Predictive Factors, Demographics and Mortality for ARDS in Burn Patients

Completed

• Conditions: ARDS, Human; Burns; Lung Diseases

• Registration Number: NCT03807232
• Lead Sponsor: University of Zurich

Brief 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). 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 Timeline

• Study Start: 2010-08-26
• Primary Completion: 2013-05-23
• Study Completion: 2013-05-23
• Study First Submitted: 2018-09-13
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-15
• Last Update Submitted: 2019-01-15
• Study First Posted: 2019-01-16
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of post-burn ARDS	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	6 years	various clinical parameters related to the Outcome of post-burn-ARDS
predictors of post-burn ARDS	6 years	To identify relevant predictors of post-burn ARDS, including the development of a prognostic score

Secondary Outcome Measures

Name	Time	Method
to examine outcome parameter mortality	6 years	A retrospective analysis of 400 patients admitted to the Burns Intensive Care Unit of the University Hospital Zurich
to examine outcome parameter hospital stay	6 years	A retrospective analysis of 400 patients admitted to the Burns Intensive Care Unit of the University Hospital Zurich