Nutritional Requirement for the Severe Trauma Patients

Trauma Clinical Trial

Official title:

Nutritional Requirement for the Severe Trauma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01760135
• Other study ID #: 2012-001
• Status: Recruiting
• Phase: Phase 3
• First received: December 21, 2012
• Last updated: January 3, 2013
• Start date: November 2012
• Est. completion date: November 2013

Study information

• Verified date: January 2013
• Source: Asan Medical Center
• Contact: Suk-Kyung Hong, MD., PhD.
• Phone: 82-2-3010-5989
• Email: skhong94[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 61
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Trauma
• Wounds and Injuries

Intervention

Dietary Supplement:
• high caloric nutritional supplement
high caloric nutritional supplement (25kcal/kg)
• low caloric nutritional supplement
low caloric nutritional supplement(15kcal/kg)

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of antibiotics usage (days)		participants will be followed for the duration of hospital stay, an expected average of 2 week).	Yes
Secondary	Mortality		participants will be followed for the duration of hospital stay, an expected average of 2 week	Yes
Secondary	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	Yes
Secondary	Hospitals stays		participants will be followed for the duration of hospital stay, an expected average of 2 week	Yes
Secondary	ICU stays		participants will be followed for the duration of hospital stay, an expected average of 2 week	Yes