ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000314224

Ethics application status

Approved

Date submitted

13/01/2017

Date registered

2/03/2018

Date last updated

2/03/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

A comparison of the efficacy of intermittent versus continuous infusions of vancomycin at achieving therapeutic concentrations in an adult Australian critically ill population.

Scientific title

A comparison of the efficacy of intermittent versus continuous infusions of vancomycin at achieving therapeutic concentrations in an adult Australian critically ill population.

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

sepsis

Condition category

Condition code

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This study is a before/after study design

The after phase begins after the implementation of a protocol for continuous intravenous infusions of vancomycin. This protocol consists of an intravenous infusion of a 25mg/kg loading dose, based on actual body weight, followed by a continuous infusion of vancomycin with initial dosing rates dictated by a protocol driven daily assessment of renal function using an estimated creatinine clearance. This protocol also involves daily therapeutic drug monitoring.

Creatinine clearance as per Cockcroft-Gault (Column 1) Total dose over 24 hours (Column 2) Infusion rate (Column 3)
Less than 10mL/min
10-21mL/min 750mg 3.8mL/hour
22-39mL/min 1000mg 5 mL/hour
40-57mL/min 1250mg 6.3 mL/hour
58-75mL/min 1500mg 7.5 mL/hour
76-93mL/min 1750mg 8.8 mL/hour
94-111mL/min 2000mg 10 mL/hour
112-129mL/min 2250mg 11.3 mL/hour
130-147mL/min 2500mg 12.5 mL/hour
148-165mL/min 2750mg 13.8 mL/hour
Greater than or equal to 166mL/min 3000mg 15 mL/hour

This data collection takes place over 7 months

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

The study is a before/after study design.

The before phase consists of observing standard practice of intravenous vancomycin (intermittent bolus dosing). This dosing varies depending on the patient- but is generally 1-2g every 12 hours.

This data collection takes place over 12 months

Control group

Active

Outcomes

Primary outcome [1]

Hours until therapeutic serum vancomycin concentration.

International guidelines define a therapeutic serum vancomycin concentration as measure of 15mg/L or greater for intermittent bolus dosing.

There is no consensus for a therapeutic serum vancomycin concentration when a continuous infusion is utilised, however common practice is greater than 20mg/L and that was what is to be used in this study.

Timepoint [1]

During the before phase serum vancomycin concentration monitoring is to occur at the discretion of the treating intensivist, with advice from pharmacy when required.

The protocol used in the after phase directs for daily concentration monitoring, until therapeutic concentrations have been achieved on consecutive days.

Primary outcome [2]

The number of vancomycin courses per treatment group that achieved a therapeutic concentration. A vancomycin course that achieves a therapeutic concentration, is defined as follows.
If at any point during treatment with vancomycin a serum concentration is returned greater than 15mg/L for the intermittent dosing group or 20mg/L for the continuous infusion group.

Timepoint [2]

While patients are recieving an intravenous infusion of vancomycin daily therapeutic drug monitoring takes place, until the completion of therapy.

Primary outcome [3]

Number of serum vancomycin concentrations in therapeutic range per treatment course.

International guidelines define a therapeutic serum vancomycin concentration range as measure of 15-20mg/L or greater for intermittent bolus dosing.

There is no consensus for a therapeutic serum vancomycin concentration when a continuous infusion is utilised, however common practice is greater than 20-25mg/L and that was what is to be used in this study.

Timepoint [3]

Secondary outcome [1]

Rates of nephrotoxicity.

This will be assessed by using the Cockroft-Gault equation, and comparing the change from start to end of vancomycin treatment course. Additionally the rates of patients requiring renal replacement therapy will also measured

Timepoint [1]

Duration of treatment course

Eligibility

Key inclusion criteria

- At least 24 hours of intravenous vancomycin therapy
- At least one serum vancomycin concentration measured

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- Non-intravenous vancomycin (ie. oral)
- Breastfeeding patients
- Pregnant patients

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other

Other design features

Before-and-After study design

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

114 treatment courses from 101 critically ill patients
Statistical analysis via SPSS
independent t test or Mann Whitney U test depending on distribution of data

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

1/02/2015

Date of last participant enrolment

Anticipated

Actual

30/09/2016

Date of last data collection

Anticipated

Actual

30/09/2016

Sample size

Target

166

Accrual to date

Final

101

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Flinders Medical Centre - Bedford Park

Recruitment postcode(s) [1]

5042 - Bedford Park

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Flinders Medical Centre

Address [1]

Flinders Medical Centre
Flinders Drive
Bedford Park
5042
South Australia

Country [1]

Australia

Primary sponsor type

Individual

Name

Mr Simon Potts

Address

c/o ICCU
Flinders Medical Centre
Flinders Drive
Bedford Park
5042
South Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Local Health Network Human Research Ethics Committee

Ethics committee address [1]

c/o Flinders Medical Centre 
Flinders Drive
Bedford Park
SA
5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/01/2016

Approval date [1]

17/03/2016

Ethics approval number [1]

371.15

Summary

Brief summary

Vancomycin is an intravenous antibiotic used in the treatment of serious infections, commonly seen in the Intensive and Critical Care Unit (ICCU). Unlike many antibiotics, vancomycin requires serum drug concentration monitoring to ensure both efficacy and safety. Traditionally vancomycin is dosed as an intravenous intermittent infusion every 8-12 hours. However, critically ill patients experience greater pharmacokinetic changes which can have a major impact on the dosage of vancomycin required to treat infection. There is emerging evidence to suggest that the administration of vancomycin by a continuous infusion may be more efficacious in achieving therapeutic serum concentrations, doing so promptly, and limiting nephrotoxicity which is a known adverse effect of the drug. The aims of this project are as follows
1. To evaluate the current practice administering vancomycin by intermittent infusion within the ICCU at Flinders Medical Centre (FMC)- phase one/Before
2. To develop and implement a protocol for the administration of vancomycin by continuous infusion- phase two/Implementation
3. By using a Before-and-After study design evaluate the efficacy of a protocol for the administration of vancomycin by continuous infusions, when compared to standard practice within the ICCU at FMC- phase three/After
Data on the current practice of vancomycin dosing via intermittent infusion was commenced in February 2015, this data formed the basis for the Before group. The protocol was developed, using a dosing nomogram derived from a series of published studies identified from a literature review on the topic. This protocol
underwent beta-testing and was implemented into the ICCU in March 2016 with concurrent education sessions. Prospective post-implementation data collection was undertaken, making up the After group.

Trial website

Trial related presentations / publications

Public notes

Data collection started as an audit of current practice, as such ethics approval was not required until the initiation of the After phase

Contacts

Principal investigator

Name

Mr Simon Potts

Address

C/O ICCU
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia
5042

Country

Australia

Phone

+61 8 8204 6807

Fax

simon.potts@sa.gov.au

Contact person for public queries

Name

Simon Potts

Address

C/O ICCU
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia
5042

Country

Australia

Phone

+61 8 8204 6807

Fax

simon.potts@sa.gov.au

Contact person for scientific queries

Name

Simon Potts

Address

C/O ICCU
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia
5042

Country

Australia

Phone

+61 8 8204 6807

Fax

simon.potts@sa.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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