Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000125527
Ethics application status
Approved
Date submitted
28/01/2015
Date registered
11/02/2015
Date last updated
20/11/2019
Date data sharing statement initially provided
20/11/2019
Date results information initially provided
20/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
PreRELIEF - The haemodynamic consequence of restriction compared to liberal intravenous fluid therapy in patients undergoing major abdominal surgery.
Scientific title
The difference in the haemodynamics, including difference in stroke volume or preload responsiveness in patients randomised to the restrictive or liberal intravenous fluid therapy in major abdominal surgery.
Secondary ID [1] 285457 0
Nil Known
Universal Trial Number (UTN)
U1111-1162-6968
Trial acronym
PreRELIEF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Abdominal Surgery 293273 0
Fluid therapy intraoperative 293274 0
Haemodynamics, specifically stroke volume and preload responsiveness 293275 0
Condition category
Condition code
Anaesthesiology 293541 293541 0 0
Other anaesthesiology
Cardiovascular 294424 294424 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Restrictive fluid therapy a) intraoperative protocol of intravenous infusion: induction of anaesthesia Hartmann's solution <5mls/kg bolus, intraop maintenance rate 5mls/kg/hr, bolus colloid/blood to replace blood loss (ml for ml). b) postoperative protocol of intravenous infusion Hartmann's 0.8mls/kg/hr for 24hrs.

Haemodynamic variables to be assessed i. Doppler stroke volume, cardiac index, corrected flow time ii. pulse contour analysis stroke volume, cardiac index, pulse pressure variation iii. plethysmographic variability index, perfusion index. These variables will be assessed at the beginning of surgery and at the end of surgery with a passive leg raise manouvre.
Intervention code [1] 291050 0
Not applicable
Comparator / control treatment
Liberal fluid therapy a) intraoperative protocol of intravenous infusion: induction of anaesthesia Hartmann's solution 10mls/kg bolus, intraop maintenance rate 8mls/kg/hr, treat hypotension and hypovolemia with fluid boluses of colloid or crystalloid. b) postoperative protocol of intravenous infusion of Hartmann's solution 1.5mls/kg/hr for 24hrs.

Haemodynamic variables to be assessed i. Doppler stroke volume, cardiac index, corrected flow time ii. pulse contour analysis stroke volume, cardiac index, pulse pressure variation iii. plethysmographic variability index, perfusion index. These variables will be assessed at the beginning of surgery and at the end of surgery with a passive leg raise manouvre.
Control group
Active

Outcomes
Primary outcome [1] 293363 0
Difference in doppler derived stroke volume at the end of surgery between the Restrictive and Liberal groups.
Timepoint [1] 293363 0
End of surgery
Secondary outcome [1] 310854 0
Doppler derived corrected flow time
Timepoint [1] 310854 0
end of surgery
Secondary outcome [2] 310855 0
Pulse contour analysis Stroke volume index
Timepoint [2] 310855 0
end of surgery
Secondary outcome [3] 310856 0
Pulse contour analysis Pulse Pressure Variation
Timepoint [3] 310856 0
End of surgery
Secondary outcome [4] 312820 0
Plethysmographic variability Index
Timepoint [4] 312820 0
End of surgery
Secondary outcome [5] 312821 0
Proportion of patients who are fluid responsive.
A change in Doppler derived Stroke Volume Index of >10% with Passive Leg Raise
Timepoint [5] 312821 0
end of surgery

Eligibility
Key inclusion criteria
Patients must already be recruited the RELIEF trial (ClinicalTrials.gov Identifier: NCT01424150) which is currently recruiting.

Incusions criteria include adults over 18 years of age and
all types of open or laprascopic assisted abdominal or pelvic surgery with a duration of atleast 2 hours and an expected hospital stay of at least 3 days.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Urgent surgery
ASA 5
Chronic renal failure requiring dialysis
Pulmonary or Cardiac Surgery
Liver Ressection
Minor/Intermediate Surgery

in addition

Patients who may have an inappropriate response to PLR.
Patients with a contraindication to a PLR
Patients in whom an ODM cannot be placed
Patients in whom the primary anaesthetist chooses to use GDT

