Lung Injury Prediction Study - Full Text View

Lung Injury Prediction Study (USCTG-LIPS1)

This study is currently recruiting participants.

Verified by Mayo Clinic, April 2009

First Received: April 27, 2009 Last Updated: April 28, 2009 History of Changes

Sponsors and Collaborators:	Mayo Clinic Mount Sinai School of Medicine, New York, NY Temple University Johns Hopkins University University of Medicine and Dentistry New Jersey University of Colorado at Denver and Health Sciences Center University of Pennsylvania Brigham and Women's Hospital Boston University University of Michigan University of Texas Southwestern Medical Center Providence Regional Medical Center University of Illinois Wake Forest University Bridgeport Hospital Massachusetts General Hospital Beth Israel Deaconess Medical Center Wright State University University of Missouri-Columbia Uludag University Akdeniz University
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00889772

Purpose

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).

Condition
Respiratory Distress Acute Lung Injury

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort
Official Title:	Identifying Patients at Risk of Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) at the Time of Hospital Admission: External Validation of a Lung Injury Prediction Score (LIPS)

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Acute Lung Injury or Acute Respiratory Distress Syndrome [ Time Frame: during hospital stay ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Survival [ Time Frame: in hospital ] [ Designated as safety issue: No ]

Estimated Enrollment:	6000
Study Start Date:	March 2009
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889772

Contacts

Contact: Ognjen Gajic, M.D.

gajic.ognjen@mayo.edu

Locations

United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55902

Sponsors and Collaborators

Mayo Clinic

Mount Sinai School of Medicine, New York, NY

Temple University

Johns Hopkins University

University of Medicine and Dentistry New Jersey

University of Colorado at Denver and Health Sciences Center

University of Pennsylvania

Brigham and Women's Hospital

Boston University

University of Michigan

University of Texas Southwestern Medical Center

Providence Regional Medical Center

University of Illinois

Wake Forest University

Bridgeport Hospital

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Wright State University

University of Missouri-Columbia

Uludag University

Akdeniz University

Investigators

Principal Investigator:

Ognjen Gajic, M.D.

Mayo Clinic

More Information

No publications provided

Responsible Party:	Mayo Clinic ( Ognjen Gajic, M.D. )
Study ID Numbers:	08-008726, USCIITG-LIPS1
Study First Received:	April 27, 2009
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00889772 History of Changes
Health Authority:	United States: Institutional Review Board; Turkey: Ministry of Health

Keywords provided by Mayo Clinic:

Respiratory distress, adult
risk
emergency room
high risk surgery

sepsis
trauma
aspiration
pneumonia

Study placed in the following topic categories:

Sepsis
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Adult

Acute Respiratory Distress Syndrome
Wounds and Injuries
Emergencies
Pneumonia

Additional relevant MeSH terms:

Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Adult

ClinicalTrials.gov processed this record on May 07, 2009