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 week
Title
Number of date when is showing hyperglycemia (more than 200mg/dL)
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 week
Title
Hospitals stays
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 week
Title
ICU stays
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ISS more than 15 score
older than 20 years old
patient who need parenteral nutrition more than 5 days
Exclusion Criteria:
patients who have metabolic disease except for diabetes
patients who cannot resuscitated
very low body weight (< 40kg)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suk-Kyung Hong, MD., PhD.
Phone
82-2-3010-5989
Email
skhong94@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suk-Kyung Hong, MD, PhD.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suk-Kyung Hong, MD., PhD.
Phone
82-2-3010-5989
Email
skhong94@amc.seoul.kr
12. IPD Sharing Statement
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Nutritional Requirement for the Severe Trauma Patients
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