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Power analysis: increase in stroke volume of 43mls (sd 14) to 52(sd 17) using the oesophageal doppler.
Estimated sample size of 47 in each group (alpha=0.05, power=0.80). We would recruit a total of 100 to allow for drop outs and exclusions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/02/2015
Actual
1/06/2015
Date of last participant enrolment
Anticipated
Actual
21/09/2016
Date of last data collection
Anticipated
Actual
21/09/2016
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3367 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 3368 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 9154 0
3065 - Fitzroy
Recruitment postcode(s) [2] 9155 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 290090 0
Other Collaborative groups
Name [1] 290090 0
Australian and New Zealand College of Anaesthetists (ANZCA)
Country [1] 290090 0
Australia
Funding source category [2] 290646 0
Hospital
Name [2] 290646 0
St Vincent's Research Endowment Fund
Country [2] 290646 0
Australia
Primary sponsor type
Individual
Name
Dr Tuong Dien Phan
Address
PO Box 2900
Department of Anaesthesia
St Vincent's Hospital Melbourne
FITZROY VIC 3065
Country
Australia
Secondary sponsor category [1] 288789 0
None
Name [1] 288789 0
none
Address [1] 288789 0
Country [1] 288789 0
Other collaborator category [1] 278303 0
Individual
Name [1] 278303 0
Phil Peyton
Address [1] 278303 0
Dept of Anaesthesia
Level 2
Austin Tower
Austin Hospital
Studley Rd
Heidelberg 3084
VIC Australia
Country [1] 278303 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304775 0
Alfred Ethics committee
Ethics committee address [1] 304775 0
Commercial Road, Prahran, Vic 3084
Ethics committee country [1] 304775 0
Australia
Date submitted for ethics approval [1] 304775 0
01/11/2014
Approval date [1] 304775 0
29/01/2015
Ethics approval number [1] 304775 0
none

Summary
Brief summary
Disability free survival after major abdominal surgery is of importance to patients and their care givers. Replacement fluid given to patients is likely to make a difference to this outcome. The RELIEF study looks at a low volume compared to a high volume fluid replacement technique to determine which results in the best outcome.

What is relatively unknown is how these two different fluid replacement techniques change the cardiovascular signs that are frequently monitored as part of general anaesthetic care. These cardiovascular monitored signs can include the volume the heart pumps each beat (stroke volume) or the changes in cardiac volume over time (stroke volume variation). These cardiovascular signs are often used to guide how much fluid to give.

This is because we know that if the cardiac function does not meet the needs of the extra demands from surgery, it can result in harm to the patient. For example, the patient may require additional drugs to support their circulation or suffer from poor wound healing.

We aim to recruit 100 patients who are part of the RELIEF study to observe the changes in cardiovascular function using cardiac monitors.

These cardiac monitors are used as part of routine monitoring care and represent established approved devices in clinical monitoring.

The information from this study will help determine the usefulness of these signs for the specialist anaesthetic doctor looking after the patient. Careful and accurate monitoring of a patient’s condition can help a clinician tailor the fluid resuscitation for the patient. It can also help identify patients who may need extra support through additional drugs or closer monitoring.

As this is an observational study, there will be no direct benefit to the patient. However, the information gained from the study would be of use to clinicians better look after future patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51946 0
Dr Tuong Phan
Address 51946 0
Department Anaesthesia and Acute Pain
St Vincent's Hospital Melbourne
41 Victoria Parade
PO Box 2900
Fitzroy Vic 3065
Country 51946 0
Australia
Phone 51946 0
+61 3 92882211
Fax 51946 0
Email 51946 0
[email protected]
Contact person for public queries
Name 51947 0
Dr Tuong Phan
Address 51947 0
Department Anaesthesia and Acute Pain
St Vincent's Hospital Melbourne
41 Victoria Parade
PO Box 2900
Fitzroy Vic 3065
Country 51947 0
Australia
Phone 51947 0
+61 3 92882211
Fax 51947 0
Email 51947 0
[email protected]
Contact person for scientific queries
Name 51948 0
Dr Tuong Phan
Address 51948 0
Department Anaesthesia and Acute Pain
St Vincent's Hospital Melbourne
41 Victoria Parade
PO Box 2900
Fitzroy Vic 3065
Country 51948 0
Australia
Phone 51948 0
+61 3 92882211
Fax 51948 0
Email 51948 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent for public access to patient data was not explicitly obtained.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5783Ethical approval    367222-(Uploaded-24-07-2019-16-34-47)-Study-related document.pdf



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.