None listed
Conditions
Brief summary
Preliminary in vitro data suggests that afterload reduction is independently associated with a reduction in LV filling pressure, with a reduction in mean arterial pressure of 12.5mmHg associated with a 5mmHg reduction in LV filling pressure (Jiang et al; data presented at ISHLT conference, 2023). The aim of this study is to quantify this relationship in humans. This data will allow better optimisation of blood pressure management in VA-ECMO patients, and appropriate selection of those patients who require more invasive and costly techniques to achieve LV unloading. The primary objective of this study is to quantify the extent to which reduction in mean arterial pressure affects left ventricular filling pressure during VA-ECMO support. The study is a single-arm trial with haemodynamic and echocardiographic endpoints. Patients on VA-ECMO who are undergoing a clinically indicated cardiac catheterisation procedure will be administered sodium nitroprusside as a continuous infusion, to achieve a reduction in MAP of 20mmHg but not below 60mmHg. LV end-diastolic pressure will be measured at baseline and at maximal infusion dose. The infusion will then be ceased.
Interventions
Administration of sodium nitroprusside infusion to achieve a reduction in mean arterial pressure of at least 20mmHg, or a minimum mean arterial pressure of 60mmHg (whichever is higher). The medication will be administered as a once only, intravenous infusion. Mean arterial pressure will be monitored using a peripheral arterial cannula or the arterial access sheath.
Initial rate of infusion: 20 micrograms/minute
Uptitration of infusion rate by 20 micrograms/minute every 3 minutes until any of th
Administration of sodium nitroprusside infusion to achieve a reduction in mean arterial pressure of at least 20mmHg, or a minimum mean arterial pressure of 60mmHg (whichever is higher). The medication will be administered as a once only, intravenous infusion. Mean arterial pressure will be monitored using a peripheral arterial cannula or the arterial access sheath. Initial rate of infusion: 20 micrograms/minute Uptitration of infusion rate by 20 micrograms/minute every 3 minutes until any of the following occur, at which point the infusion will be stopped: 1) The target reduction in mean arterial pressure (20mmHg) is reached, OR 2) The minimum allowed mean arterial pressure (60mmHg) is reached, OR 3) The patient experiences an adverse drug reaction, OR 4) The maximum allowed infusion rate is achieved (200micrograms/min)
Sponsors
Sydney Local Health District
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants will be eligible for this study if all of the following criteria are met: • Adult (greater than or equal to 18 years old) • Currently on VA-ECMO or planned to commence VA-ECMO • Planned to undergo a procedure in the cardiac catheterisation laboratory (eg diagnostic angiography or percutaneous coronary intervention) whilst on VA-ECMO
Exclusion criteria
Participants will be ineligible for the study if any of the following criteria are met: • Persons <18 years old • Patient or next of kin is unable to provide consent • Patients who have been transferred to the cardiac catheterisation laboratory whilst undergoing extracorporeal cardiopulmonary resuscitation (ECPR)
Outcome results
None listed