Study of the Function of Cells Involved in Inflammation in the Lungs of Those With Acute Lung Injury and Sepsis

NCT01725061 | Completed

• 1 other identifier: IRB00014152
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Acute lung injury (ALI) is an often deadly form of respiratory failure caused by inflammation. The widespread injury to the lungs involves a build-up of fluid in the lungs that results in damage to the lungs and a decreased ability of the lungs to function properly. There is currently no specific treatment for ALI; and of the 200,000 cases reported in the US yearly, about 40% will die. Some patients may have other conditions that could change the risk of developing ALI. For example, it has been reported that patients who have septic shock have a lower chance of developing ALI if they also have diabetes mellitus (diabetes). Septic shock is a type of infection that causes overwhelming inflammation to occur throughout the body; it increases the chances that a person will develop ALI. The reason diabetics are less likely to develop ALI is unclear and deserves further investigation. The investigators believe that it may be explained by differences in the way certain cells that are involved in inflammation function in the lungs. The investigators plan on looking at the relationship between the wide-spread inflammation that occurs within the bodies of diabetic and non-diabetic patients with an increased chance of developing ALI \[sepsis\]. To study this relationship, we will identify patients who fit the requirements of the study. The investigators will obtain blood samples and lung washings from these patients. The lung washings will be obtained by injecting clean salt water into the lungs through a tube and then pulling the water back out. When the sterile water is removed, some cells from the lungs also are removed and they can then be used for further lab studies. Determining how diabetes may change a patient's chance of developing ALI may uncover useful information that may help prevent or treat ALI in all patients at risk.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Development of acute lung injury

  within 7 days

Secondary Outcomes (1)

• mortality

  28 day

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

Patients in the ICU with severe sepsis ot septic shock that are on mechanical ventilation.

You may qualify if:

• Patients within the first 72 hours of development of severe sepsis or septic shock

You may not qualify if:

• No informed consent
• Pregnancy
• Expected survival ≤ 72 hours
• Not mechanically ventilated
• Age \< 18 years

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30308, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and bronchoalveolar lavage fluid

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Annette Esper, MD, MSc

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 12, 2012
• Study Start: December 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

US (1)