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

NCT00980915 | Completed DMC

• 2 other identifiers: 08-003560LIPSSTUDY
• Study Type: observational
• Target: 6,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lung Injury; Acute Respiratory Distress Syndrome

Keywords

Acute Lung Injury; Acute Respiratory Distress Syndrome; Respiratory Distress; pneumonia; sepsis; aspiration; pancreatitis

Outcome Measures

Primary Outcomes (1)

• Development of ALI

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

Secondary Outcomes (1)

• Quality adjusted survival

  6 months

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All Olmsted County residents more than 18 years of age who were admitted to the two Mayo Clinic Rochester hospitals

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

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.

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome; Dyspnea; Pneumonia; Sepsis; Pancreatitis

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pancreatic Diseases; Digestive System Diseases

Study Officials

• Ognjen Gajic, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ognjen Gajic, M.D.

Study Record Dates

• First Submitted: April 30, 2009
• First Posted: September 21, 2009
• Study Start: December 1, 2008
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 5, 2021

Record last verified: 2021-02

Locations

US (1)