Clinical trial NCT00980915: Timing and Intensity of the Exposures and Attributable Burden of Acute Lung Injury
Official title: Identifying Patients at Risk of Developing Acute Lung Injury at the Time of Hospital Admission:Toward the Prevention of Acute Lung Injury (ALI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lung Injury
Acute Respiratory Distress Syndrome
Keywords: Acute Lung Injury
Acute Respiratory Distress Syndrome
Respiratory Distress
pneumonia
sepsis
aspiration
pancreatitis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-09-21
Enrollment: 6600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Olmsted County residents more than 18 years of age who were admitted to the two Mayo Clinic Rochester hospitals.

Brief summary: The purpose of the study is to identify the patients at high risk of developing Acute Lung Injury (ALI) at the time of hospital admission, and before intensive care unit admission.

Aim 1- To validate the prediction model (Lung Injury Prediction Score) in a population based sample of hospitalized patients.

Aim 2- To determine the significance of health-care related ALI risk modifiers in a population based sample.

Aim 3- To compare the short and long term outcomes between patients at high risk who do, and do not develop ALI.

Detailed description: Acute lung injury (ALI) is an example of a critical care syndrome with limited treatment options once the condition is fully established.Not surprisingly, many treatments targeting the mechanisms identified in preclinical studies have failed to improve patient outcomes.The most likely reason could be due to inadequate and delayed recognition of patients at risk and the subsequent development of the full blown syndrome.ALI/ARDS usually develops during the first hours of ICU admission, and often is the very reason for ICU admission.

Clinical prediction models have been extensively used in the clinical practice to identify patients at high risks who may benefit from specific interventions. However, no such tool exists to predict the development of ALI in patients at risk. We have recently developed an ALI prediction model (Lung Injury Prediction Score:LIPS)which incorporates demographic, environmental and clinical characteristics at the time of, and before, hospital admission. If validated, this model will serve to find the population of patients at high risk of ALI in whom future prevention trials will be conducted. By determining not only patients at high risk but also the attributable burden of ALI/ARDS in contemporary cohorts of patients at risk, our findings will facilitate the prioritization of preventive strategies and future clinical trials.

Eligibility criteria: Inclusion Criteria:

* All Olmsted County residents more than 18 years of age who were admitted to the two Mayo Clinic Rochester hospitals

Exclusion Criteria:

* Denied the use of medical records for research
* Acute lung injury or pulmonary edema already present at the time of hospital admission
* Admitted for comfort or hospice care only
* Children
* Hospital readmission
* Patients admitted for cardiac telemetry, coronary care unit, low risk elective surgeries, labor and delivery

Primary outcomes:
measure: Development of ALI
timeFrame: During the hospital stay (before discharge and maximum of 30 days)
Secondary outcomes:
measure: Quality adjusted survival
timeFrame: 6 months
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: