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NCT Number: NCT03308214

The Analysis of Factors Influencing the Vd 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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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;
  • Pregnancy.
  • patients with ECMO and(or)CRRT.
  • tumors.

Treatment and study plan

Imipenem

Drug

Imipenem 1.0 q 8h

Primary outcomes

  1. the apparent volume of distribution

    Time frame: Day1, Day 3, Day 7

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

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 12, 2017
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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