Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Nutritional Requirement for the Severe Trauma Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2013 by Asan Medical Center.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on February 27, 2015