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Nutritional Requirement for the Severe Trauma Patients

This study is currently recruiting participants.
Verified January 2013 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Suk-Kyung, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01760135
First received: December 21, 2012
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Trauma
 Dietary Supplement: high caloric nutritional supplement
Dietary Supplement: low caloric nutritional supplement
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Nutritional Requirement for the Severe Trauma Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Duration of antibiotics usage (days) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 week). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 week ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Hospitals stays [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 week ] [ Designated as safety issue: Yes ]
  • ICU stays [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 61
Study Start Date: November 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: low calory
15kcal/kg caloric supplement
 Dietary Supplement: high caloric nutritional supplement
high caloric nutritional supplement (25kcal/kg)
Active Comparator: high calory
25kcal/kg
 Dietary Supplement: low caloric nutritional supplement
low caloric nutritional supplement(15kcal/kg)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760135

Contacts
Contact: Suk-Kyung Hong, MD., PhD. 82-2-3010-5989 skhong94@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Suk-Kyung Hong, MD., PhD.     82-2-3010-5989     skhong94@amc.seoul.kr    
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Suk-Kyung Hong, MD, PhD. Asan Medical Center
  More Information

No publications provided

Responsible Party: Suk-Kyung, Director, Surgical Intensive Care Unit, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01760135     History of Changes
Other Study ID Numbers: 2012-001
Study First Received: December 21, 2012
Last Updated: January 3, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
trauma
nutrition
hyperglycemia

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013