Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05349305 |
| Other study ID # |
byssc1985 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 30, 2022 |
| Est. completion date |
July 30, 2024 |
Study information
| Verified date |
April 2022 |
| Source |
The Second Hospital of Shandong University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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Therefore, the traditional pharmacokinetic study is no longer applicable, and it can't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.
