Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000558123
Ethics application status
Approved
Date submitted
4/04/2019
Date registered
10/04/2019
Date last updated
10/04/2019
Date data sharing statement initially provided
10/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Goal directed fluid therapy in patients undergoing major liver resection surgery: a retrospective comparative study
Scientific title
The effect goal directed fluid therapy (GDFT) on clinical outcomes in patients undergoing extended right hepatectomy: a single centre retrospective comparative study
Secondary ID [1] 297741 0
None
Universal Trial Number (UTN)
U1111-1230-2918
Trial acronym
Not applicable
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Liver resection 312071 0
Liver surgery 312072 0
Fluid management 312073 0
Condition category
Condition code
Surgery 310634 310634 0 0
Other surgery
Anaesthesiology 310635 310635 0 0
Other anaesthesiology
Oral and Gastrointestinal 310852 310852 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 310854 310854 0 0
Other metabolic disorders
Blood 310855 310855 0 0
Other blood disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This retrospective observational study will include the records of patients who have undergone right hepatectomy and received either traditional fluid intervention practice (i.e. fluid restriction and low central venous pressure anaesthesia) or Goal Directed Therapy (GDT). Both groups of patients have received a dedicated enhanced recovery after surgery (ERAS) program.

Goal-directed therapy utilizes monitoring techniques to help guide clinicians with administering fluids, vasopressors, inotropes, or other treatments to patients in various clinical settings. In our centre, the device we utilise for GDT is a FloTrac™ catheter (FloTrac System 4.0, Edwards Lifesciences, Irvine, CA, USA). This is attached to the participant’s arterial line and then connected to an EV1000 haemodynamic monitor (Edwards Lifesciences, Irvine, CA, USA). Data from this technology provides real time measurements of continuous blood pressure, cardiac and stroke volume index, stroke volume variation and systemic vascular resistance. Specific to patients undergoing major liver resection, we target a stroke volume variation of greater than 20% was used as a threshold for fluid intervention during the dissection and hepatic transection stages. During haemostasis and surgical closure, a stroke volume variation of greater than 15% is used as a fluid intervention target for restoration of euvolemia.

The ERAS program consists of avoidance of nasogastric tubes, early mobilisation with physiotherapy on the day of surgery, early free fluids (within two postoperative hours), early oral intake (within 6 postoperative hours), optimising analgesia with a dedicated acute pain team service), prophylactic use of anti-emetics, antibiotic prophylaxis, chemothrombotic prophylaxis, and daily postoperative physiotherapy.

We aim to compare impact of GDT group has on patients length of hospital stay, fluid use intraoperatively and post operatively, use of vasoactive drugs intraoperatively, and all post operative complications.

Patients will not be contacted in any way, and all information extracted from the records will be de-identified and aligned with hospital governance processes for clinical audit and retrospective data collection.
Intervention code [1] 314035 0
Not applicable
Comparator / control treatment
Control group will be patients who received standard fluid intraoperative intervention i.e. Goal directed therapy using a Flotrac catheter is NOT employed. All patients underwent a standard Enhanced Recovery After Surgery (ERAS) program.

We defined standard intraoperative fluid intervention for major liver resection surgery fluid therapy and use of vasoactive medications not guided by any advanced haemodynamic monitor i.e. where goal directed therapy has not been employed. Standard intraoperative fluid therapy and use of vasoactive therapy at all institutions was directed by routine invasive cardiovascular monitoring i.e. arterial line and central venous pressure. This entails maintenance of low CVP (less than 8 mmHg) during the pre-hepatic transection and dissection phases. Fluid restriction and reverse Trendelenburg positioning were employed to assist in low central venous pressure anaesthesia.

The ERAS program consists of avoidance of nasogastric tubes, early mobilisation with physiotherapy on the day of surgery, early free fluids (within two postoperative hours), early oral intake (within 6 postoperative hours), optimising analgesia with a dedicated acute pain team service), prophylactic use of anti-emetics, antibiotic prophylaxis, chemothrombotic prophylaxis, and daily postoperative physiotherapy.
Control group
Active

