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

NCT ID: NCT03308214

Last Updated: 2021-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-18

Study Completion Date

2018-12-28

Brief Summary

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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

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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.

Conditions

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Septic Shock

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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septic shock

Patients with septic shock treat with Imipenem

Imipenem

Intervention Type DRUG

Imipenem 1.0 q 8h

non-septic shock

Patients with infection but not septic shock treat with Imipenem

Imipenem

Intervention Type DRUG

Imipenem 1.0 q 8h

Interventions

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Imipenem

Imipenem 1.0 q 8h

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southeast University, China

OTHER

Sponsor Role lead

Responsible Party

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Songqiao Liu

MD. PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Songqiao Liu, PHD

Role: PRINCIPAL_INVESTIGATOR

Study Investigator

Locations

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Zhongda Hospital, Southeast University

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 32176787 (View on PubMed)

Other Identifiers

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2017ZDSYLL073-P01

Identifier Type: -

Identifier Source: org_study_id

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