Severe BurnNCT03379116
A Study on Nutrition Support in Adult Patients With Severe Burns
An observational study of Severe Burn and Enternal Nutrition, run by Southeast University, China.
Trial summary
To delineate nutritional support in adults patients with severe burns to investigate associations between nutritional practice and clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Burn, Enternal Nutrition
- What is being tested?
- enteral nutrition and parenteral nutrition
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2014to 2 Oct 2014
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study was a prospective, observational, multicenter trial and was conducted in intensive care units of seven hospitals participating in the treatment of the burn patients. Patients who were at least 18 years of age were eligible if they were expected to survive more than 48 hours.
Who may be able to join
- Patients were at least 18 years of age
- Patients were expected to survive more than 48 hours.
Who cannot join
- irreversible disease
About this study
To delineate nutritional support in adults patients with severe burns to investigate associations between nutritional practice and clinical outcomes.
- Conditions
- Severe Burn, Enternal Nutrition
- Being tested
- enteral nutrition and parenteral nutrition
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral nutrition and parenteral nutritionOther
In the treatment of the burned patients injured,data on nutritional support and patient's outcomes were collected and analyzed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 28 days
Daily data were recorded for a maximum of 28 days per patient. Patients alive in hospital at the 28th day or discharged prior to 28 days were considered to be survivors.
Measured: 28days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start2 Jun 2014
- Primary completion24 Sep 2014
- Study completion2 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe BurnStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379116
- Sponsor's protocol ID
- 20171215
- Status last verified
- Dec 2017
- First submitted
- 15 Dec 2017
- Last updated
- 21 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Nutrition Support in Adult Patients With Severe Burns
- ClinicalTrials.gov ID
- NCT03379116
- Acronym / sponsor ID
- 20171215
- Conditions
- Severe Burn, Enternal Nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 2 Jun 2014 (actual)
- Primary completion
- 24 Sep 2014 (actual)
- Study completion
- 2 Oct 2014 (actual)
- First posted
- 20 Dec 2017 (actual)
- 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.
To delineate nutritional support in adults patients with severe burns to investigate associations between nutritional practice and clinical outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study was a prospective, observational, multicenter trial and was conducted in intensive care units of seven hospitals participating in the treatment of the burn patients. Patients who were at least 18 years of age were eligible if they were expected to survive more than 48 hours.
Key inclusion criteria (2 listed)
- Patients were at least 18 years of age
- Patients were expected to survive more than 48 hours.
Key exclusion criteria (1 listed)
- irreversible disease
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 |
|---|---|---|
| enteral nutrition and parenteral nutritionIn the treatment of the burned patients injured,data on nutritional support and patient's outcomes were collected and analyzed. | Other | – |
Primary outcome
Mortality at 28 days
Time frame: 28days
Daily data were recorded for a maximum of 28 days per patient. Patients alive in hospital at the 28th day or discharged prior to 28 days were considered to be survivors.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Burn and Enternal Nutrition, run by Southeast University, China.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 21 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at 28 days (time frame: 28days). 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 21 Dec 2017.