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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02213796|
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : August 11, 2014
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.
Clinical and laboratory data such as age,sex, body weight, electrolyte, vital signs, APACHE II score, SOFA score, BUN, Cr and blood culture will be collected.
Twelve patients will be enrolled in this study. Meropenem pharmacokinetic will be carried out during the first and second dose after 1g meropenem administration. Blood samples (approximately 3 ml) will be obtained by direct venepuncture at the following time: 0, 0.25, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 8, 8.5, 9, 9.5, 10, 12, 14 and 16 h.
Meropenem assays will be performed by modified method of Ozkan et al. (Biomed. Chromatogr., 2001).
The pharmacokinetics of meropenem will be modelled from concentration-time profile using compartmental model. Monte Carlo simulation to assess PK/PD index as 40% and 100% T>MIC will be conducted and the results will be reported as % PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response)
|Condition or disease||Intervention/treatment||Phase|
|Initial Phase of Severe Sepsis and Septic Shock||Drug: Meropenem||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
|1h infusion of 1 g meropenem||
- Concentration of meropenem in plasma [ Time Frame: 16 hour after first dose ]Concentration of meropenem inplasma will be simulated in Monte Carli simulation to assess PK/PD index as 40% and 100 T>MIC and will be reported as %PTA.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213796
|Prince of Songkla University|
|Hat Yai, Songkhla, Thailand, 90110|
|Principal Investigator:||Sutep Jaruratanasirikul, MD||Prince of Songkla University|