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

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

Study Overview

• Status: Completed
• Conditions: Septic Shock
• Intervention / Treatment: Drug: Imipenem

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.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital, Southeast University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

septic shock patients and non-septic shock patients with the therapy of imipenem in the ICU of Zhongda hospital

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
septic shock; Patients with septic shock treat with Imipenem	Drug: Imipenem; Imipenem 1.0 q 8h
non-septic shock; Patients with infection but not septic shock treat with Imipenem	Drug: Imipenem; Imipenem 1.0 q 8h

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Southeast University, China
• Investigators: Principal Investigator: Songqiao Liu, PHD, Study Investigator

Publications and helpful links

General Publications

• Huang Y, Yang J, Xie J, Liu L, Liu S, Guo F, Qiu H, Yang Y. Association Between Pathophysiology and Volume of Distribution Among Patients With Sepsis or Septic Shock Treated With Imipenem: A Prospective Cohort Study. J Infect Dis. 2020 Mar 16;221(Suppl 2):S272-S278. doi: 10.1093/infdis/jiz651.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 18, 2018
• Primary Completion (ACTUAL): December 28, 2018
• Study Completion (ACTUAL): December 28, 2018

Study Registration Dates

• First Submitted: September 25, 2017
• First Submitted That Met QC Criteria: October 8, 2017
• First Posted (ACTUAL): October 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 1, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: septic shock; imipenem; VD ;pharmacokinetics
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock; Anti-Infective Agents; Anti-Bacterial Agents; Imipenem
• Other Study ID Numbers: 2017ZDSYLL073-P01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No