Timing and Intensity of the Exposures and Attributable Burden of Acute Lung Injury

Completed

• Conditions: Acute Lung Injury; Acute Respiratory Distress Syndrome

• Registration Number: NCT00980915
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-04-30
• Study First Submitted QC: 2009-09-18
• Study First Posted: 2009-09-21
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6600

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of ALI	During the hospital stay (before discharge and maximum of 30 days)

Secondary Outcome Measures

Name	Time	Method
Quality adjusted survival	6 months

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States