ARDS, HumanNCT03807232
Predictive Factors, Demographics and Mortality for ARDS in Burn Patients
An observational study of ARDS, Human and Burns, run by University of Zurich.
Trial summary
This retrospective study characterizes the clinical course and identifies four independent predictors of Acute Respiratory Distress Syndrome (ARDS) after burn injury (post-burn ARDS; pbARDS). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- ARDS, Human, Burns, Lung Diseases
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 26 Aug 2010to 23 May 2013
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients treated at the Burns Intensive Care Unit (BICU) of the University Hospital Zurich (USZ) between January 2004 and December 2009
Who may be able to join
- all patients treated at the Burns Intensive Care Unit (BICU) of the University Hospital Zurich (USZ) between January 2004 and December 2009.
Who cannot join
- Exclusions were made because of incomplete or unavailable data, re-hospitalization due to complications of previous burns, and the initial decision not to resuscitate due to unfavorable prognosis.
About this study
This retrospective study characterizes the clinical course and identifies four independent predictors of Acute Respiratory Distress Syndrome (ARDS) after burn injury (post-burn ARDS; pbARDS). In addition, a clinically useful prognostic score for pbARDS is introduced (ARDS burn score), which was derived from these independent predictors. The newly developed score may be helpful for the development of specific treatment strategies.
Read the detailed description
Rationale:
Acute Respiratory Distress Syndrome (ARDS) after burn injury (post-burn ARDS; pbARDS) is a severe complication associated with a mortality of up to 44%. To date, only few studies have been published on the clinical course and predictive factors of pbARDS.
Objectives:
To characterize the clinical course of pbARDS, to identify relevant predictors, including the development of a prognostic score, and to examine outcome parameters such as mortality and hospitalization days.
Methods:
A retrospective analysis of 400 patients admitted to the Burns Intensive Care Unit of the University Hospital Zurich from 2004 to 2009 was performed. Multivariate logistic regression was used to determine independent risk factors for pbARDS. A prognostic score was developed, which was tested with leave-one-out-cross-validation and Receiver Operating Characteristic (ROC) curves.
- Conditions
- ARDS, Human, Burns, Lung Diseases
- Keywords
- ARDS, Human, Burns, Lung Diseases, Risk Factors, Retrospective Studies, Decision Support Techniques
- Medical subject headings
- Respiratory Distress Syndrome, Burns, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pbARDS | Burn patients who developed post-burn ARDS | |
| No pbARDS | Burn patients without development of post-burn ARDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-burn ARDS
Number of patients who developed post-burn ARDS among 400 Patients admitted to Burns Intensive Care Unit of University Hospital Zurich
Measured: 6 years
Clinical course of post-burn-ARDS
various clinical parameters related to the Outcome of post-burn-ARDS
Measured: 6 years
predictors of post-burn ARDS
To identify relevant predictors of post-burn ARDS, including the development of a prognostic score
Measured: 6 years
Secondary outcomes (2)
to examine outcome parameter mortality
A retrospective analysis of 400 patients admitted to the Burns Intensive Care Unit of the University Hospital Zurich
Measured: 6 years
to examine outcome parameter hospital stay
A retrospective analysis of 400 patients admitted to the Burns Intensive Care Unit of the University Hospital Zurich
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start26 Aug 2010
- Primary completion23 May 2013
- Study completion23 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pietro Giovanoli, Prof. Dr. med., Study chair, Universitätsspital Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807232
- Sponsor's protocol ID
- ARDS in Burn Patients USZ
- Status last verified
- Jan 2019
- First submitted
- 13 Sep 2018
- Last updated
- 16 Jan 2019
- 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 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors, Demographics and Mortality for ARDS in Burn Patients
- ClinicalTrials.gov ID
- NCT03807232
- Acronym / sponsor ID
- ARDS in Burn Patients USZ
- Conditions
- ARDS, Human, Burns, Lung Diseases
- Keywords
- ARDS, Human, Burns, Lung Diseases, Risk Factors, Retrospective Studies, Decision Support Techniques
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 26 Aug 2010 (actual)
- Primary completion
- 23 May 2013 (actual)
- Study completion
- 23 May 2013 (actual)
- First posted
- 16 Jan 2019 (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.
This retrospective study characterizes the clinical course and identifies four independent predictors of Acute Respiratory Distress Syndrome (ARDS) after burn injury (post-burn ARDS; pbARDS). In addition, a clinically useful prognostic score for pbARDS is introduced (ARDS burn score), which was derived from these independent predictors. The newly developed score may be helpful for the development of specific treatment strategies.
Detailed description
Rationale:
Acute Respiratory Distress Syndrome (ARDS) after burn injury (post-burn ARDS; pbARDS) is a severe complication associated with a mortality of up to 44%. To date, only few studies have been published on the clinical course and predictive factors of pbARDS.
Objectives:
To characterize the clinical course of pbARDS, to identify relevant predictors, including the development of a prognostic score, and to examine outcome parameters such as mortality and hospitalization days.
Methods:
A retrospective analysis of 400 patients admitted to the Burns Intensive Care Unit of the University Hospital Zurich from 2004 to 2009 was performed. Multivariate logistic regression was used to determine independent risk factors for pbARDS. A prognostic score was developed, which was tested with leave-one-out-cross-validation and Receiver Operating Characteristic (ROC) curves.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pbARDS | – | –Burn patients who developed post-burn ARDS |
| No pbARDS | – | –Burn patients without development of post-burn ARDS |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients treated at the Burns Intensive Care Unit (BICU) of the University Hospital Zurich (USZ) between January 2004 and December 2009
Key inclusion criteria (1 listed)
- all patients treated at the Burns Intensive Care Unit (BICU) of the University Hospital Zurich (USZ) between January 2004 and December 2009.
Key exclusion criteria (1 listed)
- Exclusions were made because of incomplete or unavailable data, re-hospitalization due to complications of previous burns, and the initial decision not to resuscitate due to unfavorable prognosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of post-burn ARDS
Time frame: 6 years
Number of patients who developed post-burn ARDS among 400 Patients admitted to Burns Intensive Care Unit of University Hospital Zurich
Clinical course of post-burn-ARDS
Time frame: 6 years
various clinical parameters related to the Outcome of post-burn-ARDS
predictors of post-burn ARDS
Time frame: 6 years
To identify relevant predictors of post-burn ARDS, including the development of a prognostic score
2 secondary outcomes
to examine outcome parameter mortality
Time frame: 6 years
to examine outcome parameter hospital stay
Time frame: 6 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 16 Jan 2019.
- 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.
Pietro Giovanoli, Prof. Dr. med. study chair
Universitätsspital Zürich
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS, Human and Burns, run by University of Zurich.
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 16 Jan 2019. 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?
Incidence of post-burn ARDS (time frame: 6 years). The study lists 3 primary outcomes in all. 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 16 Jan 2019.