A New Protocol for Continuous Vancomycin Infusion Dosing.

Sepsis Clinical Trial

— CVIP  

Official title:

Evaluation of a New Clinical Protocol for Dose Selection of Vancomycin for Continuous Infusion in ICU Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05143645
• Other study ID #: K 2019-9605
• Status: Completed
• Start date: September 1, 2013
• Est. completion date: March 31, 2020

Study information

• Verified date: November 2021
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis

Intervention

Other:
• Plasma vancoymcin measurements

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital Solna	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time (days) from start of treatment to first measurement of a plasma vancomycin concentration between 20 and 25 mg/mL	The title is a full description.	Until the end of treatment or discharge from unit
Primary	Relationship between time to intended concentration (15-20 mg/L) and adherence to the dosing protocol (% complete adherence).	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.	Until the end of treatment or discharge from unit
Secondary	Percentage of the total treatment duration with the intended plasma concentration 15-20 mg/L.	The title is a full description.	Until the end of treatment or discharge from unit
Secondary	Relationship between Percentage of the total treatment duration with the intended plasma concentration (15-20 mg/L) and adherence to the dosing protocol.	The title in combination with the description of outcome 2 is a sufficient description.	Until the end of treatment or discharge from unit