Intensive Care Clinical Trial
— MSBVOfficial title:
Determining Drug Levels of Beta-lactam Antibiotics in Severe Burned Patients
Verified date | November 2017 |
Source | University of Schleswig-Holstein |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
At antibiotic stewardship of the University Hospital of Schleswig-Holsten it was noticed that there are much less studies measuring drug levels in severe burned patients than are required. Especially, severe burned patient developing a capillary leak might show lower drug levels than patients without a capillary leak. To compare drug levels of beta-lactam antibiotics, it is the aim of this study to measure pharmacokinetics of Piperacillin/Tazobactam in ICU patients with and without severe burns.
Status | Completed |
Enrollment | 35 |
Est. completion date | December 31, 2016 |
Est. primary completion date | May 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: General - 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: - Already in another Study - No useful blood sample |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Schleswig-Holstein | Lübeck | Schleswig-Holstein |
Lead Sponsor | Collaborator |
---|---|
University of Schleswig-Holstein | Dezernat Apotheke, Medical Clinic III |
Germany,
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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
Roberts JA. Using PK/PD to optimize antibiotic dosing for critically ill patients. Curr Pharm Biotechnol. 2011 Dec;12(12):2070-9. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission |
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