Population Pharmacokinetics of Lassila Tazobactam in Patients After Aortic Dissection

Sponsor
The Second Hospital of Shandong University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05349305
Collaborator
(none)
50
27

Study Details

Study Description

Brief Summary

The individualized drug use research on optimizing piperacillin tazobactam for CRRT of hospital-acquired pulmonary infection after cardiopulmonary bypass is still in the initial stage at home and abroad, lacking systematic research data. With the help of the population pharmacokinetic model, it can help clinicians to formulate individualized drug administration plans for such patients and provide methodological and data support for precise treatment. The rational use of piperacillin tazobactam will play an important role in reducing the use of carbapenems and curbing the occurrence of drug resistance.

Condition or Disease Intervention/Treatment Phase
  • Drug: continuous renal replacement therapy

Detailed Description

The incidence of acute renal failure after aortic dissection can be as high as 30%. In order to reduce mortality, most patients need continuous renal replacement therapy (CRRT). The concentration of antimicrobial drugs in patients receiving CRRT is often lower than the treatment level, which leads to treatment failure. The drug clearance rate of critically ill patients may change every day and it is difficult to estimate, especially when the renal function deteriorates and CRRT begins.

As a time-dependent antimicrobial drug, increasing the% t > MIC of piperacillin tazobactam is closely related to ensuring clinical efficacy. However, the molecular weight of piperacillin tazobactam is less than 2000 d, which can easily pass through the filter membrane. All CRRT methods have the same clearance rate. Meanwhile, the binding rate of piperacillin and tazobactam to plasma protein is only about 30%, which is easy to clear through CRRT. As a result, the curative effect of piperacillin tazobactam in treating hospital-acquired pneumonia after aortic dissection is not good according to the conventional dosage and administration. More and more doctors will consider choosing carbapenems as soon as possible, which is related to national health.

Therefore, the traditional pharmacokinetic study is no longer applicable, and it can't provide a basis for clinical determination of individualized drug use plan of piperacillin and tazobactam, while the population pharmacokinetic study can effectively solve this problem. The frequency of blood collection from patients is low (usually 2 ~ 4 blood collection points), which is the most advanced method for individualized drug use research in the world at present [10]. Methods The Nonlinear mixed effect Model (non-MEM) was used to calculate the average and variability of pharmacokinetic parameters in patients, and the synergistic effect of patient factors (such as age and weight) on pharmacokinetic parameters could be evaluated, thus providing a reliable basis for formulating individualized and accurate drug administration plan and improving the success rate of anti-infection.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Population Pharmacokinetics and Individualized Administration of Lassila Tazobactam in Patients Undergoing CRRT After Aortic Dissection
Anticipated Study Start Date :
Apr 30, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jul 30, 2024

Outcome Measures

Primary Outcome Measures

  1. blood concentration [Up to 8 hours after administration]

    Blood concentration of piperacillin and tazobactam in whole period after administration

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Cardiopulmonary bypass during aortic dissection, Lung infection, Continuous renal replacement therapy

Exclusion Criteria:

Intracranial infection, Urinary tract infection

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The Second Hospital of Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Second Hospital of Shandong University
ClinicalTrials.gov Identifier:
NCT05349305
Other Study ID Numbers:
  • byssc1985
First Posted:
Apr 27, 2022
Last Update Posted:
Apr 27, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by The Second Hospital of Shandong University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2022