A Pilot, Randomised, Blinded, Feasibility, Safety and Biochemical and Physiological Efficacy Study of Terlipressin versus Placebo in Hypotensive Sepsis

The management of patients who have serious infection and a low blood pressure is complex and includes making sure that the circulation is stable, safe and optimal in terms of blood flow to vital organs. This is called resuscitation. The best way to deliver resuscitation is uncertain. However, it typically includes the use of fluids given though a vein and drugs to help increase blood pressure. Drugs to increase blood pressure can be useful but those available either have a short duration of action (minutes) or can only be given though a large vein. As the need for drugs to increase blood pressure can last for hours or even days, this means that a special catheter needs to be inserted for such treatment into a large central vein like the jugular (neck) vein. This carries risks, requires special expertise and takes time. Thus, potentially helpful treatment is often delayed. As a consequence, blood pressure may remain undesirably low for more than an hour and/or the patient may be given large amounts of fluids instead, which can be undesirable. More recently, however, a medication called terlipressin has been developed to help liver patients with low blood pressure and worsening kidney function. Terlipressin can be given as a single dose injection 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 serious infection. 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 patients with infection. In this study we aim to test whether, in patients with infection and low blood pressure, terlipressin is more effective than placebo (dummy injection) at restoring blood pressure and whether such treatment changes the amount of fluid given and kidney function.