Clinical trial NCT00889772: Lung Injury Prediction 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress
Acute Lung Injury
Keywords: Respiratory distress, adult
risk
emergency room
high risk surgery
sepsis
trauma
aspiration
pneumonia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
name: Temple University
name: Johns Hopkins University
name: University of Medicine and Dentistry of New Jersey
name: University of Colorado, Denver
name: University of Pennsylvania
name: Brigham and Women's Hospital
name: Boston University
name: University of Michigan
name: University of Texas Southwestern Medical Center
name: Providence Health & Services
name: University of Illinois at Chicago
name: Wake Forest University
name: Bridgeport Hospital
name: Massachusetts General Hospital
name: Beth Israel Deaconess Medical Center
name: Wright State University
name: University of Missouri-Columbia
name: Uludag University
name: Akdeniz University
First posted: 2009-04-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
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

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).


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

Primary outcomes:
measure: Acute Lung Injury or Acute Respiratory Distress Syndrome
timeFrame: during hospital stay
Secondary outcomes:
measure: Survival
timeFrame: in hospital
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ognjen Gajic, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.