Nutritional Requirement for the Severe Trauma Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified January 2013 by Suk-Kyung, 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 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:

MedlinePlus related topics: Dietary Supplements Wounds and Injuries

U.S. FDA Resources

Further study details as provided by Suk-Kyung, 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). ]

Secondary Outcome Measures:

Mortality [ Time Frame: 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) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 week ]
Hospitals stays [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 week ]
ICU stays [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 week ]


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 (Adult, Senior)
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

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


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

Keywords provided by Suk-Kyung, Asan Medical Center:


trauma nutrition hyperglycemia

Additional relevant MeSH terms:


Wounds and Injuries

ClinicalTrials.gov processed this record on June 23, 2017

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