A Pilot, Randomised, Blinded, Feasibility, Safety and Biochemical and Physiological Efficacy Study of Terlipressin vs. Placebo in Cardiac Surgery Patients with the Post-operative High Cardiac Output and Hypotension syndrome

The management of patients who have a high cardiac output (the amount of blood pumped by the heart every minute) and a low blood pressure after open heart surgery is complex because the best way to deliver best post-operative treatment of the circulation is uncertain. However, treatment typically includes the use of fluids given though a vein and drugs to help increase blood pressure to safer levels. Such blood pressure drugs can be useful but can have adverse effects on heart function or cause disturbances of the heart rhythm. Thus, they are often avoided and used very late in the management of these patients when blood pressure is really low. As a consequence, blood pressure may remain undesirably low for a long time and patients may be given large amounts of fluids instead, which can also be undesirable. More recently, however, a medication called terlipressin has been developed to help liver patients who have a high cardiac output with low blood pressure and worsening kidney function. Terlipressin can be given as a single shot through any hand or arm vein and can increase blood pressure for up to 6 hours. Terlipressin offers the opportunity to improve blood pressure management in patients with a high cardiac output and a low blood pressure after heart surgery without the risk of causing heart injury and rhythm disturbances. However, because terlipressin has only been used to support blood pressure in this way in liver patients, we do not know how effective it would be in such selected cardiac surgery patients. In this study we wish to test whether, in open heart surgery patients with a high cardiac output but a low blood pressure, terlipressin is more effective than placebo (dummy injection) at restoring blood pressure and whether such treatment is safe and changes the amount of fluid given and kidney function for the better.