BurnsNCT04737148
Analysis and Accuracy of Mortality Prediction Scores
An observational study of Burns and Morality, run by Ministry of Health, Kuwait at 1 site in Kuwait.
Trial summary
Patients admitted to the ICU in a tertiary burn centre in Kuwait were analysed using multiple mortality prediction scores. The accuracy of these scores were compared to each other to ascertain which prediction modality provides the most accurate prognosis. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Mortality scores
- How many people
- 211 participants
- Where
- 1 siteKuwait
- Study dates
- 20 Feb 2020to 1 Nov 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients admitted to the ICBU between January 2017 to December 2019
Who may be able to join
- Pediatric burn patients with partial/full thickness burns>10% TBSA Adult patients with partial/full thickness burns >15% TBSA Patients with electric burns Patients iwth burns involving the voice Any patient with suspected inhalational injury Burn patients with significant comorbidities
Who cannot join
- Patients with incomplete data records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Analysis and Accuracy of Mortality Prediction Scores in Burn Patients Admitted to the Intensive Care Burn Unit (ICBU)
Patients admitted to the ICU in a tertiary burn centre in Kuwait were analysed using multiple mortality prediction scores. The accuracy of these scores were compared to each other to ascertain which prediction modality provides the most accurate prognosis.
Read the detailed description
The aim of this study is to determine the accuracy of three established scoring systems used for burn patients admitted to the intensive care unit and to determine the risk factors associated with poor outcomes.
A total of 211 patients with who were admitted to the ICBU in a tertiary care centre in Kuwait from January 2017 to December 2019 were analysed retrospectively. Data were collected using patient medical records. The FLAMES, BOBI and revised Baux scores were calculated, and the survivor and non-survivor scores of patients were analysed to determine the sensitivity, specificity and Area Under the Receiver Operating Characteristics (AUROC) of the different scoring modalities.
- Being tested
- Mortality scores
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mortality scoresOther
Revised Baux, BOBI and FLAMES scores
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve of the 3 aforementioned mortality prediction scores
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start20 Feb 2020
- Primary completion15 Apr 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Kuwait
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zakariya Hassan, Ministry of Health, Kuwait
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737148
- Sponsor's protocol ID
- 14422
- Status last verified
- Feb 2021
- First submitted
- 29 Jan 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analysis and Accuracy of Mortality Prediction Scores in Burn Patients Admitted to the Intensive Care Burn Unit (ICBU)
- ClinicalTrials.gov ID
- NCT04737148
- Acronym / sponsor ID
- 14422
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Ministry of Health, KuwaitOther government
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 3 Feb 2021 (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.
Patients admitted to the ICU in a tertiary burn centre in Kuwait were analysed using multiple mortality prediction scores. The accuracy of these scores were compared to each other to ascertain which prediction modality provides the most accurate prognosis.
Detailed description
The aim of this study is to determine the accuracy of three established scoring systems used for burn patients admitted to the intensive care unit and to determine the risk factors associated with poor outcomes.
A total of 211 patients with who were admitted to the ICBU in a tertiary care centre in Kuwait from January 2017 to December 2019 were analysed retrospectively. Data were collected using patient medical records. The FLAMES, BOBI and revised Baux scores were calculated, and the survivor and non-survivor scores of patients were analysed to determine the sensitivity, specificity and Area Under the Receiver Operating Characteristics (AUROC) of the different scoring modalities.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted to the ICBU between January 2017 to December 2019
Key inclusion criteria (1 listed)
- Pediatric burn patients with partial/full thickness burns>10% TBSA Adult patients with partial/full thickness burns >15% TBSA Patients with electric burns Patients iwth burns involving the voice Any patient with suspected inhalational injury Burn patients with significant comorbidities
Key exclusion criteria (1 listed)
- Patients with incomplete data records
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 |
|---|---|---|
| Mortality scoresRevised Baux, BOBI and FLAMES scores | Other | – |
Primary outcome
Area under curve of the 3 aforementioned mortality prediction scores
Time frame: 4 years
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 3 Feb 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns and Morality, run by Ministry of Health, Kuwait at 1 site in Kuwait.
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 1 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 3 Feb 2021. 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 Kuwait. 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.
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?
Area under curve of the 3 aforementioned mortality prediction scores (time frame: 4 years). 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 3 Feb 2021.