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

NCT ID: NCT00980915

Last Updated: 2021-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2020-12-31

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.

Conditions

Acute Lung Injury; Acute Respiratory Distress Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

At risk for Acute Lung Injury

Controls-High risk patients at risk of Acute Lung Injury(ALI) but do not develop ALI

Cases-High risk patients that do develop Acute Lung Injury

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Ognjen Gajic

Ognjen Gajic, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ognjen Gajic, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

LIPSSTUDY

Identifier Type: -

Identifier Source: secondary_id

08-003560

Identifier Type: -

Identifier Source: org_study_id