The Analysis of Factors Influencing the Vd of Imipenem in Septic Shock Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03308214

Enrollment

Registered

2017-10-12

Start date

2018-03-18

Completion date

2018-12-28

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Keywords

septic shock; imipenem; VD ;pharmacokinetics

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.

Interventions

DRUGImipenem

Imipenem 1.0 q 8h

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Inclusion criteria

1. age between 18 years old and 80 years old; 2. Admitted to the ICU; 3. Patients diagnosed as septic shock requiring the therapy of imipenem(0.5g q6h or 1.0g q8h;

Exclusion criteria

1. Patient participated in another interventional trial before enrollment 2. Allergy, hypersensitivity or a serious reaction to imipenem; 3. Pregnancy. 4. patients with ECMO and(or)CRRT. 5. tumors.

Design outcomes

Primary

Measure	Time frame	Description
the apparent volume of distribution	Day1, Day 3, Day 7	The imipenem plasma concentrations are measured at different time to calculate Vd

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026