Nutritional Requirement for the Severe Trauma Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2013 by Asan Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Asan Medical Center
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
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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 Endpoint Classification: Efficacy Study 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:
Further study details as provided by 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). ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Mortality [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 week ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- Hospitals stays [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 week ] [ Designated as safety issue: Yes ]
- ICU stays [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 week ] [ Designated as safety issue: Yes ]
| 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) |
| Genders Eligible for Study: | Both |
| 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
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 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by Asan Medical Center:
|
trauma nutrition hyperglycemia |
Additional relevant MeSH terms:
|
Wounds and Injuries |
ClinicalTrials.gov processed this record on September 29, 2016