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

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ClinicalTrials.gov Identifier: NCT00980915
Recruitment Status : Active, not recruiting
First Posted : September 21, 2009
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Acute Lung Injury Acute Respiratory Distress Syndrome

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 Design

Study Type : Observational
Estimated Enrollment : 6600 participants
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)
Study Start Date : December 2008
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Groups and Cohorts

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



Outcome Measures

Primary Outcome Measures :
  1. Development of ALI [ Time Frame: During the hospital stay (before discharge and maximum of 30 days) ]

Secondary Outcome Measures :
  1. Quality adjusted survival [ Time Frame: 6 months ]

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00980915


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Ognjen Gajic, M.D. Mayo Clinic
More Information

Responsible Party: Ognjen Gajic, Ognjen Gajic, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00980915     History of Changes
Other Study ID Numbers: 08-003560
LIPSSTUDY
First Posted: September 21, 2009    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

Keywords provided by Ognjen Gajic, Mayo Clinic:
Acute Lung Injury
Acute Respiratory Distress Syndrome
Respiratory Distress
pneumonia
sepsis
aspiration
pancreatitis

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Wounds and Injuries
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries