None listed
Conditions
Brief summary
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.
Interventions
The study will recruit patients in the Emergency Department (ED), in the Intensive care unit (ICU) and in the wards after a Medical Emergency Team (MET) review. Eligible patients will be randomised to receive either:
- Terlipressin at 0.85 mg IV push, OR
- Placebo (Normal Saline 0.9%)
The study treatments will be macroscopically identical and will be supplied in identical 5 ml syringes prepared by ICU research.
The initial treatment dose will be 0.425 mg (half dose). If haemodynamic goals ar
The study will recruit patients in the Emergency Department (ED), in the Intensive care unit (ICU) and in the wards after a Medical Emergency Team (MET) review. Eligible patients will be randomised to receive either: - Terlipressin at 0.85 mg IV push, OR - Placebo (Normal Saline 0.9%) The study treatments will be macroscopically identical and will be supplied in identical 5 ml syringes prepared by ICU research. The initial treatment dose will be 0.425 mg (half dose). If haemodynamic goals are achieved after one hour the participant will only receive the study drug at half dose. However, if the haemodynamic goals are not met after one hour the remaining half dose will be administered and the participant will receive the full-dose (0.85 mg) of the study drug. In all instances treatment will be given every six hours until resolution of hypotension or to a maximum of 24 hours using the individualised patient-responsive dose.
Sponsors
Anaesthesia Intensive Care Trust Fund
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Patients aged 18 years or older - Confirmed or suspected sepsis presentation to the emergency department (ED) or activation of an urgent medical emergency team review or admission to the intensive care unit Hypotension
Exclusion criteria
- Pregnancy - Death is considered imminent (within 24 hours) - Known contraindications to terlipressin such as: severe peripheral vascular disease, Raynaud's phenomenon, Known allergy to terlipressin, Unstable angina, Recent myocardial infarction, Asthma.
Outcome results
None listed