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Lung Injury Prediction Study (USCTG-LIPS1)

This study has been completed.
Sponsor:
Collaborators:
Icahn School of Medicine at Mount Sinai
Temple University
Johns Hopkins University
University of Medicine and Dentistry of New Jersey
University of Colorado, Denver
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 at Chicago
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 (Responsible Party):
Ognjen Gajic, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00889772
First received: April 27, 2009
Last updated: September 22, 2015
Last verified: June 2012
  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

Study Type: Observational
Study Design: Observational Model: 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)

Resource links provided by NLM:


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 ]

Enrollment: 300
Study Start Date: March 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
Sponsors and Collaborators
Mayo Clinic
Icahn School of Medicine at Mount Sinai
Temple University
Johns Hopkins University
University of Medicine and Dentistry of New Jersey
University of Colorado, Denver
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 at Chicago
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ognjen Gajic, Consultant - Critical Care, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00889772     History of Changes
Other Study ID Numbers: 08-008726  USCIITG-LIPS1 
Study First Received: April 27, 2009
Last Updated: September 22, 2015
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

Additional relevant MeSH terms:
Wounds and Injuries
Respiratory Distress Syndrome, Adult
Lung Injury
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Thoracic Injuries

ClinicalTrials.gov processed this record on September 23, 2016