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A study of indicators of heart and circulation injury in adult patients undergoing major abdominal surgery.

OPtimisation of Perioperative Cardiovascular Management to Improve Surgical outcomE II trial (Optimise II) - biomarker sub-study for Australian sites

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618001320246
Enrollment
103
Registered
2018-08-06
Start date
2019-01-11
Completion date
2022-09-07
Last updated
2024-07-29

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

Conditions

None listed

Brief summary

The OPtimisation of Perioperative Cardiovascular Management to Improve Surgical outcomE II trial (Optimise II) is a large multi-centre randomised trial, which seeks to establish whether increasing blood flow from the heart during major abdominal surgery reduces the risk of infection. Within this large study, blood samples from 200 patients will be collected. All samples will be analysed for evidence of heart injury and 50 samples will be analysed also for circulation injury. This blood sample analysis will try to identify patients who are at higher risk of complications after surgery.

Interventions

The OPtimisation of Perioperative Cardiovascular Management to Improve Surgical outcomE II trial (Optimise II) is large multi-centre randomised trial, which seeks to establish whether targeted fluid optimisation with minimally invasive cardiac output monitoring and a low dose inotrope infusion can improve outcomes in patients having elective gastrointestinal surgery. In the intervention group of OPTIMISE II, a haemodynamic protocol will start at the induction of surgery and continue until 4 ho

The OPtimisation of Perioperative Cardiovascular Management to Improve Surgical outcomE II trial (Optimise II) is large multi-centre randomised trial, which seeks to establish whether targeted fluid optimisation with minimally invasive cardiac output monitoring and a low dose inotrope infusion can improve outcomes in patients having elective gastrointestinal surgery. In the intervention group of OPTIMISE II, a haemodynamic protocol will start at the induction of surgery and continue until 4 hours after surgery. Cardiac output and stroke volume will be measured by cardiac output monitor, Edwards Lifesciences Flotrac(TM) or Clearsight (TM). In addition to the maintenance fluid and blood products, patients will receive 250ml fluid challenges with a recommended solution as required in order to achieve a maximal value of stroke volume. The absence of fluid responsiveness will be defined as the absence of a sustained rise in stroke volume of at least 10% for 20 minutes or more. In addition, patients will receive a low dose inotrope infusion at a fixed rate which will be commenced after fluid replacement has been initiated. The choice of inotrope will be made at the discretion of the local investigator, according to local preference and availability. The options are dobutamine at a dose/rate of 2.5 µg/kg/min and dopexamine at an equipotent dose/rate of 0.5 µg/kg/min. In this sub-study, we will collect biomarkers in order to identify any differences in cardiac injury (Troponin) and endothelial injury between the two comparator groups in Optimise II, cardiac output-guided haemodynamic therapy with an inotrope versus "usual care" without the use of cardiac output monitoring. The biomarkers will be collected over 48hrs from the beginning of surgery until day 2 post surgery.

Sponsors

St Vincent's Hospital Melbourne
Lead SponsorHospital

Eligibility

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

Inclusion criteria

Patients who have consented and recruited to the OptimiseII trial which includes patients aged 65 years and over undergoing major elective surgery involving the gastrointestinal tract that is expected to take longer than 90 minutes.

Exclusion criteria

• Inability or refusal to provide patient consent • clinician refusal (including intention to monitor cardiac output from the start of surgery regardless of study group allocation) • American Society of Anesthesiologists (ASA) score of I • patients expected to die within 30 days • acute myocardial ischaemia within 30 days prior to randomisation • acute pulmonary oedema within 30 days prior to randomisation • contra-indication to low-dose inotropic medication • pregnancy at time of enrolment • current participation in another clinical trial of a treatment with a similar biological mechanism or primary outcome measure

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026