Nutritional Requirement for the Severe Trauma Patients

Phase 3

• Conditions: Trauma
• Interventions: Dietary Supplement: low caloric nutritional supplement; Dietary Supplement: high caloric nutritional supplement

• Registration Number: NCT01760135
• Lead Sponsor: Asan Medical Center

Brief Summary

After severe trauma, high caloric nutrition supplement do harm on metabolic and immunologic aspects.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-12-21
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-03
• Last Update Submitted: 2013-01-03
• Study First Posted: 2013-01-04
• Last Update Posted: 2013-01-04
• Primary Completion: 2013-11
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 61

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high calory	low caloric nutritional supplement	25kcal/kg
low calory	high caloric nutritional supplement	15kcal/kg caloric supplement

Primary Outcome Measures

Name	Time	Method
Duration of antibiotics usage (days)	participants will be followed for the duration of hospital stay, an expected average of 2 week).

Secondary Outcome Measures

Name	Time	Method
Mortality	participants will be followed for the duration of hospital stay, an expected average of 2 week
Number of date when is showing hyperglycemia (more than 200mg/dL)	participants will be followed for the duration of hospital stay, an expected average of 2 week
Hospitals stays	participants will be followed for the duration of hospital stay, an expected average of 2 week
ICU stays	participants will be followed for the duration of hospital stay, an expected average of 2 week

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of