Lung Injury Prediction Study | NCT00889772

Studies
Lung Injury Prediction Study

NCT00889772

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Sep 24, 2015Estimated

Enrollment

300Actual

Phase

Not provided

Conditions

Respiratory Distress
Acute Lung Injury

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
USCIITG-LIPS1

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

Apr 27, 2009

First Submission Date that Met QC Criteria

Apr 28, 2009

First Posted Date

Apr 29, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2015

Last Update Posted Date

Sep 24, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ognjen Gajic, Consultant - Critical Care, Mayo ClinicPrincipal Investigator

Lead Sponsor

Mayo ClinicOTHER

Collaborators

Name	Class
Icahn School of Medicine at Mount Sinai	OTHER
Temple University	OTHER
Johns Hopkins University	OTHER
University of Medicine and Dentistry of New Jersey

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to externally validate the acute lung injury/acute respiratory distress syndrome (ALI/ARDS) prediction model (Lung Injury Prediction Score - LIPS) in a multicenter sample of patients at risk presented to the acute care hospitals: United States Critical Illness and Injury Trials Group (USCIITG).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acute Lung Injury or Acute Respiratory Distress Syndrome		during hospital stay

Secondary Outcomes

Measure	Description	Time Frame
Survival		in hospital

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hospitalized adult patients with one of the known risk factors for acute lung injury at the time of hospital admission

Exclusion Criteria:

ALI/ARDS already present at the time of hospital admission, denied use of medical records for research, children, hospital readmission, transfer from another hospital

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Consecutive patients >18 years of age with one or more predisposing conditions for ALI/ARDS (pneumonia, sepsis, shock, pancreatitis, aspiration, high risk trauma and high risk surgery) at the time of hospital admission

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ognjen Gajic, M.D.	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55902	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31735660	Derived	George N, Elie-Turenne MC, Seethala RR, Baslanti TO, Bozorgmehri S, Mark K, Meurer D, Bihorac A, Aisiku IP, Hou PC; U.S. Critical Illness and Injury Trials Group-Lung Injury Prevention Study Investigators. External Validation of the qSOFA Score in Emergency Department Patients With Pneumonia. J Emerg Med. 2019 Dec;57(6):755-764. doi: 10.1016/j.jemermed.2019.08.043. Epub 2019 Nov 15.
22906363

ID	Term
D004417	Dyspnea
D055371	Acute Lung Injury
D004630	Emergencies
D018805	Sepsis
D014947	Wounds and Injuries
D011014	Pneumonia

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms