TraumaPhase 3NCT01760135
Nutritional Requirement for the Severe Trauma Patients
A Phase 3 study testing high caloric nutritional supplement and low caloric nutritional supplement in people with Trauma, run by Asan Medical Center at 1 site in South Korea.
Trial summary
After severe trauma, high caloric nutrition supplement do harm on metabolic and immunologic aspects. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Trauma
- What is being tested?
- high caloric nutritional supplement and low caloric nutritional supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2012to Nov 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ISS more than 15 score
- older than 20 years old
- patient who need parenteral nutrition more than 5 days
Who cannot join
- patients who have metabolic disease except for diabetes
- patients who cannot resuscitated
- very low body weight (< 40kg)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 138-736
Suk-Kyung Hong, MD., PhD., 82-2-3010-5989, skhong94@amc.seoul.kr
About this study
After severe trauma, high caloric nutrition supplement do harm on metabolic and immunologic aspects.
- Conditions
- Trauma
- Being tested
- high caloric nutritional supplement, low caloric nutritional supplement
- Keywords
- trauma, nutrition, hyperglycemia
- Medical subject headings
- Wounds and Injuries, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high caloric nutritional supplementDietary supplement
high caloric nutritional supplement (25kcal/kg)
low caloric nutritional supplementDietary supplement
low caloric nutritional supplement(15kcal/kg)
| Study group | Role | What they receive |
|---|---|---|
| low calory | Experimental | 15kcal/kg caloric supplement Receives: Dietary Supplement: high caloric nutritional supplement |
| high calory | Active comparator | 25kcal/kg Receives: Dietary Supplement: low caloric nutritional supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of antibiotics usage (days)
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 week).
Secondary outcomes (4)
Mortality
Measured: 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)
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 week
Hospitals stays
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 week
ICU stays
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suk-Kyung, Asan Medical Center
- Investigators
- Suk-Kyung Hong, MD, PhD., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760135
- Sponsor's protocol ID
- 2012-001
- Status last verified
- Jan 2013
- First submitted
- 21 Dec 2012
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Requirement for the Severe Trauma Patients
- ClinicalTrials.gov ID
- NCT01760135
- Acronym / sponsor ID
- 2012-001
- Conditions
- Trauma
- Keywords
- trauma, nutrition, hyperglycemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After severe trauma, high caloric nutrition supplement do harm on metabolic and immunologic aspects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low calory | Experimental | Dietary Supplement: high caloric nutritional supplement15kcal/kg caloric supplement |
| high calory | Active comparator | Dietary Supplement: low caloric nutritional supplement25kcal/kg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ISS more than 15 score
- older than 20 years old
- patient who need parenteral nutrition more than 5 days
Key exclusion criteria (3 listed)
- patients who have metabolic disease except for diabetes
- patients who cannot resuscitated
- very low body weight (< 40kg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high caloric nutritional supplementhigh caloric nutritional supplement (25kcal/kg) | Dietary supplement | low calory |
| low caloric nutritional supplementlow caloric nutritional supplement(15kcal/kg) | Dietary supplement | high calory |
Primary outcome
Duration of antibiotics usage (days)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 week).
4 secondary outcomes
Mortality
Time frame: 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
Hospitals stays
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suk-Kyung Hong, MD, PhD. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing high caloric nutritional supplement and low caloric nutritional supplement in people with Trauma, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suk-Kyung Hong, MD., PhD. (82-2-3010-5989, skhong94@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of antibiotics usage (days) (time frame: participants will be followed for the duration of hospital stay, an expected average of 2 week).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2013.