Are Standard Dosing Regimens of Piperacillin-Tazobactam Suitable in Critically Ill Patients With Open Abdomen and Negative Pressure Wound Therapy? A Population Pharmacokinetic Study.
NCT ID: NCT04915872
Last Updated: 2023-02-27
Study Results
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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COMPLETED
46 participants
OBSERVATIONAL
2021-07-01
2023-01-27
Brief Summary
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According to current practice, piperacillin-tazobactam (PTZ) is widely used as part of empirical combined antibiotic therapy to treat severe abdominal infections in the critically ill patients. On the other hand, little is known about the impact of OA/NPT on antibiotics pharmacokinetics and pharmacodynamics (PK/PD) and the optimal dosing regimens in this population remain unclear.
As PTZ is a small hydrophilic molecule with a very low level of protein binding, invesitigators hypothesized that OA/NPT should lead to significant changes in volume of distribution (Vd) and/or drug clearance (CL
The main objective of this study was to assess the incidence of underdosing and the pharmacokinetics of piperacillin in critically ill patients with OA/NPT.
The secondary objective was to assess the appropriateness of recommended regimens for empirical minimum inhibitory concentration (MIC) coverage.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participant
Critically Ill Patients with Open Abdomen and Negative Pressure Wound Therapy
Blood sampling (T0, inclusion)
Blood sample (5 ml) at 30 minutes after the loading dose of 4g/0.5g over 30 minutes for therapeutic drug monitoring at peak concentration (Cmax)
other samplings (T1)
\- T1 : Day of the first surgical revision, under PTZ administered by continuous infusion : Blood sample (5 ml) for therapeutic drug monitoring at steady state concentration (Css).
Urinary sample and collection of urinary volume between T0 and T1 (Urinary Clearance) NPT fluid sample and collection of NPT volume between T0 and T1 (Peritoneal Clearance) Peritoneal sampling for therapeutic drug monitoring at the site of infection (CPt)
Interventions
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Blood sampling (T0, inclusion)
Blood sample (5 ml) at 30 minutes after the loading dose of 4g/0.5g over 30 minutes for therapeutic drug monitoring at peak concentration (Cmax)
other samplings (T1)
\- T1 : Day of the first surgical revision, under PTZ administered by continuous infusion : Blood sample (5 ml) for therapeutic drug monitoring at steady state concentration (Css).
Urinary sample and collection of urinary volume between T0 and T1 (Urinary Clearance) NPT fluid sample and collection of NPT volume between T0 and T1 (Peritoneal Clearance) Peritoneal sampling for therapeutic drug monitoring at the site of infection (CPt)
Eligibility Criteria
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Inclusion Criteria
* Admitted in surgical ICU for a suspected length of stay \> 3 days
* Receiving an antimicrobial therapy by PTZ
* For an intra-abdominal infection
* Under OA/NPT during antimicrobial therapy
* With urinary and arterial catheters
Exclusion Criteria
* Known allergy to PTZ
* Patient's refusal for participation to the research
* Patient unable to consent (dementia or severe psychiatric disorders, people under legal protection, people deprived of their liberty...)
* Pregnancy or breast-feeding
18 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Locations
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CHU de Bordeaux
Bordeaux, , France
Countries
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Other Identifiers
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CHUBX 2020/53
Identifier Type: -
Identifier Source: org_study_id
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