None listed
Conditions
Brief summary
Vasoplegia is a state of circulatory shock that is a common complication after orthotopic heart transplantation, and increases the risk of prolonged ICU and hospital stay, increases the risk of acute kidney injury, and carries a higher risk of requiring dialysis long-term. It is thought to occur due to an abnormal immune response following the surgery. Currently, there are no licensed therapies to prevent or treat vasoplegia. Cytokine haemadsorption is a form of blood purification therapy, that is believed to reduce the incidence and severity of vasoplegia by removing the immune chemicals contributing to its development. Early evidence has shown improved patient outcomes from using cytokine haemadsorption intraoperatively during heart transplantation, but to date no study has evaluated whether cytokine haemadsorption used post-operatively (in addition to intraoperatively) has benefit. Given the proposed mechanisms of vasoplegia and our institutional experience indicating that it can persist for days after the surgery, we believe that using cytokine haemadsorption intraoperatively and postoperatively may further improve patient outcomes by reducing the incidence and severity of vasoplegia. We therefore propose a randomised trial of cytokine haemadsorption plus standard care vs. standard care alone in adult patients undergoing orthotopic heart transplantation.
Interventions
Intra-operative and post-operative use of cytokine haemadsorption to modulate the inflammatory response thought to be contributing to vasoplegia.
Cytokine haemadsorption is performed using an extracorporeal circuit with a specific filter in series in the circuit. Pathogenic cytokines are adsorbed from the blood by the filter.
Intra-operatively, a Cytosorb (Cytosorbents) filter will be used in series with the cardiopulmonary bypass circuit to facilitate cytokine haemadsorption. Heparin antico
Intra-operative and post-operative use of cytokine haemadsorption to modulate the inflammatory response thought to be contributing to vasoplegia. Cytokine haemadsorption is performed using an extracorporeal circuit with a specific filter in series in the circuit. Pathogenic cytokines are adsorbed from the blood by the filter. Intra-operatively, a Cytosorb (Cytosorbents) filter will be used in series with the cardiopulmonary bypass circuit to facilitate cytokine haemadsorption. Heparin anticoagulation will be used intraoperatively, with the level of anticoagulation guided by the cardiothoracic surgeon, anesthetist and perfusionist. The duration of cytokine haemadsorption will be dependent on the duration of cardiopulmonary bypass. The duration of cardiopulmonary bypass can vary significantly, for example depending on whether the patient has previously had a sternotomy, which can significantly increase bypass duration. The anticipated duration of bypass would range between 90 and 240 minutes. Post-operatively in the ICU, cytokine haemadsorption will be performed for 24 hours using an Oxiris (Baxter) filter on a Prismaflex platform. This will use citrate anticoagulation guided by institutional policy and the treating intensivist (therapeutic anticoagulation using heparin immediately postoperatively will not be feasible or safe). The default dose prescribed will be 25ml/kg/hr with no fluid removal or ultrafiltration unless an indication for fluid removal is present. If the circuit clots within the 24 hour time period, a new circuit will be created with a new Oxiris filter to ensure the full 24 hours of post-operative cytokine haemadsorption is completed. The intervention will be given in addition to standard surgical, anaesthetic and post-operative care of adult heart transplant patients. Adherence to the intervention will be checked by reviewing intraoperative and ICU medical records.
Sponsors
St Vincent's Hospital, Sydney
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
Adult patients undergoing elective OR emergency orthoptic heart transplant, with or without ventricular assist device (VAD) explant, with or without other solid organ transplant (eg. Lung, liver or kidney).
Exclusion criteria
Age <16 End-stage renal failure requiring long-term renal replacement therapy Contraindication or inability to secure vascular access for haemadsorption Allergy, anaphylaxis or contraindication to heparin (CytosorbÔ circuit requires heparin, and the OxirisÔ has heparin-bonded membrane) Contraindication to citrate anticoagulation Patients who are suspected or confirmed to be pregnant
Outcome results
None listed