Status:
COMPLETED
Population Pharmacokinetics and Monte Carlo Dosing Simulations of Meropenem During the Early Phase of Severe Sepsis and Septic Shock in Critically Ill Patients in Intensive Care Units
Lead Sponsor:
Sutep Jaruratanasirikul
Collaborating Sponsors:
Prince of Songkla University
Conditions:
Initial Phase of Severe Sepsis and Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a prospective, noncomparative study to assess the pharmacodynamics of meropenem during early phase of severe sepsis and septic shock in critically ill patients in an intensive care unit. Clin...
Detailed Description
Introduction: Severe sepsis/septic shock are one of the most important reasons for admission the critically-ill patient to Intensive Care Units (ICU) and remaining a major causes of high mortality. E...
Eligibility Criteria
Inclusion
- Patient age \> 18 years
- Patients who diagnosed as severe sepsis or septic shock, either at admission or during the ICU stay. Sepsis is the systemic response to infections defined by two or more of the following conditions: body temperature of \>38 oC or \<36 oC; heart rate of \> 90 beats per min; respiratory rate of \>20 breaths per min or a PaCO2 of \<32 mmHg; or leucocyte count \>12,000 cell/mm3, \<4,000 cell/mm3 or 10% immature (band) forms. Severe sepsis is defined by sepsis associated with organ dysfunction, hypoperfusion, or hypotension (systolic arterial pressure \<90 mmHg, mean arterial pressure \<70 mmHg or a reduction of ≥40 mmHg from baseline). Septic shock is defined by severe sepsis associated with hypotension despite adequate fluid resuscitation
Exclusion
- Patients who are pregnant.
- Patients who have documented hypersensitivity to carbapenems.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02213796
Start Date
January 1 2013
End Date
December 1 2013
Last Update
August 11 2014
Active Locations (1)
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1
Prince of Songkla University
Hat Yai, Changwat Songkhla, Thailand, 90110