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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03308214
Recruitment Status : Unknown
Verified March 2018 by Songqiao Liu, Southeast University, China.
Recruitment status was:  Recruiting
First Posted : October 12, 2017
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Songqiao Liu, Southeast University, China

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

Condition or disease Intervention/treatment
Septic Shock 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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Analysis of Factors Influencing the Apparent Volume of Distribution of Imipenem in Septic Shock Patients
Actual Study Start Date : March 18, 2018
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
Drug Information available for: Imipenem

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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes 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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308214


Contacts
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Contact: Jie Yang, doctor 13776573077 732781400@qq.com
Contact: Yingzi Huang, PHD 8602583262550 Yz_huang@126.com

Locations
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China, Jiangsu
Zhongda Hospital, Southeast University Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Songqiao Liu, Doctor    +862583262550    lsongqiao@qq.com   
Sponsors and Collaborators
Southeast University, China
Investigators
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Principal Investigator: Songqiao Liu, PHD Study Investigator
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Songqiao Liu, MD. PHD, Southeast University, China
ClinicalTrials.gov Identifier: NCT03308214    
Other Study ID Numbers: 2017ZDSYLL073-P01
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Songqiao Liu, Southeast University, China:
septic shock; imipenem; VD ;pharmacokinetics
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Imipenem
Anti-Bacterial Agents
Anti-Infective Agents