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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

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ClinicalTrials.gov Identifier: NCT02213796
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : August 11, 2014
Sponsor:
Collaborator:
Prince of Songkla University
Information provided by (Responsible Party):
Sutep Jaruratanasirikul, Prince of Songkla University

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.

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock
Drug Information available for: Meropenem

Arm Intervention/treatment
1h infusion of 1 g meropenem Drug: Meropenem



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Thailand
Prince of Songkla University
Hat Yai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Sutep Jaruratanasirikul
Prince of Songkla University
Investigators
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Principal Investigator: Sutep Jaruratanasirikul, MD Prince of Songkla University

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Responsible Party: Sutep Jaruratanasirikul, Principal investigator, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT02213796     History of Changes
Other Study ID Numbers: MEROICU14
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: August 11, 2014
Last Verified: August 2014
Keywords provided by Sutep Jaruratanasirikul, Prince of Songkla University:
meropenem, early phase, severe sepsis and septic shock, critically ill, population pharmacokinetics
Additional relevant MeSH terms:
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Sepsis
Toxemia
Shock, Septic
Shock
Critical Illness
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Disease Attributes
Meropenem
Anti-Bacterial Agents
Anti-Infective Agents