Respiratory DistressUSCTG-LIPS1NCT00889772
Lung Injury Prediction Study
An observational study of Respiratory Distress and Acute Lung Injury, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress, Acute Lung Injury
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Feb 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- Hospitalized adult patients with one of the known risk factors for acute lung injury at the time of hospital admission
Who cannot join
- ALI/ARDS already present at the time of hospital admission, denied use of medical records for research, children, hospital readmission, transfer from another hospital
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
- Conditions
- Respiratory Distress, Acute Lung Injury
- Keywords
- Respiratory distress, adult, risk, emergency room, high risk surgery, sepsis, trauma, aspiration, pneumonia
- Medical subject headings
- Dyspnea, Acute Lung Injury, Emergencies, Sepsis, Wounds and Injuries, Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Lung Injury or Acute Respiratory Distress Syndrome
Measured: during hospital stay
Secondary outcomes (1)
Survival
Measured: in hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Respiratory DistressStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- 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 Health & Services, 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
- Responsible party
- Principal investigator, Ognjen Gajic, Mayo Clinic
- Investigators
- Ognjen Gajic, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889772
- Sponsor's protocol ID
- 08-008726
- Other IDs
- USCIITG-LIPS1
- Acronym
- USCTG-LIPS1
- Status last verified
- Jun 2012
- First submitted
- 27 Apr 2009
- Last updated
- 24 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 31735660Chang 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.
PubMed 22906363Gajic 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.
PubMed 20802164Trillo-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.
PubMed 20562130
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00889772
- Acronym / sponsor ID
- USCTG-LIPS1 / 08-008726
- Conditions
- Respiratory Distress, Acute Lung Injury
- Keywords
- Respiratory distress, adult, risk, emergency room, high risk surgery, sepsis, trauma, aspiration, pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- 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 Health & Services, 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
- Study start
- Mar 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 29 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (1 listed)
- Hospitalized adult patients with one of the known risk factors for acute lung injury at the time of hospital admission
Key exclusion criteria (1 listed)
- ALI/ARDS already present at the time of hospital admission, denied use of medical records for research, children, hospital readmission, transfer from another hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute Lung Injury or Acute Respiratory Distress Syndrome
Time frame: during hospital stay
1 secondary outcome
Survival
Time frame: in hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2015.
- Derived from this study: PubMed 31735660George 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.
- Derived from this study: PubMed 22906363Chang 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.
- Derived from this study: PubMed 20802164Gajic 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.
- Derived from this study: PubMed 20562130Trillo-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ognjen Gajic, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress and Acute Lung Injury, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Lung Injury or Acute Respiratory Distress Syndrome (time frame: during hospital stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00889772, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2015.