Nutritional Requirement for the Severe Trauma Patients

NCT ID: NCT01760135

Last Updated: 2013-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-11-30

Brief Summary

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

Detailed Description

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Conditions

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Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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low calory

15kcal/kg caloric supplement

Group Type EXPERIMENTAL

high caloric nutritional supplement

Intervention Type DIETARY_SUPPLEMENT

high caloric nutritional supplement (25kcal/kg)

high calory

25kcal/kg

Group Type ACTIVE_COMPARATOR

low caloric nutritional supplement

Intervention Type DIETARY_SUPPLEMENT

low caloric nutritional supplement(15kcal/kg)

Interventions

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high caloric nutritional supplement

high caloric nutritional supplement (25kcal/kg)

Intervention Type DIETARY_SUPPLEMENT

low caloric nutritional supplement

low caloric nutritional supplement(15kcal/kg)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Suk-Kyung

Director, Surgical Intensive Care Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suk-Kyung Hong, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Suk-Kyung Hong, MD., PhD.

Role: CONTACT

82-2-3010-5989

Facility Contacts

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Suk-Kyung Hong, MD., PhD.

Role: primary

82-2-3010-5989

Other Identifiers

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2012-001

Identifier Type: -

Identifier Source: org_study_id

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