Trial Outcomes & Findings for PK Analysis of Piperacillin in Septic Shock Patients (NCT NCT02306928)
NCT ID: NCT02306928
Last Updated: 2016-02-11
Results Overview
The piperacillin plasma concentration-time profiles were best described by a two-compartment model. Each individual model predicted T\>MIC was compared to clinical breakpoint MIC for P.aeruginosa (16 mg/L). The number of patients who achieved the pre-defined PK/PD target were reported.
Recruitment status
COMPLETED
Target enrollment
15 participants
Primary outcome timeframe
Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.
Results posted on
2016-02-11
Participant Flow
Participant milestones
| Measure |
Piperacillin Pharmacokinetics
Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.
Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered.
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|---|---|
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Overall Study
STARTED
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15
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Overall Study
COMPLETED
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15
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PK Analysis of Piperacillin in Septic Shock Patients
Baseline characteristics by cohort
| Measure |
Piperacillin Pharmacokinetics
n=15 Participants
Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.
Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered.
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Age, Continuous
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66 years
n=5 Participants
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Sex: Female, Male
Female
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4 Participants
n=5 Participants
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Sex: Female, Male
Male
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11 Participants
n=5 Participants
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Body weight
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80 kg
n=5 Participants
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PRIMARY outcome
Timeframe: Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.The piperacillin plasma concentration-time profiles were best described by a two-compartment model. Each individual model predicted T\>MIC was compared to clinical breakpoint MIC for P.aeruginosa (16 mg/L). The number of patients who achieved the pre-defined PK/PD target were reported.
Outcome measures
| Measure |
Piperacillin Pharmacokinetics
n=15 Participants
Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.
Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered.
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100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval.
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10 participants
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PRIMARY outcome
Timeframe: Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.The piperacillin plasma concentration-time profiles were best described by a two-compartment model. Each individual model predicted T\>MIC was compared to clinical breakpoint MIC for P.aeruginosa (16 mg/L). The number of patients who achieved the pre-defined PK/PD target were reported.
Outcome measures
| Measure |
Piperacillin Pharmacokinetics
n=15 Participants
Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.
Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered.
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|---|---|
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50% fT>4xMIC: Free Piperacillin Concentration Maintained at a Level Fourfold the MIC for at Least 50% of the Dosing Interval.
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12 participants
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SECONDARY outcome
Timeframe: Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.Maximum plasma concentration was predicted for each individual based on the final model fit.
Outcome measures
| Measure |
Piperacillin Pharmacokinetics
n=15 Participants
Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.
Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered.
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The Maximum Concentration of Piperacillin (Cmax)
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546 mg/L
Interval 363.0 to 668.0
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SECONDARY outcome
Timeframe: Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.Area under the free plasma concentration-time curve (fAUC0-8) was predicted for each individual based on the final model fit.
Outcome measures
| Measure |
Piperacillin Pharmacokinetics
n=15 Participants
Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.
Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered.
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The Area Under the Plasma-concentration Time Curve Concentration-time Curve From 0-8 Hours After the Studied Dose (AUC 0-8)
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1148 mg.hr/L
Interval 739.0 to 2492.0
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SECONDARY outcome
Timeframe: Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.Trough plasma concentration (Cmin) was predicted for each individual based on the final model fit.
Outcome measures
| Measure |
Piperacillin Pharmacokinetics
n=15 Participants
Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.
Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered.
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Trough Piperacillin Plasma Concentration (Cmin)
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51.7 mg/L
Interval 10.7 to 159.4
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Adverse Events
Piperacillin Pharmacokinetics
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kristina Öbrink-Hansen
Aarhus University Hospital, Department of infectious diseases
Phone: +45 7845 2845
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place