Status:
COMPLETED
PET Imaging in Patients at Risk for Acute Lung Injury
Lead Sponsor:
Washington University School of Medicine
Conditions:
Acute Lung Injury
Early Pulmonary Neutrophilic Inflammation
Eligibility:
All Genders
18+ years
Brief Summary
Despite decades of research, the mortality in acute lung injury remains very high and treatment options are very limited. Given these facts, the best treatment modality may be in prevention of this le...
Eligibility Criteria
Inclusion
- Adults patients (age ≥ 18) presenting to the SICU after ≥ 5 hours of mechanical ventilation in the OR or ED, without clinical evidence of ALI, and LIPS \> 4 or \< 4.
- Able to be positioned supine within the PET/CT scanner for \~1.25 hours
- Has legally authorized representative (LAR) available and willing to give informed consent, or is able to give informed consent prior to initiation of mechanical ventilation
- BMI \< 35
Exclusion
- Established ALI by accepted clinical criteria.
- Organ transplant recipient
- Treatment with immunosuppressive/immune-modulating medications
- Current corticosteroid treatment
- Chronic pulmonary or nonpulmonary inflammatory diseases
- Inability to safely travel out of the SICU (as established by regular safety screening criteria). Patient is placed in the supine position for a minimum of 30 minutes, and on mechanical ventilator settings that will be in place for the duration of the FDG-PET study. The patient is deemed unsafe for travel if oxygen requirement increases or any hemodynamic instability ensues (such as increasing vasopressor requirements).
- Glucose level \> 150 mg/dl at time of PET scan
- Pregnancy (confirmed by qualitative urine hCG pregnancy test)
- Lactation
- Presence of implanted electronic medical device
- Enrollment in another research study of an investigational drug
- Prior research-related radiation exposure within the past year such that participation in this study would result in exposures that exceed the limits as defined by the FDA RDRC regulations (21 CFR 361.1)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01486342
Start Date
October 1 2011
End Date
October 1 2012
Last Update
January 4 2013
Active Locations (1)
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1
Washington University in St. Louis School of Medicine
St Louis, Missouri, United States, 63110