Determining Drug Levels of Beta-lactam Antibiotics in Severe Burned Patients

Completed

• Conditions: Severe Burn; Antibiotics; Intensive Care
• Interventions: Diagnostic Test: Drug Level Monitoring

• Registration Number: NCT03335137
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-01
• Primary Completion: 2016-05-31
• Study Completion: 2016-12-31
• Study First Submitted: 2017-10-24
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-06
• Last Update Submitted: 2017-11-06
• Study First Posted: 2017-11-07
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU Patients with Severe Burns	Drug Level Monitoring	Patients suffering from severe burns treated on a burn unit - Drug Level Monitoring Piperacillin/Tazobactam
ICU Patients without Burns - Drug Level Monitoring	Drug Level Monitoring	Patient suffering from disease treated on an ICU - Drug Level Monitoring Piperacillin/Tazobactam

Primary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

University Hospital Schleswig-Holstein; 🇩🇪 Lübeck, Schleswig-Holstein, Germany