Regional Lung Inflammation and Expansion in Mechanically Ventilated Patients - a PET/CT Study

NCT01806532 | Unknown

• 1 other identifier: 2008P000561
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to investigate acute respiratory distress syndrome (ARDS) and septic lung with positron emission tomography (PET) imaging and to examine the distribution of inflammation, as measured by neutrophil metabolic activity.

Conditions

Respiratory Failure

Keywords

computed tomography and positron emission tomography; respiration, artificial; respiratory distress syndrome, adult

Outcome Measures

Primary Outcomes (1)

• Regional 18F-FDG activity

  Each patient will undergo PET-CT scans and the regional 2-18F-fluoro-2-deoxy-D-glucose (18F-FDG) activity will be measured. This is a measure of regional neutrophil metabolic activity and is used to assess inflammation in the lung. The degree of inflammation will be related to the regional expansion of the lung, as measured by CT scan.

  Day of imaging.

Study Arms (1)

18F-FDG PET-CT

A total of 10 patients with acute respiratory distress syndrome (ARDS) will be imaged with 2-18F-fluoro-2-deoxy-D-glucose (18F-FDG) and PET-CT scan.

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

Adult intensive care patients requiring mechanical ventilation.

You may qualify if:

• Group 1
• Mechanically ventilated patients scheduled to undergo a CT scanning for their routine clinical care
• More than 24 hours of mechanical ventilation
• Less than 15 days of mechanical ventilation if patient presents ALI/ARDS (in order to exclude the late, fibrotic, stage of ARDS)
• Group 2
• Mechanically ventilated patients with a diagnosis of sepsis
• Less than 96 hours of mechanical ventilation

You may not qualify if:

• Age less than 18 years
• Hemodynamic instability, defined as: systolic blood pressure (SBP) \< 90 mmHg that is not adequately stabilized by vasopressors or inotropic agents. For these purposes, SBP will not be considered "adequately stabilized" if the dose of the vasopressor/inotrope has not been stable for at least one hour
• Hypoxemia, defined as: PaO2 \< 70 mmHg on an inspired oxygen fraction (FiO2) greater than or equal to 0.9; FiO2 greater than or equal to 0.8 at baseline
• Hemodynamic and/or respiratory instability (as defined, respectively, in 2 and 3), that develop when the patient is mobilized during routine nursing care such as repositioning/washing the patient or changing their bed linens
• Hemodynamic and/or respiratory instability (as defined, respectively, in 2 and 3), that develop when a 15-25 second respiratory pause is introduced as per the study protocol. This will be tested by inducing such a pause prior to transporting the patient
• Patients must be deemed by the treating clinical staff to be able to tolerate leaving the ICU for 90 minutes (40-60 minute imaging time + 30 minute safety margin). Treating MD, RT, and RN must all agree that the patient is stable for transport
• Any acute or chronic condition which, in the opinion of the investigator, might confound the imaging measurements (such as, but not limited to, severe bronchospasm, pulmonary infection, and lung tumor)
• "Air leaks" requiring tube thoracostomy (e.g., pneumothorax, bronchopleural fistula)
• Pregnancy (since this is a study which would expose a fetus to radiation risk)
• Patients who have neither an arterial nor a central venous line at the time of the enrollement

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be drawn and plasma stored for future potential biomarker studies.

MeSH Terms

Conditions

Respiratory Insufficiency; Respiratory Aspiration; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases

Central Study Contacts

Marcos Vidal Melo, MD, PhD

CONTACT

617-726-8980; VidalMelo.Marcos@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Harvard University

Study Record Dates

• First Submitted: March 5, 2013
• First Posted: March 7, 2013
• Study Start: January 1, 2008
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2019
• Last Updated: March 30, 2017

Record last verified: 2017-03

Locations

US (1)