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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02213796
• Date of registration: 08/08/2014
• Prospective Registration: No
• Primary sponsor: Sutep Jaruratanasirikul
• Public title: 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
• Scientific title: 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
• Date of first enrolment: January 2013
• Target sample size: 9
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02213796
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
• Phase: Phase 4

Countries of recruitment

Thailand

Contacts

• Name: Sutep Jaruratanasirikul, MD
• Affiliation: Prince of Songkla University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patient age > 18 years

2. 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 Criteria:

1. Patients who are pregnant.

2. Patients who have documented hypersensitivity to carbapenems.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Initial Phase of Severe Sepsis and Septic Shock

Intervention(s)

Drug: Meropenem

Primary Outcome(s)

Concentration of meropenem in plasma [Time Frame: 16 hour after first dose]

Secondary ID(s)

MEROICU14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Prince of Songkla University