Does continuous cefotaxime administration improve time to attainment and maintenance of target drug levels in intensive care patients?

Completed

• Conditions: bacterial pneumonia; selective decontamination of the digestive tract; 10004018

• Registration Number: NL-OMON41771
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

- Adult (>= 18 yrs. of age) patients
- Admitted to intensive care
- Indication for treatment with cefotaxime (as judged by treating physician)

Exclusion Criteria

Renal replacement therapy
Contraindications for cefotaxime use
No indication for an arterial line

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Total bound and unbound plasma concentrations of cefotaxime; target attainment<br /><br>and maintenance at different time intervals based on a predefined target<br /><br>minimal inhibitory concentration (MIC)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Describing cefotaxime PK parameters<br /><br>Parameters relevant to pharmacokinetic profile of subjects; including ideal<br /><br>body weight (kgs), actual body weight (kgs), fluid balance (L), creatinine<br /><br>(mg/mL), creatinine clearance (mL/min), derived from creatinine concentration<br /><br>in plasma and a 24-hour aliquot of urine, volume of distribution (total drug<br /><br>dose (mgs) divided by plasma cefotaxime concentration (mg/L)), albumin (mg/mL).<br /><br>To identify relationships between patient characteristics (e.g. APACHE II<br /><br>score, serum albumin concentration, kidney function etc.) and cefotaxime levels<br /><br>that can contribute to optimized dosing in selected patientgroups using<br /><br>multiple regression. </p><br>