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Comparing a Conservative Fluid Management Strategy to Usual Care in Participants after Cardiac Surgery

A Multi-centre, Open Label, Randomised Controlled Trial to Compare a Conservative Fluid Management Strategy to Usual Care in Participants after Cardiac Surgery

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001301459
Acronym
The FAB study
Enrollment
700
Registered
2016-09-16
Start date
2016-11-28
Completion date
2019-01-04
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

Cardiovascular disease is the leading cause of death in New Zealand and a significant burden on the health system economically and socially. High cancellation rates for cardiac surgery are a significant issue in New Zealand due to lack of access to Intensive Care Unit (ICU) beds. This is an NZ health delivery issue and major concern for participants, clinicians and policy makers. Cardiac surgical participants are frequently treated with fluid in the ICU to prevent development of organ dysfunction. However fluid administration may also have deleterious effects including an increased risk of morbidity and mortality. We have demonstrated previously that a strategy designed to avoid unnecessary fluid administration significantly reduces fluid loading and ICU length of stay. This randomised controlled trial aims to determine if a protocolised strategy avoiding unnecessary fluid administration reduces ICU length of stay, overcoming a major bottleneck to effective delivery of cardiac surgery in NZ, and improves participant-centred outcomes.

Interventions

A protocol guided strategy for administering bolus fluid utilising stroke volume variation to limit fluid administration to those likely to be fluid responsive. Once the patient returns to the ICU following cardiac surgery, bedside staff - nursing and medical - will utilise a protocol to guide fluid administration. If the clinician suspects the patient to have a known or suspected inadequate cardiac output (i.e. the cardiac index is < 2.5L/min/m2; poor perfusion;poor urine output) and the strok

A protocol guided strategy for administering bolus fluid utilising stroke volume variation to limit fluid administration to those likely to be fluid responsive. Once the patient returns to the ICU following cardiac surgery, bedside staff - nursing and medical - will utilise a protocol to guide fluid administration. If the clinician suspects the patient to have a known or suspected inadequate cardiac output (i.e. the cardiac index is < 2.5L/min/m2; poor perfusion;poor urine output) and the stroke volume variation (SVV) is >13 then they will be instructed to administer a fluid bolus of 250mls of crystalloid or colloid as determined by the treating clinician. If the SVV is <13 then the treating clinician should consider using vasopressors to maintain or improve cardiac output. Type of vasopressor and dose will be determined by the treating clinician. The protocol will continue until the patient is desedated and extubated or they reach 24 hours post-operative if still mechanically ventilated. Deviations from the protocol will be collected by the research nurses at each site.

Sponsors

Rachael Parke
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Adult participants 16 years or older 2. Having elective cardiac surgery with cardiopulmonary bypass 3. Preoperative EUROSCORE II of 0.9 or greater

Exclusion criteria

1. Emergency procedure 2. Contraindication to FloTrac monitoring such as Atrial fibrillation; IABP in situ or anticipated; Open chest; 3. Critical post-operative condition or Participant not expected to survive for more than 24 hours or Open chest 4. ECMO or Ventricular assist device in situ or anticipated 5. Indication for specific fluid management post-operatively such as Adult congenital heart surgery or End stage renal failure requiring dialysis 6. Enrolment not considered to be in the participant's best interest

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026