NCT03807232

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 26, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2013

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

2.7 years

First QC Date

September 13, 2018

Last Update Submit

January 15, 2019

Conditions

ARDS, HumanBurnsLung Diseases

Keywords

ARDS, HumanBurnsLung DiseasesRisk FactorsRetrospective StudiesDecision Support Techniques

Outcome Measures

Primary Outcomes (3)

  • 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

    6 years

  • Clinical course of post-burn-ARDS

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

    6 years

  • predictors of post-burn ARDS

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

    6 years

Secondary Outcomes (2)

  • to examine outcome parameter mortality

    6 years

  • to examine outcome parameter hospital stay

    6 years

Study Arms (2)

pbARDS

Burn patients who developed post-burn ARDS

No pbARDS

Burn patients without development of post-burn ARDS

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Distress SyndromeBurnsLung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesRespiration DisordersWounds and Injuries

Study Officials

  • Pietro Giovanoli, Prof. Dr. med.

    Universitätsspital Zürich

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2018

First Posted

January 16, 2019

Study Start

August 26, 2010

Primary Completion

May 23, 2013

Study Completion

May 23, 2013

Last Updated

January 16, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share