NCT01760135

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
61

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

January 4, 2013

Status Verified

January 1, 2013

Enrollment Period

1 year

First QC Date

December 21, 2012

Last Update Submit

January 3, 2013

Conditions

Trauma

Keywords

traumanutritionhyperglycemia

Outcome Measures

Primary Outcomes (1)

  • Duration of antibiotics usage (days)

    participants will be followed for the duration of hospital stay, an expected average of 2 week).

Secondary Outcomes (4)

  • Mortality

    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)

    participants will be followed for the duration of hospital stay, an expected average of 2 week

  • Hospitals stays

    participants will be followed for the duration of hospital stay, an expected average of 2 week

  • ICU stays

    participants will be followed for the duration of hospital stay, an expected average of 2 week

Study Arms (2)

low calory

EXPERIMENTAL

15kcal/kg caloric supplement

Dietary Supplement: high caloric nutritional supplement

high calory

ACTIVE COMPARATOR

25kcal/kg

Dietary Supplement: low caloric nutritional supplement

Interventions

high caloric nutritional supplementDIETARY_SUPPLEMENT

high caloric nutritional supplement (25kcal/kg)

low calory
low caloric nutritional supplementDIETARY_SUPPLEMENT

low caloric nutritional supplement(15kcal/kg)

high calory

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ISS more than 15 score
  • older than 20 years old
  • patient who need parenteral nutrition more than 5 days

You may not qualify if:

  • patients who have metabolic disease except for diabetes
  • patients who cannot resuscitated
  • very low body weight (\< 40kg)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

MeSH Terms

Conditions

Wounds and InjuriesHyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Suk-Kyung Hong, MD, PhD.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suk-Kyung Hong, MD., PhD.

CONTACT

82-2-3010-5989skhong94@amc.seoul.kr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Surgical Intensive Care Unit

Study Record Dates

First Submitted

December 21, 2012

First Posted

January 4, 2013

Study Start

November 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

January 4, 2013

Record last verified: 2013-01

Locations

KR(1)