Timing and Intensity of the Exposures and Attributable Burden of Acute Lung Injury (LIPS)
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Purpose
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.
| Condition |
|---|
|
Acute Lung Injury Acute Respiratory Distress Syndrome |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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) |
- Development of ALI [ Time Frame: During the hospital stay (before discharge and maximum of 30 days) ] [ Designated as safety issue: No ]
- Quality adjusted survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
We will collect time sensitive peripheral blood samples for collaborative genome-wide association, gene expression, cytokines and proteonomic studies. Blood samples of the enrolled patients will be collected as baseline, after 24, 48 hours and at the time of development of ARDS.
| Estimated Enrollment: | 1800 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Olmsted County residents more than 18 years of age who were admitted to the two Mayo Clinic Rochester hospitals.
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
Contacts and Locations| Contact: Ognjen Gajic, M.D. | 507-255-6051 | gajic.ognjen@mayo.edu |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Ognjen Gajic, M.D. 507-255-6051 gajic.ognjen@mayo.edu | |
| Contact: Sweta Thakur, M.B.B.S. 507-255-4407 thakur.sweta@mayo.edu | |
| Principal Investigator: Ognjen Gajic, M.D. | |
| Principal Investigator: | Ognjen Gajic, M.D. | Mayo Clinic |
More Information
No publications provided
| Responsible Party: | Ognjen Gajic, Ognjen Gajic, M.D., Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00980915 History of Changes |
| Other Study ID Numbers: | 08-003560, LIPSSTUDY |
| Study First Received: | April 30, 2009 |
| Last Updated: | November 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
Acute Lung Injury Acute Respiratory Distress Syndrome Respiratory Distress pneumonia |
sepsis aspiration pancreatitis |
Additional relevant MeSH terms:
|
Thoracic Injuries Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury Lung Diseases |
Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013