Effects of Endotoxin in Normal Human Volunteers

Launched by NATIONAL INSTITUTES OF HEALTH CLINICAL CENTER (CC) · Nov 3, 1999

Keywords

ClinConnect Summary

Endotoxin is a unique molecule because it represents an important probe for investigating the humoral and cellular basis of septic shock. Endotoxin administration to humans provides an opportunity to evaluate the earliest responses that are activated after exposure to an important bacterial component. Many alterations in organ function and circulating mediators can be evaluated in this model. These changes are qualitatively similar to changes that occur during sepsis and septic shock. The applications of new technologies to this model are useful adjuncts to define mechanisms of acute inflam...

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • 1. 18 to 45 years of age, either male or female
• • 2. Employees or non-employees are eligible
• 3. Normal screening examination:
• • 1. history and physical examination, nonsmoker, no concurrent medications including aspirin or nonsteroidal anti-inflammatory drugs, no active medical problems;
• • 2. complete blood count with differential and platelet counts;
• • 3. serum chemistries including creatinine, blood urea nitrogen, glucose, liver enzymes and function tests, electrolytes, prothrombin time, partial thromboplastin time;
• • 4. urinalysis;
• • 5. female subjects must have negative urine pregnancy test within one week of participation;
• • 6. electrocardiogram;
• • 7. chest radiograph.
• • 4. If age is 40 to 45 years, normal submaximal stress test to screen for asymptomatic coronary artery disease.
• EXCLUSION CRITERIA:
• • Pregnancy.
• • Lactation.
• • History of recent clinically significant asthma.
• • Subjects who have an allergy to both sulfa- and penicillin-based drugs will not be eligible for the endotoxin instillation portion of the study.