Status:
COMPLETED
The Effects of HIV Protease Inhibitors in Severe Sepsis
Lead Sponsor:
Mayo Clinic
Conditions:
Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Sepsis is the leading cause of death in critically ill patients in the United States. It develops in approximately 750,000 Americans annually, and more than 210,000 of them die. Despite improvements i...
Detailed Description
Our hypothesis is that protease inhibitor therapy will prevent apoptosis associated with sepsis, and this will be manifested as improved clinical outcome, as assessed by 28-day mortality, APACHE II an...
Eligibility Criteria
Inclusion
- Infection criteria:known or suspected infection, as evidenced by one or more of the following: WBC in normally sterile body fluid, radiographic evidence of pneumonia, a syndrome associated with a high risk of infection.
- Modified SIRS criteria: must meet three or more of the following four criteria: a temperature higher than 38C or lower than 36C, heart rate of more than 90 beats/minute, respiratory rate of more than 20 breaths/minute (or on a mechanical ventilator), WBC more than 12,000/mm(3) or less than 4,000/mm(3).
- Dysfunctional organs criteria:must meet one or more of the following five criteria:cardiovascular system dysfunction, kidney dysfunction, respiratory dysfunction, hematological dysfunction, unexplained metabolic acidosis.
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00346580
Start Date
June 1 2003
End Date
September 1 2005
Last Update
April 5 2011
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905