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OpenTrials
Completed

NCT Number: NCT05143645

A New Protocol for Continuous Vancomycin Infusion Dosing.

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome Vancomycin Treatment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital Solna

Stockholm, 17176, Sweden

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plasma vancoymcin measurements

Other

Primary outcomes

  1. Time (days) from start of treatment to first measurement of a plasma vancomycin concentration between 20 and 25 mg/mL

    Time frame: Until the end of treatment or discharge from unit

    The title is a full description.

  2. Relationship between time to intended concentration (15-20 mg/L) and adherence to the dosing protocol (% complete adherence).

    Time frame: 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 outcomes

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

    Time frame: Until the end of treatment or discharge from unit

    The title is a full description.

  2. Relationship between Percentage of the total treatment duration with the intended plasma concentration (15-20 mg/L) and adherence to the dosing protocol.

    Time frame: Until the end of treatment or discharge from unit

    The title in combination with the description of outcome 2 is a sufficient description.

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

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

Acronym: CVIP

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Dec 3, 2021
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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