SepsisCVIPNCT05143645
A New Protocol for Continuous Vancomycin Infusion Dosing.
An observational study of Sepsis and Vancomycin Treatment, run by Karolinska University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Vancomycin Treatment
- What is being tested?
- Plasma vancoymcin measurements
- How many people
- 101 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2013to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: ICU patients.
Who may be able to join
- Start of continuous vancomycin infusion during the course of intensive care and at least one measurement of plasma concentration.
Who cannot join
- Vancomycin treatment within 96 h before admission to the unit.
- Vancomycin treatment started with intermittent bolus infusions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sepsis, Vancomycin Treatment
- Being tested
- Plasma vancoymcin measurements
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma vancoymcin measurementsOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
The title is a full description.
Measured: 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.
Measured: Until the end of treatment or discharge from unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Sep 2013
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Petersson, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143645
- Sponsor's protocol ID
- K 2019-9605
- Acronym
- CVIP
- Status last verified
- Nov 2021
- First submitted
- 3 Nov 2019
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Clinical Protocol for Dose Selection of Vancomycin for Continuous Infusion in ICU Patients.
- ClinicalTrials.gov ID
- NCT05143645
- Acronym / sponsor ID
- CVIP / K 2019-9605
- Conditions
- Sepsis, Vancomycin Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- ICU patients.
Key inclusion criteria (1 listed)
- Start of continuous vancomycin infusion during the course of intensive care and at least one measurement of plasma concentration.
Key exclusion criteria (2 listed)
- Vancomycin treatment within 96 h before admission to the unit.
- Vancomycin treatment started with intermittent bolus infusions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma vancoymcin measurements | Other | – |
Primary outcome
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.
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Vancomycin Treatment, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.