ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616001670460p

Ethics application status

Submitted, not yet approved

Date submitted

11/11/2016

Date registered

5/12/2016

Date last updated

12/11/2018

Date data sharing statement initially provided

12/11/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Conservative use of intravenous fluid in critically ill adults - pilot study

Scientific title

Randomised controlled feasibility study of conservative versus usual fluid management in critically ill adults

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1189-7486

Trial acronym

Linked study record

Health condition

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

Critical illness

Shock

Condition category

Condition code

Other

Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention is a conservative fluid practice guideline, regarding the use intravenous fluids in adult patients who are admitted to ICU. The intention to minimise overall fluid exposure such that patients in this group will consistently receive an amount of fluid in the lower range of usual fluid exposure in ICU. The study procedures will continue until the patient is discharged from ICU or dies..

The guideline is categorised into 5 areas: maintenance fluid, replacement of ongoing fluid losses, bolus (resuscitation) fluid, drug and other infusions, and enteral nutrition. Maintenance fluid in the intervention group will be 0.5 ml/kg/hr. Fluid resuscitation boluses will be 250 ml in the intervention group. The study will accommodate and report deviations from the guideline where this is opted into by clinicians; adherence to the guideline will otherwise be encouraged as much as possible. Replacement of fluid losses will be prescribed separately to maintenance fluid in the conservative fluid guideline group. Fluids used for drug administration will be minimised by encouraging use of any existing local instructions for this purpose but will not be mandated or altered by the study. The intervention group guideline will prompt ICU staff to consider higher caloric density enteral feeds but this will not be mandated.

The guideline will be implemented by research staff via education of ICU staff. Unit-wide education sessions will be held for registrars, residents and nursing at the commencement of the study period. Staff caring for patients who are randomised will be detailed personally by research staff and provided with the guideline. Laminated card copies of the guideline will be attached to the bed area for patients who are in the study.

The guideline was developed by the authors of the study who are senior practicing Australian ICU clinicians (medical and nursing) with scientific experience in this area. The guideline development was also informed by a survey of more than 400 ICU clinicians in Australia concerning their beliefs and usual fluid practices.

A synopsis of the fluid guideline is attached to the ANZCTR registration form.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The intervention is a USUAL fluid practice guideline, regarding the use intravenous fluids in adult patients who are admitted to ICU. The intention to expose patients to an overall amount of intravenous fluid that is typical of the mid- or upper range of normal usage. The guideline is categorised into 5 areas: maintenance fluid, replacement of ongoing fluid losses, bolus (resuscitation) fluid, drug and other infusions, and enteral nutrition.

The guideline is categorised into 5 areas: maintenance fluid, replacement of ongoing fluid losses, bolus (resuscitation) fluid, drug and other infusions, and enteral nutrition. Maintenance fluid in the usual care group will be 1 ml/kg/hr. Fluid resuscitation boluses will be 500ml in the usual care group. The study will accommodate and report deviations from the guideline where this is opted into by clinicians; adherence to the guideline will otherwise be encouraged as much as possible. There will be no advice or instructions in the usual care group in the areas of fluid loss replacement, drug administration fluid, or enteral feeds.

The guideline will be implemented by research staff via education of ICU staff. Unit-wide education sessions will be held for registrars, residents and nursing at the commencement of the study period. Staff caring for patients who are randomised will be detailed personally by research staff and provided with the guideline. Laminated card copies of the guideline will be attached to the bed area for patients who are in the study.

The guideline was developed by the authors of the study who are senior practicing Australian ICU clinicians (medical and nursing) with scientific experience in this area. The guideline development was also informed by a survey of more than 400 ICU clinicians in Australia concerning their beliefs and usual fluid practices.

A synopsis of the fluid guideline is attached to the ANZCTR registration form

Control group

Active

Outcomes

Primary outcome [1]

Mean hourly fluid intake. This will be collected by ICU research staff who will review the daily flowsheet in the ICU.

Timepoint [1]

From the time of randomisation until 08:00 on the morning of day 2 post-randomisation

Secondary outcome [1]

Total fluid intake. This will be collected by ICU research staff who will review the daily flowsheet in the ICU.

Timepoint [1]

From the time of randomisation until 08:00 on the morning of day 7 post-randomisation (or ICU discharge if earlier than day 7)

Secondary outcome [2]

Cumulative fluid balance. This will be collected by ICU research staff who will review the daily flowsheet in the ICU.

Timepoint [2]

From the time of randomisation until 08:00 on the morning of day 2 and day 7 post-randomisation (or ICU discharge if earlier than day 7)

Secondary outcome [3]

Feasibility outcome - adherence to guideline: count of episodes of deviation from the fluid guideline, maintenance fluid rate. This will be collected but ICU research staff using the ICU flowsheet (medical record)

Timepoint [3]

Until time of ICU discharge or death

Secondary outcome [4]

Exploratory outcome: mortality. This will collected from the medical record by ICU research staff.

Timepoint [4]

At ICU and hospital dicharge

Secondary outcome [5]

Exploratory outcome: urine output. This will be collected by ICU research staff who will review the daily flowsheet in the ICU.

Timepoint [5]

At ICU discharge

Secondary outcome [6]

Cumulative fluid balance. This will be collected by ICU research staff who will review the daily flowsheet in the ICU.

Timepoint [6]

From the time of ICU admission until 08:00 on the morning of day 2 and day 7 post-randomisation (or ICU discharge if earlier than day 7)

Secondary outcome [7]

Median hourly fluid intake. This will be collected by ICU research staff who will review the daily flowsheet in the ICU.

Timepoint [7]

from the time of randomisation until 08:00 on the morning of day 2 post-randomisation

Secondary outcome [8]

Feasibility outcome - adherence to guideline: count of episodes of deviation from the fluid guideline, bolus fluid. This will be collected but ICU research staff using the ICU flowsheet (medical record)

Timepoint [8]