- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00889772
Lung Injury Prediction Study (USCTG-LIPS1)
September 22, 2015 updated by: Ognjen Gajic, Mayo Clinic
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)
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).
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Minnesota
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Rochester, Minnesota, United States, 55902
- Mayo Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Acute Lung Injury or Acute Respiratory Distress Syndrome
Time Frame: during hospital stay
|
during hospital stay
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Survival
Time Frame: in hospital
|
in hospital
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ognjen Gajic, M.D., Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Chang SY, Dabbagh O, Gajic O, Patrawalla A, Elie MC, Talmor DS, Malhotra A, Adesanya A, Anderson HL 3rd, Blum JM, Park PK, Gong MN; United States Critical Illness and Injury Trials Group: Lung Injury Prevention Study Investigators (USCIITG-LIPS). Contemporary ventilator management in patients with and at risk of ALI/ARDS. Respir Care. 2013 Apr;58(4):578-88. doi: 10.4187/respcare.01755.
- Gajic O, Dabbagh O, Park PK, Adesanya A, Chang SY, Hou P, Anderson H 3rd, Hoth JJ, Mikkelsen ME, Gentile NT, Gong MN, Talmor D, Bajwa E, Watkins TR, Festic E, Yilmaz M, Iscimen R, Kaufman DA, Esper AM, Sadikot R, Douglas I, Sevransky J, Malinchoc M; U.S. Critical Illness and Injury Trials Group: Lung Injury Prevention Study Investigators (USCIITG-LIPS). Early identification of patients at risk of acute lung injury: evaluation of lung injury prediction score in a multicenter cohort study. Am J Respir Crit Care Med. 2011 Feb 15;183(4):462-70. doi: 10.1164/rccm.201004-0549OC. Epub 2010 Aug 27.
- Trillo-Alvarez C, Cartin-Ceba R, Kor DJ, Kojicic M, Kashyap R, Thakur S, Thakur L, Herasevich V, Malinchoc M, Gajic O. Acute lung injury prediction score: derivation and validation in a population-based sample. Eur Respir J. 2011 Mar;37(3):604-9. doi: 10.1183/09031936.00036810. Epub 2010 Jun 18.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
April 27, 2009
First Submitted That Met QC Criteria
April 28, 2009
First Posted (Estimate)
April 29, 2009
Study Record Updates
Last Update Posted (Estimate)
September 24, 2015
Last Update Submitted That Met QC Criteria
September 22, 2015
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-008726
- USCIITG-LIPS1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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