Nutritional Requirement for the Severe Trauma Patients

January 3, 2013 updated by: Suk-Kyung, Asan Medical Center
After severe trauma, high caloric nutrition supplement do harm on metabolic and immunologic aspects.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

61

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of antibiotics usage (days)
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 week).
participants will be followed for the duration of hospital stay, an expected average of 2 week).

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 week
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
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
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
participants will be followed for the duration of hospital stay, an expected average of 2 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Suk-Kyung Hong, MD, PhD., Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

November 1, 2013

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

December 21, 2012

First Submitted That Met QC Criteria

January 3, 2013

First Posted (Estimate)

January 4, 2013

Study Record Updates

Last Update Posted (Estimate)

January 4, 2013

Last Update Submitted That Met QC Criteria

January 3, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-001 (Other Grant/Funding Number: Meriter Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Trauma

Clinical Trials on high caloric nutritional supplement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe