A New Protocol for Continuous Vancomycin Infusion Dosing.

Completed

• Conditions: Vancomycin Treatment; Sepsis

• Registration Number: NCT05143645
• Lead Sponsor: Karolinska University Hospital

Brief Summary

This observational study prospectively collect data on chosen dosing, renal function, measured plasma concentrations and adherence to the recommended clinical protocl for ICU patients treated with continuous vancomycin infusion.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-01
• Study First Submitted: 2019-11-03
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-22
• Last Update Submitted: 2021-11-22
• Study First Posted: 2021-12-03
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Start of continuous vancomycin infusion during the course of intensive care and at least one measurement of plasma concentration.

Exclusion Criteria

• Vancomycin treatment within 96 h before admission to the unit.
• Vancomycin treatment started with intermittent bolus infusions.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time (days) from start of treatment to first measurement of a plasma vancomycin concentration between 20 and 25 mg/mL	Until the end of treatment or discharge from unit	The title is a full description.
Relationship between time to intended concentration (15-20 mg/L) and adherence to the dosing protocol (% complete adherence).	Until the end of treatment or discharge from unit	For each patient the actually administired dose of vancomycin will be compared to the recommendation in the dosing protocol. The time to the intended concentration will be compared between patients with 100% adherence to the recommendations and for patients with dosing not following the recommendations.

Secondary Outcome Measures

Name	Time	Method
Percentage of the total treatment duration with the intended plasma concentration 15-20 mg/L.	Until the end of treatment or discharge from unit	The title is a full description.
Relationship between Percentage of the total treatment duration with the intended plasma concentration (15-20 mg/L) and adherence to the dosing protocol.	Until the end of treatment or discharge from unit	The title in combination with the description of outcome 2 is a sufficient description.

Trial Locations

Locations (1)

Karolinska University Hospital Solna; 🇸🇪 Stockholm, Sweden