Goal-directed Therap for Patients Undergoing Major Liver Resection

A Prospective Multicentre Randomized Controlled Trial of Standard Compared to Surgery Specific Goal-directed Therapy (GDT) for Patients Undergoing Major Liver Resection

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000172404

Acronym

Not applicable

Enrollment

Registered

2016-02-11

Start date

2013-09-09

Completion date

2016-05-23

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to evaluate if patients undergoing major liver resection managed by intraoperative goal directed therapy with the Flotrac/Vigileo deviceTM will have a shorter length of hospital stay with fewer post-operative complications compared to patients managed by standard care. Who is it for? You may be eligible to join this study if you are aged 18 years or more and are scheduled to undergo major liver resection. Study details: Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will have their haemodynamic variables (fluid dynamic and blood flow) be managed by intraoperative goal directed therapy (GDT) using the Flotrac/Vigileo deviceTM (FloTrac/Vigileo Version 3.02, Edwards Lifesciences, Irvine, CA, USA). This minimally invasive device automatically calculates key flow parameters every 20 seconds and recognizes and allows for adjustments in haemodynamic variables in patients undergoing major surgery. Importantly, it enables the anaesthetist to make a differential diagnosis leading to either a volume or cardiovascular intervention (preload, afterload and contractility), by providing continuous information on the patients cardiac output, stroke volume, and systemic vascular resistance. Participants allocated to the control group will have fluid management and inotropic use guided by the routine cardiovascular monitoring in place i.e. arterial line, and central venous catheter, which will be at the discretion of the anaesthetist, who will be blinded to Flotrac data. The Control group anaesthetist will be allowed to have the Flotrac haemodynamic data unblinded if needed for clinical decision making but patients will be removed from analysis if this occurs. There is now compelling evidence that fluid optimization and GDT in patients undergoing colorectal surgery leads to better outcomes, particularly in high risk patients. This study will contribute to understanding if similar benefit of GDT is also observed in patients undergoing major liver resection.

Interventions

Goal-directed Therapy/Experimental Group Patients undergoing Liver Resection in the Goal Directed Therapy (GDT) group (experimental group) will have a Flotrac/Vigileo device TradeMark connected after insertion of the arterial line. The arterial catheters will be connected to the cardiac output device transducer system and haemodynamic data from the Flotrac device will be collected throughout surgery. All transducers will be zeroed to atmospheric pressure at the level of the right atrium. Patients in the GDT group will be managed by a Stroke Ventricular Volume (SVV) guided protocol to maintain SVV < 20%. This percentage of SVV is frequently used in our institution as a target for patients undergoing this procedure. For the GDT group, if SVV remains above 20% for at least 2 min, then a 250mL bolus of balanced crystalloid (Hartmanns solution or Plasmalyte) or colloid fluid (Albumen) will be given. The SVV will be assessed every 20 seconds via the FloTrac/Vigileo proprietary algorithm. Similar to other GDT studies, the preferred colloid will be albumin secondary to the known effects of improved intravascular repletion and intravascular half life and the theoretical benefit of prolonged stroke volume optimization. In both groups, the administration of blood products will be at the discretion of the anaesthetist, as clinically indicated. There will be no standard protocol for fluid maintenance infusion for either group. The GDT group will receive standard perioperative Enhanced Recovery After Surgery (ERAS) care and additional haemodynamic monitoring using the FloTrac/Vigileo TradeMark (Edwards Lifesciences, Irvine, CA). The anaesthetist will have no influence over any aspect of postoperative care management. All clinicians and nursing staff in charge of postoperative care will be blinded to the allocation of patients. The Flotrac system will be connected to the patient prior to surgical incision and discontinued as soon as the surgery is complete.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Investigator)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

All patients (age > 18 years) undergoing liver resection

Exclusion criteria

1. Age less than 18 years 2. Abnormal pre-operative coagulopathy: INR (international normalised ratio) > 1.5, platelet count < 75 x 109/l 3. Severe hepatic insufficiency (bilirubin > 30umol/L, ALP (alkaline phosphatase) >300iu/L, ALT (alanine transaminase) > 50iu/L, albumin < 25g/dL, INR > 1.5) 4. Severe renal impairment: Serum Creatinine >250ummol/L 5. American Society of Anaesthesiologists (ASA) physical status IV or V

Outcome results