Acute Lung InjuryLIPSNCT00980915
Timing and Intensity of the Exposures and Attributable Burden of Acute Lung Injury
An observational study of Acute Lung Injury and Acute Respiratory Distress Syndrome, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lung Injury, Acute Respiratory Distress Syndrome
- How many people
- 6,600 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Olmsted County residents more than 18 years of age who were admitted to the two Mayo Clinic Rochester hospitals.
Who may be able to join
- All Olmsted County residents more than 18 years of age who were admitted to the two Mayo Clinic Rochester hospitals
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Keywords
- Acute Lung Injury, Acute Respiratory Distress Syndrome, Respiratory Distress, pneumonia, sepsis, aspiration, pancreatitis
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome, Dyspnea, Pneumonia, Sepsis, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Development of ALI
Measured: During the hospital stay (before discharge and maximum of 30 days)
Secondary outcomes (1)
Quality adjusted survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ognjen Gajic, Mayo Clinic
- Investigators
- Ognjen Gajic, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980915
- Sponsor's protocol ID
- 08-003560
- Other IDs
- LIPSSTUDY
- Acronym
- LIPS
- Status last verified
- Feb 2021
- First submitted
- 30 Apr 2009
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00980915
- Acronym / sponsor ID
- LIPS / 08-003560
- Keywords
- Acute Lung Injury, Acute Respiratory Distress Syndrome, Respiratory Distress, pneumonia, sepsis, aspiration, pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,600 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 21 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Olmsted County residents more than 18 years of age who were admitted to the two Mayo Clinic Rochester hospitals.
Key inclusion criteria (1 listed)
- All Olmsted County residents more than 18 years of age who were admitted to the two Mayo Clinic Rochester hospitals
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of ALI
Time frame: During the hospital stay (before discharge and maximum of 30 days)
1 secondary outcome
Quality adjusted survival
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ognjen Gajic, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lung Injury and Acute Respiratory Distress Syndrome, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of ALI (time frame: During the hospital stay (before discharge and maximum of 30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.