Outcomes
Primary outcome [1] 319550 0
Duration of hospital stay in hours. Data for length of stay will collected from our hospitals electronic medical records.
Timepoint [1] 319550 0
This will be calculated as number of hours beginning from surgical closure to hospital discharge.
Secondary outcome [1] 368642 0
Volume of fluid used intraoperatively in millilitres. This is the amount of fluid therapy administered by the attending anaesthetist that is documented on the patient's anaesthesia medical record. The information will be taken from this medical record.
Timepoint [1] 368642 0
Intraoperative: 30 minutes prior to induction of anaesthesia until completion of surgery (last surgical stitch).
Secondary outcome [2] 368643 0
Volume of fluid used postoperatively in millilitres. This is the amount of fluid therapy administered by the attending surgical and anaesthesia clinicians caring for the patients that is documented on the patient's medical record. Austin Health utilizes electronic medical records. The information will be taken directly from the electronic medical record.
Timepoint [2] 368643 0
Postoperative: At completion of surgery until the end of day 1 post operation.
Secondary outcome [3] 368644 0
Use of vasoactive drugs intraoperatively.This is the amount of vasoactive therapy (inclusive of vasopressors and inotropes) administered by the attending anaesthetist that is documented on the patient's anaesthesia medical record. The information will be taken from this medical record.
Timepoint [3] 368644 0
Intraoperative: 30 minutes prior to induction of anaesthesia until completion of surgery (last surgical stitch).
Secondary outcome [4] 368646 0
Postoperative complications. Postoperative complication will be any complication documented in the patients electronic medical record or clinical notes, including the patients discharge summary.

We will defined complications as unexpected deviations from standard care using the European Perioperative Clinical Outcome (EPCO) definitions. These definitions clearly define all postoperative complications including acute kidney injury, surgical site infection, pneumonia, acute myocardial infarction, postoperative delirium.

In addition we will define postoperative bile leak as the presence of bile in the drainage fluid that persisted on postoperative day 4 (as recorded in the patients's clinical notes or electronic medical records).

We will define postoperative acute pancreatitis as an elevation in serum lipase greater than three times the normal laboratory range.

All complications will be reviewed by two independent clinicians and then graded according to the Clavien-Dindo Classification. Any discrepancy was resolved by an independent clinician.
Timepoint [4] 368646 0
Postoperative: At completion of surgery until hospital discharge.

Eligibility
Key inclusion criteria
All patients (age >18 years) undergoing right hepatectomy with a standard ERAS (enhanced recovery after surgery) protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age less than 18 years
2. Patients who did not receive ERAS liver protocol prior to surgery
3. Patients undergoing left hepatectomy, minor resections, non-anatomy segemental reseections and wedge resections

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/01/2018
Date of last participant enrolment
Anticipated
Actual
1/04/2018
Date of last data collection
Anticipated
Actual
1/04/2018
Sample size
Target
58
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13478 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 26093 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 302267 0
Hospital
Name [1] 302267 0
Austin Hospital
Country [1] 302267 0
Australia
Primary sponsor type
Hospital
Name
Austin Hospital
Address
Department of Anaesthesia
Studley Road
Heidelberg, Victoria, 3084
Country
Australia
Secondary sponsor category [1] 302130 0
None
Name [1] 302130 0
Address [1] 302130 0
Country [1] 302130 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302943 0
Austin Health Human Reserach Ethics Committee
Ethics committee address [1] 302943 0
Ethics committee country [1] 302943 0
Australia
Date submitted for ethics approval [1] 302943 0
05/10/2015
Approval date [1] 302943 0
26/10/2015
Ethics approval number [1] 302943 0
LNR/15/321

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91926 0
A/Prof Laurence Weinberg
Address 91926 0
Department of Anaesthesia
Austin Hospital, 145 Studley Road, Heidelberg, 3084, Victoria
Country 91926 0
Australia
Phone 91926 0
+61 3 9496 5000
Fax 91926 0
+61 3 9459 6421
Email 91926 0
[email protected]
Contact person for public queries
Name 91927 0
Laurence Weinberg
Address 91927 0
Department of Anaesthesia
Austin Hospital, 145 Studley Road, Heidelberg, 3084, Victoria
Country 91927 0
Australia
Phone 91927 0
+61 3 9496 5000
Fax 91927 0
+61 3 9459 6421
Email 91927 0
[email protected]
Contact person for scientific queries
Name 91928 0
Laurence Weinberg
Address 91928 0
Department of Anaesthesia
Austin Hospital, 145 Studley Road, Heidelberg, 3084, Victoria
Country 91928 0
Australia
Phone 91928 0
+61 3 9496 5000
Fax 91928 0
+61 3 9459 6421
Email 91928 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
Deidentified data will be available from the Principle study investigator upon reasonable request. As this is a retrospective study, patients did not provide consent for data to be made available.


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
SourceTitleYear of PublicationDOI
EmbaseImpact of a goal directed fluid therapy algorithm on postoperative morbidity in patients undergoing open right hepatectomy: A single centre retrospective observational study.2019https://dx.doi.org/10.1186/s12871-019-0803-x
N.B. These documents automatically identified may not have been verified by the study sponsor.