Status:
COMPLETED
Carbon Monoxide to Prevent Lung Inflammation
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Respiratory Distress Syndrome, Adult
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
This study will examine in healthy volunteers how breathing carbon monoxide (CO) affects lung inflammation. Severe lung inflammation sometimes develops in patients with pneumonia or patients who devel...
Detailed Description
Acute respiratory distress syndrome (ARDS) is a major cause of morbidity and mortality. Of the many potential predisposing factors, sepsis and pneumonia represent the two main causes of ARDS. In spite...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- All volunteer subjects, employees and non-employees, must 18 to 40 years of age and must be able to provide informed, written consent for participation in this study. We will not directly advertise the study to employees to avoid the potential for coercion. Eligibility in the study is determined prior to enrollment on the basis of the following inclusion and exclusion criteria.
- Normal screening examination including:
- medical history and physical examination, nonsmoker, no concurrent medications including aspirin or nonsteroidal anti-inflammatory drugs, no active medical problems
- complete blood count with differential and platelet counts
- serum chemistries including creatinine, blood urea nitrogen, glucose, liver enzymes and function tests, electrolytes, prothrombin time, partial thromboplastin time, carboxyhemoglobin measured by venous co-oxymetry.
- urinalysis
- female subjects must have negative urine pregnancy test within one week of participation (this will be repeated immediately prior to beginning the screening procedures due to radiation exposure from the chest x-ray)
- electrocardiogram
- chest radiograph
- Sexually active females not using contraceptive methods will be instructed to abstain from sexual activity or use barrier contraception methods from the time of last negative pregnancy test to 24 hours after completion of the study.
- EXCLUSION CRITERIA:
- active tobacco use
- baseline caroxyhemoglobin greater than 2%
- pregnancy
- lactation
- medical history of recent clinically significant asthma allergy to both sulfa- and penicillin-based drugs
- Allergy to both sulfa- and penicillin-based drugs.
Exclusion
Key Trial Info
Start Date :
October 13 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2010
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00094406
Start Date
October 13 2004
End Date
March 11 2010
Last Update
December 17 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892