None listed
Conditions
Brief summary
Open heart surgery saves thousands of lives each year in Australia, but often injures the kidney. Kidney oxygen deficiency is a major cause of kidney injury. We propose a new way to prevent acute kidney injury by increasing kidney oxygen levels during heart surgery. The aim of this trial is to determine whether this new approach to prevention of kidney injury is safe, feasible and effective.
Interventions
Patients undergoing cardiac surgery requiring cardiopulmonary bypass will be randomised to either usual care or a 20-25% greater pump flow (up to a maximum of 3.0 L/min per square metre of body surface area) at a target mean arterial pressure of at least 80 mmHg. The pump flow employed during surgery is controlled by the attending clinical perfusionist. The duration of cardiopulmonary bypass for each patient will depend on the nature of their surgical procedure but will usually range from 60 min
Patients undergoing cardiac surgery requiring cardiopulmonary bypass will be randomised to either usual care or a 20-25% greater pump flow (up to a maximum of 3.0 L/min per square metre of body surface area) at a target mean arterial pressure of at least 80 mmHg. The pump flow employed during surgery is controlled by the attending clinical perfusionist. The duration of cardiopulmonary bypass for each patient will depend on the nature of their surgical procedure but will usually range from 60 min to 120 min. Fidelity of the intervention will be assessed by the researcher in the operating theatre who will record pump flow and arterial pressure at 5 min intervals, and/or by analysis of the electronic records generated by the heart lung machine.
Sponsors
Monash Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key inclusion criteria: (1) Non-emergency cardiac surgery on CPB (coronary artery bypass graft and/or valve surgery) at Monash Health, (2) An expected duration of CPB of 90 minutes or more.
Exclusion criteria
(1) An expected duration of CPB of less than 90 minutes, (2) An expected nadir core body temperature during CPB of <32 °C (rare for this type of surgery), (3) Pre-existing AKI as defined by the KDIGO criteria, (4) Severe chronic kidney disease (serum creatinine >265 µmol/L), (5) Need for haemodialysis, (6) Prior renal transplantation, (7) A pre-operative state that precludes informed consent.
Outcome results
None listed