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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] 290733 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac surgery 301313 0
Condition category
Condition code
Cardiovascular 301066 301066 0 0
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] 296634 0
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] 300488 0
Body temperature measured in degree celsius via a pulmonary artery catheter..
Timepoint [1] 300488 0
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] 330078 0
Change in mean arterial blood pressure measured in millimetres of mercury (mmHg) via intra-arterial blood pressure monitoring.
Timepoint [1] 330078 0
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] 330079 0
Change in cardiac index via thermodilution using a pulmonary artery catheter.
Timepoint [2] 330079 0
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] 330080 0
Changes in heart rate in beats per minute (bts/min) via telemetry monitoring.
Timepoint [3] 330080 0
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] 330081 0
Changes in urinary output measured in milliltres via the indwelling urinary catheter.
Timepoint [4] 330081 0
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] 7106 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 14864 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 295163 0
Hospital
Name [1] 295163 0
Austin Hospital
Country [1] 295163 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
Heidelberg VIC 3084
Australia
Country
Australia
Secondary sponsor category [1] 293987 0
Individual
Name [1] 293987 0
Professor Rinaldo Bellomo
Address [1] 293987 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Australia
Country [1] 293987 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296512 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 296512 0
145 Studley Road
Heidelberg VIC 3084
Australia
Ethics committee country [1] 296512 0
Australia
Date submitted for ethics approval [1] 296512 0
25/08/2016
Approval date [1] 296512 0
26/08/2016
Ethics approval number [1] 296512 0
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] 1326 1326 0 0
/AnzctrAttachments/372015-20160826 LNR16Austin358 (Audit) Ethics Approval Letter.pdf (Ethics approval)

Contacts
Principal investigator
Name 71118 0
Prof Rinaldo Bellomo
Address 71118 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 71118 0
Australia
Phone 71118 0
+61 3 9496 5992
Fax 71118 0
+61 3 9496 3932
Email 71118 0
[email protected]
Contact person for public queries
Name 71119 0
Glenn Eastwood
Address 71119 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 71119 0
Australia
Phone 71119 0
+ 61 3 9496 4835
Fax 71119 0
+61 3 9496 3932
Email 71119 0
[email protected]
Contact person for scientific queries
Name 71120 0
Rinaldo Bellomo
Address 71120 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 71120 0
Australia
Phone 71120 0
+61 3 9496 5992
Fax 71120 0
+61 3 9496 3932
Email 71120 0
[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

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No documents have been uploaded by study researchers.

Documents added automatically
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