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Completed

NCT Number: NCT03807232

Predictive Factors, Demographics and Mortality for ARDS in Burn Patients

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

all patients treated at the Burns Intensive Care Unit (BICU) of the University Hospital Zurich (USZ) between January 2004 and December 2009.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. Clinical course of post-burn-ARDS

    Time frame: 6 years

    various clinical parameters related to the Outcome of post-burn-ARDS

  3. predictors of post-burn ARDS

    Time frame: 6 years

    To identify relevant predictors of post-burn ARDS, including the development of a prognostic score

Secondary outcomes

  1. to examine outcome parameter mortality

    Time frame: 6 years

    A retrospective analysis of 400 patients admitted to the Burns Intensive Care Unit of the University Hospital Zurich

  2. to examine outcome parameter hospital stay

    Time frame: 6 years

    A retrospective analysis of 400 patients admitted to the Burns Intensive Care Unit of the University Hospital Zurich

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 16, 2019
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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