An observational study in Laparotomy, Critical Illness and Piperacillin, Tazobactam Drug Combination, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-27.
Sponsored by University Hospital, Bordeaux · Observational
For several years, open abdomen with temporary abdominal closure using Negative Pressure Therapy (OA/NPT) has become one of the leading strategies to treat or prevent intra-abdominal hypertension in critically ill surgical patients after a wide range of complex abdominal injuries and conditions.
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.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 46 is below the median of 130 across 867 observational studies indexed under Critical Illness.
Browse Critical Illness studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
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Critically Ill Patients with Open Abdomen and Negative Pressure Wound Therapy
Exclusion Criteria:
Critically Ill Patients with Open Abdomen and Negative Pressure Wound Therapy
Procedure: Blood sampling (T0, inclusion) · Procedure: other samplings (T1)
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)
- 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)
Rate of piperacillin
The main outcome investigated in this study was the rate of piperacillin (PIP) underdosing, arbitrarily defined by at least one of three samples under 16 mg/L. This threshold represents the highest MIC for Pseudomonas as per the European Committee on Antimicrobial Susceptibility Testing (EUCAST).
Time frame: T1 (Day of the first surgical revision, up to 72 hours after inclusion)
Plan to share: No
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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux