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OpenTrials
Completed

NCT Number: NCT00980915

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Development of ALI

    Time frame: During the hospital stay (before discharge and maximum of 30 days)

Secondary outcomes

  1. Quality adjusted survival

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: LIPS

Important dates

Study start
2008
Primary completion
2020
Study completion
2020
First posted
Sep 21, 2009
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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