ANZCTR - Registration

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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]

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

Liver surgery

Fluid management

Condition category

Condition code

Surgery

Other surgery

Anaesthesiology

Other anaesthesiology

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Metabolic and Endocrine

Other metabolic disorders

Blood

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]

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]

Duration of hospital stay in hours. Data for length of stay will collected from our hospitals electronic medical records.

Timepoint [1]

This will be calculated as number of hours beginning from surgical closure to hospital discharge.

Secondary outcome [1]

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]

Intraoperative: 30 minutes prior to induction of anaesthesia until completion of surgery (last surgical stitch).

Secondary outcome [2]

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]

Postoperative: At completion of surgery until the end of day 1 post operation.

Secondary outcome [3]

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]

Intraoperative: 30 minutes prior to induction of anaesthesia until completion of surgery (last surgical stitch).

Secondary outcome [4]

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]

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?

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

Accrual to date

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 Anaesthesia
Studley Road
Heidelberg, Victoria, 3084

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Hospital

Address

Department of Anaesthesia
Studley Road
Heidelberg, Victoria, 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Reserach Ethics Committee

Ethics committee address [1]

Austin Hospital, 145 Studley Road, Heidelberg, Victoria, 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/10/2015

Approval date [1]

26/10/2015

Ethics approval number [1]

LNR/15/321

Summary

Brief summary

Right hepatectomy involves removal of a significant amount of liver parenchymal tissue and a lot of planning is required to ensure avoiding the inherent risks of major haemorrhage and severe hypotension. Over the last two decades, there have been the development of Enhanced Recovery After Surgery (ERAS) programmes particular for liver resections, aimed at reducing overall morbidity and length of hospital stay.
.
The traditional approach at Austin health focuses on “restrictive” fluid therapy, guided by “low central venous pressure anaesthesia” during liver resections. A second approach has been developed, which uses a surgery-specific cardiac output-guided algorithm for patients undergoing complex liver resection. This algorithm has been modified from another algorithm that has been used for pancreatic surgery.

The aim of the study is to evaluate the two fluid intervention strategies and their differences in the use of intraoperative fluid, vasoactive medications, post-operative complications and hospital length of stay. This is a retrospective observational study that looked at patients undergoing major right hepatectomy with usual care or “traditional” restrictive fluid therapy & low CVP anaesthesia, compared to those who were managed with the surgery-specific cardiac output algorithm.

It is hypothesised that the surgery-specific cardiac output-guided algorithm improves length of hospital stay and reduces morbidity and post-operative complications in major right hepatectomy.

Trial website

Trial related presentations / publications

Public notes

This is a retrospective study. There is no patient participation. There the date of ethics approval date occurred after the actual date of the first participant undergoing surgery.

Contacts

Principal investigator

Name

A/Prof Laurence Weinberg

Address

Department of Anaesthesia
Austin Hospital, 145 Studley Road, Heidelberg, 3084, Victoria

Country

Australia

Phone

+61 3 9496 5000

Fax

+61 3 9459 6421

laurence.weinberg@austin.org.au

Contact person for public queries

Name

Laurence Weinberg

Address

Department of Anaesthesia
Austin Hospital, 145 Studley Road, Heidelberg, 3084, Victoria

Country

Australia

Phone

+61 3 9496 5000

Fax

+61 3 9459 6421

laurence.weinberg@austin.org.au

Contact person for scientific queries

Name

Laurence Weinberg

Address

Department of Anaesthesia
Austin Hospital, 145 Studley Road, Heidelberg, 3084, Victoria

Country

Australia

Phone

+61 3 9496 5000

Fax

+61 3 9459 6421

laurence.weinberg@austin.org.au

Data sharing statement

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

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

Source	Title	Year of Publication	DOI
Embase	Impact of a goal directed fluid therapy algorithm on postoperative morbidity in patients undergoing open right hepatectomy: A single centre retrospective observational study.	2019	https://dx.doi.org/10.1186/s12871-019-0803-x

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically