Determining Drug Levels of Beta-lactam Antibiotics in Severe Burned Patients
NCT ID: NCT03335137
Last Updated: 2017-11-07
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
35 participants
OBSERVATIONAL
2014-05-01
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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ICU Patients with Severe Burns
Patients suffering from severe burns treated on a burn unit - Drug Level Monitoring Piperacillin/Tazobactam
Drug Level Monitoring
Free (unbound) drug concentration 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission
ICU Patients without Burns - Drug Level Monitoring
Patient suffering from disease treated on an ICU - Drug Level Monitoring Piperacillin/Tazobactam
Drug Level Monitoring
Free (unbound) drug concentration 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission
Interventions
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Drug Level Monitoring
Free (unbound) drug concentration 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission
Eligibility Criteria
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Inclusion Criteria
* Adult
* Receiving beta-lactam antibiotic Piperacillin/Tazobactam
* Antibiotic therapy of 3 or more days
* Given informed consent Group 1
* Severe Burn Group 2
* No Severe Burn
Exclusion Criteria
* No useful blood sample
18 Years
ALL
No
Sponsors
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Medical Clinic III
UNKNOWN
Dezernat Apotheke
UNKNOWN
University Hospital Schleswig-Holstein
OTHER
Responsible Party
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Tobias Kisch
Principal Investigator
Principal Investigators
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Peter Mailänder, PhD
Role: STUDY_DIRECTOR
Plastic and Reconstructive Surgery, Hand Surgery, Burn Unit
Walter Raasch, PhD
Role: STUDY_CHAIR
Institute for experimental and clinical pharmacology and toxicology
Tobias Kisch, MD
Role: PRINCIPAL_INVESTIGATOR
Plastic and Reconstructive Surgery, Hand Surgery, Burn Unit
Locations
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University Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
Countries
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References
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Rafla K, Tredget EE. Infection control in the burn unit. Burns. 2011 Feb;37(1):5-15. doi: 10.1016/j.burns.2009.06.198. Epub 2010 Jun 18.
Roberts JA. Using PK/PD to optimize antibiotic dosing for critically ill patients. Curr Pharm Biotechnol. 2011 Dec;12(12):2070-9. doi: 10.2174/138920111798808329.
Blanchet B, Jullien V, Vinsonneau C, Tod M. Influence of burns on pharmacokinetics and pharmacodynamics of drugs used in the care of burn patients. Clin Pharmacokinet. 2008;47(10):635-54. doi: 10.2165/00003088-200847100-00002.
Patel BM, Paratz J, See NC, Muller MJ, Rudd M, Paterson D, Briscoe SE, Ungerer J, McWhinney BC, Lipman J, Roberts JA. Therapeutic drug monitoring of beta-lactam antibiotics in burns patients--a one-year prospective study. Ther Drug Monit. 2012 Apr;34(2):160-4. doi: 10.1097/FTD.0b013e31824981a6.
Olbrisch K, Kisch T, Thern J, Kramme E, Rupp J, Graf T, Wicha SG, Mailander P, Raasch W. After standard dosage of piperacillin plasma concentrations of drug are subtherapeutic in burn patients. Naunyn Schmiedebergs Arch Pharmacol. 2019 Feb;392(2):229-241. doi: 10.1007/s00210-018-1573-6. Epub 2018 Oct 27.
Other Identifiers
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13-275
Identifier Type: -
Identifier Source: org_study_id