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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

NCT02213796 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2014-08-11

No results posted yet for this study

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.

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)

Conditions

  • Initial Phase of Severe Sepsis and Septic Shock

Interventions

DRUG

Meropenem

Sponsors & Collaborators

  • Prince of Songkla University

    collaborator OTHER

  • Sutep Jaruratanasirikul

    lead OTHER

Principal Investigators

  • Sutep Jaruratanasirikul, MD · Prince of Songkla University

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02213796 on ClinicalTrials.gov