ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616001730493

Ethics application status

Approved

Date submitted

12/12/2016

Date registered

16/12/2016

Date last updated

16/11/2018

Date data sharing statement initially provided

16/11/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Quality improvement initiative evaluating the physiological impact of 'room temperature' and 'warmed' fluid bolus therapy in cardiac surgical patients admitted to the intensive care unit

Scientific title

Quality improvement initiative in the ICU: A before-and-after practice change audit of warmed fluid bolus therapy in cardiac surgical patients admitted to the intensive care unit

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Cardiac surgery

Condition category

Condition code

Cardiovascular

Coronary heart disease

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

7

Target follow-up type

Days

Description of intervention(s) / exposure

We will evaluate the degree of physiological change over a four-hour period for the initial intravenous 500ml fluid bolus therapy (room temperature or warmed to 37 degrees) following admission to the intensive care unit for cardiac surgery when a fluid bolus is deemed clinically appropriate by the patient's treating clinician.

Intervention code [1]

Not applicable

Comparator / control treatment

The treatment administered to patients in the 'before' period is that of 'room temperature' fluid bolus therapy with data collected for patients admitted to ICU in the period of 4 months prior to implementation of warmed fluid bolus therapy.

Control group

Historical

Outcomes

Primary outcome [1]

Body temperature measured in degree celsius via a pulmonary artery catheter..

Timepoint [1]

Measured immediately prior to, at, 2 hours, 3 hours and 4 hours following the initial intravenous fluid bolus being administered post-cardiac surgery.

Secondary outcome [1]

Change in mean arterial blood pressure measured in millimetres of mercury (mmHg) via intra-arterial blood pressure monitoring.

Timepoint [1]

Measured immediately prior to, at, 2 hours, 3 hours and 4 hours following the initial intravenous fluid bolus being administered post-cardiac surgery.

Secondary outcome [2]

Change in cardiac index via thermodilution using a pulmonary artery catheter.

Timepoint [2]

Measured immediately prior to, at, 2 hours, 3 hours and 4 hours following the initial intravenous fluid bolus being administered post-cardiac surgery.

Secondary outcome [3]

Changes in heart rate in beats per minute (bts/min) via telemetry monitoring.

Timepoint [3]

Measured immediately prior to, at, 2 hours, 3 hours and 4 hours following the initial intravenous fluid bolus being administered post-cardiac surgery.

Secondary outcome [4]

Changes in urinary output measured in milliltres via the indwelling urinary catheter.

Timepoint [4]

Measured immediately prior to, at, 2 hours, 3 hours and 4 hours following the initial intravenous fluid bolus being administered post-cardiac surgery.

Eligibility

Key inclusion criteria

Adult (age 18 years or over)
Intensive Care unit admission
Cardiac surgical procedure performed
Clinician decides to administer bolus fluid therapy

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

Receiving extra-corporeal membrane oxygenation (ECMO)
Body surface cooling in place
Clinically indicated need for an intravenous bolus fluid other than compound sodium lactate (e.g. to treat high serum potassium states)

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Convenience sample

Timing

Both

Statistical methods / analysis

Variables will be assessed for normality and log-transformed if appropriate. Baseline comparisons will be performed using Fisher’s exact tests and reported as n (%). Continuous normally distributed variables will be compared using Student t-tests and reported as means (standard deviation), while non-normally distributed data will be compared using Wilcoxon rank-sum tests and reported as medians [interquartile range]. Changes over time will be determined using repeated measures mixed linear modelling with each patient treated as a random effect, and therapy group, time and the interaction of therapy group and time as effect fixed effects. A two-sided p-value < 0.05 was considered evidence of a significant difference between standard care before and care after the introduction of the quality improvement initiative.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

19/12/2016

Actual

4/01/2017

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

50

Accrual to date

38

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Hospital

Address [1]

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Australia

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

145 Studley Road
Heidelberg VIC 3084
Australia

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Professor Rinaldo Bellomo

Address [1]

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

145 Studley Road
Heidelberg VIC 3084
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/08/2016

Approval date [1]

26/08/2016

Ethics approval number [1]

LNR/16/Austin/358

Summary

Brief summary

Patients who undergo cardiac surgery are routinely cared for in the intensive care unit immediately following their operation. During part of the surgery, the patient’s circulating blood is diverted through a machine that essentially replicates the function of the heart and lungs (cardiopulmonary bypass). This occurs so that blood can be diverted from the heart so that the surgeon can operate safely. At this point the patient is cooled to prevent damage to the brain and heart that may occur whilst their blood circulation is dependent on cardiopulmonary bypass.
Patients are transferred to the intensive care unit still cold (hypothermic) and warm up passively and through external warming blankets with time. However, hypothermia can last for hours, have adverse effects, such as inhibiting the blood’s normal clotting mechanisms, and causing shivering and is made worse by the common administration of room temperature fluids.
Low blood pressure (hypotension) is a common problem encountered in patients during cardiac surgery and also in the intensive care unit afterward. If untreated, hypotension can lead to dysfunction of vital organs and even death. Often the first intervention to treat low blood pressure is administration of intravenous fluid into the patient’s vein. Typically, a discrete volume (e.g. 500 ml) is given rapidly as a “bolus” to improve the patient’s blood pressure. The rationale is that the intravenous fluid will increase the patient’s blood volume, leading to an increase in blood pressure and cardiac output (volume of blood pumped by the heart over one minute).
It is common practice for patients to receive fluid that has been warmed to normal human body temperature (37oC) whilst in the operating theatre to prevent the adverse effects of hypothermia. However, common practice in the intensive care unit is to administer intravenous fluids that have been stored at room temperature (approximately 20 – 22oC). The use of room temperature fluids is likely to worsen hypothermia and therefore potentially increase the risk of bleeding, as well as causing shivering – which may require the administration of sedative medications.
Given the above concerns, the intensive care consultant group will be introducing the use of warmed intravenous fluid bolus therapy to patients cared for in the intensive care unit following cardiac surgery. After such introduction of warm fluid therapy, we plan to systematically audit the haemodynamic impact of this practice change.  Importantly, we will audit the feasibility of this practice change and ensure whether it achieves our intended aim of decreasing the time taken for patients to warm up to a normal body temperature.  In addition, we wish to assess whether, as expected, a warmed bolus of fluid therapy results in a different effect on blood pressure as compared to a bolus of identical volume of room temperature fluid.  This audit will take a similar path to the recent conservative oxygen therapy trial, where a practice change allowed slightly lower than usual oxygen levels to be targeted at Austin Hospital, a before and after audit was conducted and showed clear benefits in patient outcomes including an increase in earlier spontaneous ventilation thus leading to the embedding of such therapy into practice based on clear data from the quality improvement cycle. The introduction of warmed fluids will follow the same quality improvement assessment cycle.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/372015-20160826 LNR16Austin358 (Audit) Ethics Approval Letter.pdf (Ethics approval)

Contacts

Principal investigator

Name

Prof Rinaldo Bellomo

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084

Country

Australia

Phone

+61 3 9496 5992

Fax

+61 3 9496 3932

Email

[email protected]

Contact person for public queries

Name

Glenn Eastwood

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084

Country

Australia

Phone

+ 61 3 9496 4835

Fax

+61 3 9496 3932

Email

[email protected]

Contact person for scientific queries

Name

Rinaldo Bellomo

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084

Country

Australia

Phone

+61 3 9496 5992

Fax

+61 3 9496 3932

Email

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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.