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Clinical Trials/NCT03308214
NCT03308214
Completed
Not Applicable

The Analysis of Factors Influencing the Apparent Volume of Distribution of Imipenem in Septic Shock Patients

Southeast University, China1 site in 1 country25 target enrollmentMarch 18, 2018
ConditionsSeptic Shock
InterventionsImipenem

Overview

Phase
Not Applicable
Intervention
Imipenem
Conditions
Septic Shock
Sponsor
Southeast University, China
Enrollment
25
Locations
1
Primary Endpoint
the apparent volume of distribution
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The study measures the plasma concentrations of imipenem in septic shock patients and non-septic shock patients and observes hypoalbuminemia and the impact of the severity of critical illness on Vd

Detailed Description

Severe sepsis and septic shock are major causes of mortality in intensive care unit(ICU) patients.Correct and adequate antibiotic coverage is essential but can be complex as a result of fluid resuscitation, hypoalbuminemia, organ dysfunction, the application of extracorporeal support modalities and the impact of critical illness on pharmacokinetics(PK).Such changes will significantly distort the normal anti-biotic PK profile, resulting in drug exposure that is markedly different from the 'healthy volunteer.'The apparent volume of distribution is one of important PK parameters.Vd determines the loading dose. This review article considers these issues in detail, summarizing the key changes in antibiotic Vd in the critically ill, and providing general suggestions how to optimization of antibiotic dosing to manage Vd challenges.50 patients who receives the theapy of imipenem are included in this study.Whether hypoalbuminemia, organ dysfunction, the application of extracorporeal support modalities and the impact of critical illness on Vd will be evaluted.

Registry
clinicaltrials.gov
Start Date
March 18, 2018
End Date
December 28, 2018
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Southeast University, China
Responsible Party
Principal Investigator
Principal Investigator

Songqiao Liu

MD. PHD

Southeast University, China

Eligibility Criteria

Inclusion Criteria

  • age between 18 years old and 80 years old;
  • Admitted to the ICU;
  • Patients diagnosed as septic shock requiring the therapy of imipenem(0.5g q6h or 1.0g q8h;

Exclusion Criteria

  • Patient participated in another interventional trial before enrollment
  • Allergy, hypersensitivity or a serious reaction to imipenem;
  • patients with ECMO and(or)CRRT.

Arms & Interventions

septic shock

Patients with septic shock treat with Imipenem

Intervention: Imipenem

non-septic shock

Patients with infection but not septic shock treat with Imipenem

Intervention: Imipenem

Outcomes

Primary Outcomes

the apparent volume of distribution

Time Frame: Day1, Day 3, Day 7

The imipenem plasma concentrations are measured at different time to calculate Vd

Study Sites (1)

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