ClinicalTrials.gov
ClinicalTrials.gov Menu

Nutritional Requirement for the Severe Trauma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01760135
Recruitment Status : Unknown
Verified January 2013 by Suk-Kyung, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : January 4, 2013
Last Update Posted : January 4, 2013
Sponsor:
Information provided by (Responsible Party):
Suk-Kyung, Asan Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
After severe trauma, high caloric nutrition supplement do harm on metabolic and immunologic aspects.

Condition or disease Intervention/treatment Phase
Trauma Dietary Supplement: high caloric nutritional supplement Dietary Supplement: low caloric nutritional supplement Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Nutritional Requirement for the Severe Trauma Patients
Study Start Date : November 2012
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 Measures :
  1. Mortality [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 week ]
  2. 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 ]
  3. Hospitals stays [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 week ]
  4. ICU stays [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 week ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013

Keywords provided by Suk-Kyung, Asan Medical Center:
trauma
nutrition
hyperglycemia

Additional relevant MeSH terms:
Wounds and Injuries