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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT02306928 |
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Date of registration:
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01/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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PK Analysis of Piperacillin in Septic Shock Patients
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Scientific title:
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Population Pharmacokinetics of Piperacillin in the Early Phase of Septic Shock - Does Standard Dosing Result in Therapeutic Plasma Concentrations? |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02306928 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Merete Storgaard, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Infectious Diseases, Aarhus University Hospital, Denmark |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Treatment with piperacillin/tazobactam for less than 24 hours. Treatment with
noradrenaline. -
Exclusion Criteria:
Renal replacement therapy. Age under 18.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Septic Shock
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Intervention(s)
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Other: Blood draw
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Primary Outcome(s)
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100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval.
[Time Frame: Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.]
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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.
[Time Frame: Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.]
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Secondary Outcome(s)
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The Maximum Concentration of Piperacillin (Cmax)
[Time Frame: Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.]
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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)
[Time Frame: Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.]
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Trough Piperacillin Plasma Concentration (Cmin)
[Time Frame: Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.]
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Secondary ID(s)
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PIP/TAZO-ICU
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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