A New Protocol for Continuous Vancomycin Infusion Dosing. (CVIP)

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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Vancomycin Treatment
• Intervention / Treatment: Other: Plasma vancoymcin measurements

• Study Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17176
    • Karolinska University Hospital Solna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ICU patients.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2013
• Primary Completion (ACTUAL): March 31, 2020
• Study Completion (ACTUAL): March 31, 2020

Study Registration Dates

• First Submitted: November 3, 2019
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (ACTUAL): December 3, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 3, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: K 2019-9605

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No