NCT05143645

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
Last Updated

December 3, 2021

Status Verified

November 1, 2021

Enrollment Period

6.6 years

First QC Date

November 3, 2019

Last Update Submit

November 22, 2021

Conditions

SepsisVancomycin Treatment

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Percentage of the total treatment duration with the intended plasma concentration 15-20 mg/L.

    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.

    Until the end of treatment or discharge from unit

Interventions

Plasma vancoymcin measurementsOTHER

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU patients.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital Solna

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior ICU Consultant

Study Record Dates

First Submitted

November 3, 2019

First Posted

December 3, 2021

Study Start

September 1, 2013

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

December 3, 2021

Record last verified: 2021-11

Locations

SE(1)