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Feasibility of randomization to different flow targets for cardiopulmonary bypass.

Feasibility of randomization to different flow targets for cardiopulmonary bypass in patients undergoing cardiac surgery

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000467437
Enrollment
50
Registered
2025-05-16
Start date
2026-06-01
Completion date
2028-04-01
Last updated
2026-06-01

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

Conditions

None listed

Brief summary

Worsening kidney function is common after cardiac surgery. During cardiac surgery, cardiopulmonary bypass (CPB) is commonly utilised to deliver blood around the body However, the use of CPB is known to decrease blood flow to the kidneys compared to normal, putting the kidneys at risk of harm. Increasing overall CPB blood flow to the whole body has minimised kidney harm in small studies. However, the benefit of routinely increased CPB blood flow has not been tested in real-world settings. In order to work towards a large trial that applies high CPB blood flow routinely, we aim to demonstrate the feasibility of targeting different CPB blood flow targets in two different hospitals. Adult non-female patients having cardiac surgery who: require normal temperatures to manage their surgery; have normal oxygen-carrying capacity and without severe kidney disease will randomly receive blood flows at the highest range of acceptable CPB flow or blood flows at the middle of that range. Afterwards, routinely collected data related to kidney outcomes and other outcomes will be collected. An extra blood test will be collected comparing red cell breakdown in both groups. This trial is expected to demonstrate feasibility for a larger trial.

Interventions

Targeted cardiouplmonary bypass flows of 2.8 L/min/m^2 of Body surface area for the entire duration of cardiopulmonary bypass for cardiac surgery, which may vary from less than 45 minutes to more than 180 minutes, depending on surgical complexity. This will be performed by the perfusionist running the cardiopulmonary bypass machine. Adherence will be assessed as part of the primary outcome through interrogation of the bypass machine records.

Sponsors

Raymond Hu, Austin Health
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

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

Inclusion criteria

>18 years of age - Undergoing cardiac surgery involving cardiopuplmonary bypass - Planned temperature >32°C during cardioplmonary bypass - Estimated glomerular filtration rate (eGFR) >30ml/min/1.73m^2 of body surface area (BSA) - Lowest anticipated indexed systemic delivery of oxygen (DO2i) of >280 ml/L/m2 of BSA (based on weight, pre-op haemoglobin and 1500mL prime volume) - Able to consent for participation

Exclusion criteria

- Pregnancy - Failure to meet any inclusion criteria

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 11, 2026