Timing and Intensity of the Exposures and Attributable Burden of Acute Lung Injury (LIPS)

Identifying Patients at Risk of Developing Acute Lung Injury at the Time of Hospital Admission:Toward the Prevention of Acute Lung Injury (ALI)

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome; Acute Lung Injury

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 Type: Observational
• Enrollment (Anticipated): 6600

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Development of ALI	During the hospital stay (before discharge and maximum of 30 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality adjusted survival	6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Ognjen Gajic, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: April 30, 2009
• First Submitted That Met QC Criteria: September 18, 2009
• First Posted (Estimate): September 21, 2009

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: pneumonia; sepsis; Acute Respiratory Distress Syndrome; pancreatitis; aspiration; Acute Lung Injury; Respiratory Distress
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Thoracic Injuries; Wounds and Injuries; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: 08-003560; LIPSSTUDY