Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000717853
Ethics application status
Approved
Date submitted
4/07/2012
Date registered
5/07/2012
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
Retrospectively registered

Titles & IDs
Public title
Fluid restriction compared to fluid optimisation with the oesophageal doppler in colorectal surgery: a randomized clinical trial of efficacy
Scientific title
The effect of fluid optimisation with the oesophageal doppler compared to fluid restriction on perioperative morbidity in major elective colorectal surgery with an Enhanced Recovery After Surgery protocol.
Secondary ID [1] 280669 0
Nil
Universal Trial Number (UTN)
U1111-1131-8049
Trial acronym
RESORT

"RES"trictive "OR T"argetted
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal surgery 286686 0
Fluid therapy intraoperative 286687 0
Perioperative morbidity 286688 0
Haemodynamic state intraoperative 286689 0
Condition category
Condition code
Anaesthesiology 286989 286989 0 0
Anaesthetics
Surgery 287157 287157 0 0
Other surgery
Oral and Gastrointestinal 287158 287158 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The fluid optimisation group will have an oesophageal doppler inserted after induction. A maintenance rate of Hartmann's solution at 6mls/kg/hr will run intravenously at the start to the end of the operative period. The anaesthetist will use the oesophageal doppler to administer colloid boluses intravenously (250mls Hydroxyethyl starch 130/0.4, Volulyte, Fresenius Kabi) based on the stroke volume and flow time parameters.
Intervention code [1] 285075 0
Treatment: Other
Comparator / control treatment
The control group will have a "restrictive" fluid regimen as follows:
Maintenance 6mls/kg/hr Hartmann's solution with boluses to replace blood loss. Boluses can be crystalloid or colloid or blood.
Control group
Active

Outcomes
Primary outcome [1] 287458 0
Complication rate: number of complications during hospital stay.
We will use a standardised classfication and severity grading scale, based on the work of Dindo and Clavien.
This has a 17 point classification of complications (eg. Venous thromboembolism, sepsis, AMI). The severity grading scale is a 7 point scale (from I - deviation from normal postoperative course without the need for intervention to V-death). Further details can be found at http://www.surgicalcomplication.info
Timepoint [1] 287458 0
at hospital discharge
Primary outcome [2] 322028 0
Length of Stay - defined by from date of admission to date of discharge.

Timepoint [2] 322028 0
At hospital discharge
Secondary outcome [1] 298191 0
Change in Velocity Time Integral on Doppler examination across the Left Ventricular Outflow Tract.
Timepoint [1] 298191 0
At the beginning and end of surgery
Secondary outcome [2] 298192 0
Change in the stroke volume and cardiac output using intraoperative trans thoracic echocardiography.
Timepoint [2] 298192 0
At the beginning and end of surgery
Secondary outcome [3] 298193 0
Volume of fluid administration
Timepoint [3] 298193 0
Intraoperative
Secondary outcome [4] 298194 0
Vasopressor use
Timepoint [4] 298194 0
Intra-operative and until discharge from the recovery unit.

Eligibility
Key inclusion criteria
Elective major colorectal surgery
>18yrs of age
Enrollment into the Enhance Recovery After Surgery clinical care pathway.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Emergency surgery
Significant renal impairment
Hepatic dysfunction
Oesophageal pathology that is a contraindication to a oesophageal doppler probe
Inability to give informed consent
Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Randomisation will be stratified according to whether the patient is anticipated to have a STOMA or NO STOMA pathway.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/06/2012
Actual
17/04/2012
Date of last participant enrolment
Anticipated
Actual
19/12/2013
Date of last data collection
Anticipated
Actual
1/02/2014
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15273 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 28582 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 285563 0
Hospital
Name [1] 285563 0
St Vincent's Hospital Research Endowment Fund
Country [1] 285563 0
Australia
Primary sponsor type
Individual
Name
Dr Tuong Dien Phan
Address
PO Box 2900
Department of Anaesthesia
St Vincent's Hospital
Fitzroy Victoria 3065
Country
Australia
Secondary sponsor category [1] 284400 0
None
Name [1] 284400 0
Address [1] 284400 0
Country [1] 284400 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287578 0
St Vincent's HREC
Ethics committee address [1] 287578 0
41 Victoria Pde
Fitzroy Victoria 3065
Ethics committee country [1] 287578 0
Australia
Date submitted for ethics approval [1] 287578 0
Approval date [1] 287578 0
20/03/2012
Ethics approval number [1] 287578 0
039_12
Ethics committee name [2] 287579 0
St Vincent's Private Ethics Committee
Ethics committee address [2] 287579 0
59-61 Victoria Pde
Fitzroy Victoria 3065
Ethics committee country [2] 287579 0
Australia
Date submitted for ethics approval [2] 287579 0
26/06/2012
Approval date [2] 287579 0
Ethics approval number [2] 287579 0
HREC-D 039/12

Summary
Brief summary
During surgery on the bowel it is routine to replace blood and fluid loss with intravenous fluids. However, it is still unclear what the optimal amount and method is to replace this loss. This study compares giving a smaller amount of fluid, called fluid restriction, to giving fluid guided by a cardiac output monitor, called targetted fluid administration. We will assess the impact these two methods have on patient's recovery and also the effect on observed clinical signs such as cardiac output at the end of the operation.
Trial website
Trial related presentations / publications
Phan T, An V, Dsouza B, Rattray M, Johnston M, B Cowie. A randomised controlled trial of fluid restriction compared to oesophageal Doppler-guided goal-directed fluid therapy in elective major colorectal surgery within an Enhanced Recovery After Surgery program. Anaesth Intensive Care, 2014. 42(6): p. 752-60
Public notes

Contacts
Principal investigator
Name 34308 0
Dr Tuong Phan
Address 34308 0
PO BOX 2900
Department of Anaesthesia
St Vincent's Hospital Melbourne
FITZROY VIC 3065
Country 34308 0
Australia
Phone 34308 0
+61 3 92882253
Fax 34308 0
Email 34308 0
[email protected]
Contact person for public queries
Name 17555 0
Dr Dr Tuong D Phan
Address 17555 0
Mail:
PO Box 2900
Department of Anaesthesia
St Vincent's Hospital
Fitzroy Vic 3065
Country 17555 0
Australia
Phone 17555 0
+61 3 92882253
Fax 17555 0
+61 3 9288 4255
Email 17555 0
[email protected]
Contact person for scientific queries
Name 8483 0
Dr Dr Tuong D Phan
Address 8483 0
Mail:
PO Box 2900
Department of Anaesthesia
St Vincent's Hospital
Fitzroy Vic 3065
Country 8483 0
Australia
Phone 8483 0
+61 3 92882253
Fax 8483 0
+61 3 9288 4255
Email 8483 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 sharing of data not explicitly obtained.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5778Ethical approval    362630-(Uploaded-25-07-2019-10-24-52)-Study-related document.pdf
5780Informed consent form    362630-(Uploaded-30-07-2019-12-29-54)-Study-related document.doc



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Phan T, An V, Dsouza B, Rattray M, Johnston M, B C... [More Details]
Basic resultsNo 362630-(Uploaded-18-11-2019-16-44-24)-Basic results summary.pdf
Plain language summaryNo 1. Research question This study investigates whet... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIA Randomised Controlled Trial of Fluid Restriction Compared to Oesophageal Doppler-Guided Goal-Directed Fluid Therapy in Elective Major Colorectal Surgery within an Enhanced Recovery after Surgery Program2014https://doi.org/10.1177/0310057x1404200611
N.B. These documents automatically identified may not have been verified by the study sponsor.