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

NCT03308214 | Completed DMC

• 1 other identifier: 2017ZDSYLL073-P01
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Septic Shock

Keywords

septic shock; imipenem; VD ;pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• the apparent volume of distribution

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

  Day1, Day 3, Day 7

Study Arms (2)

septic shock

Patients with septic shock treat with Imipenem

Drug: Imipenem

non-septic shock

Patients with infection but not septic shock treat with Imipenem

Drug: Imipenem

Interventions

Imipenem DRUG

Imipenem 1.0 q 8h

non-septic shock; septic shock

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Location

Related Publications (1)

• 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.

  PMID: 32176787 DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

Imipenem

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Songqiao Liu, PHD

  Study Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PHD

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: October 12, 2017
• Study Start: March 18, 2018
• Primary Completion: December 28, 2018
• Study Completion: December 28, 2018
• Last Updated: January 5, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)