RecruitingPHASE3INTERVENTIONAL

Early Vasopressors in Sepsis

This research is looking at better ways to treat adult patients with sepsis, a serious condition where the body overreacts to an infection. When you have sepsis, your blood pressure can drop which stops blood flowing properly to your organs. This study compares two approaches right after patients arrive at the hospital. One way is to first give a salty fluid (like a drip), and then use a medicine called norepinephrine if needed, which boosts blood pressure. The other way is to give norepinephrine straight away, and then add salty fluid if needed. The aim is to find out which treatment helps patients recover faster, stay in hospital for less time, and have fewer long-term health problems.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

NHS Greater Glasgow and Clyde

Enrolment target

1,006

Start

11 Oct 2022

Estimated completion

01 Oct 2027

Sepsis

What is this study about?

When someone has a severe infection, their body can sometimes overreact, leading to a life-threatening condition called sepsis. This reaction can damage the body's own tissues and organs. A key problem with sepsis is that blood pressure can drop too low, meaning vital organs don't get enough blood flow, which can be very serious.

Currently, the usual approach is to first give patients a 'salty fluid' through a drip in their arm. If their blood pressure is still too low, doctors then add a special medicine called a 'vasopressor' (like norepinephrine) which helps to increase blood pressure and improve blood flow to organs. This study is comparing that standard approach with a new idea: giving the vasopressor medicine right at the start, as soon as the patient arrives, and then adding the salty fluid if needed.

The main goal of this research is to see if starting the vasopressor medicine earlier could help patients in several ways. We want to find out if it leads to a quicker recovery, fewer complications, a shorter stay in hospital, and better long-term health. Previous research has suggested that starting vasopressors early might be helpful, but we don't have enough clear evidence yet, which is why this study is so important.

Key takeaways

Sepsis is a serious condition caused by the body's reaction to an infection.
The study compares two ways of giving initial treatment for sepsis: fluid first, or blood pressure medicine first.
The goal is to find out which treatment helps patients recover better and quicker.
Both treatment types are standard care for sepsis.
Participating is voluntary and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) who has been diagnosed with a severe infection (sepsis) that has caused your blood pressure to drop. This drop in blood pressure means your body isn't getting enough oxygen.

You wouldn't be able to join if you've already had a lot of fluid given to you through a drip before being assessed for the study, or if you need urgent surgery within the hour. Also, you can't take part if you're already on long-term kidney dialysis, have a known allergy to the study medication (norepinephrine), or if you or your family have decided not to pursue active treatment.

Other reasons you might not be able to join include if you need a special type of drip (central line) very quickly, if you're pregnant (for women, a pregnancy test is needed), or if your low blood pressure is due to other problems like a heart attack or severe bleeding and not just sepsis.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a severe infection (sepsis) causing low blood pressure?
Are you NOT currently on long-term kidney dialysis?
Are you NOT pregnant (if you are a woman of childbearing age)?
Do you NOT have an allergy to the study medication (norepinephrine)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive one of the two treatment approaches described. Doctors will closely monitor your condition and give you either the salty fluid or the blood pressure medicine first, depending on which group you are in. All patients in the study will receive medical care that is considered appropriate for sepsis. The medical team will regularly check how you're responding to treatment, including your blood pressure, and how well your organs are working. There will be no extra visits specifically for the study. Your hospital stay and follow-up care for your sepsis will be the same as patients not in the study. The total duration of your participation would cover your hospital stay and any necessary follow-up related to your sepsis treatment.

Potential risks and benefits

By taking part, you might benefit from receiving a treatment approach that could potentially improve your recovery from sepsis, reduce your time in hospital, or lead to fewer long-term health issues, though we don't know for sure which approach is best yet. As with all medical treatments, there are potential risks, but both approaches are standard care for sepsis and doctors will monitor you closely for any side effects. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (25)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Aintree University Hospital
Verified postcode
Aintree, United Kingdom· Recruiting
Royal Blackburn Hospital
Verified postcode
Blackburn, United Kingdom· Terminated
Fairfield General Hospital
Verified postcode
Bury, United Kingdom· Recruiting
Addenbrookes Hospital, Cambridge
Verified postcode
Cambridge, United Kingdom· Recruiting
Royal Derby Hospital
Verified postcode
Derby, United Kingdom· Recruiting
Royal Infirmary of Edinburgh
Verified postcode
Edinburgh, United Kingdom· Recruiting
Victoria Hospital
Verified postcode
Fife Keith, United Kingdom· Recruiting
Glasgow Royal Infirmary
Verified postcode
Glasgow, United Kingdom· Recruiting
Queen Elizabeth University Hospital
Verified postcode
Glasgow, United Kingdom· Recruiting
Hull Royal Infirmary
Verified postcode
Hull, United Kingdom· Recruiting
Kettering General
Verified postcode
Kettering, United Kingdom· Recruiting
University Hospital Crosshouse
Verified postcode
Kilmarnock, United Kingdom· Terminated

Common questions

What is sepsis?

Sepsis is a very serious condition where your body’s reaction to an infection damages its own organs and tissues. It can cause your blood pressure to drop dangerously low.

What is norepinephrine?

Norepinephrine is a medicine (often called a vasopressor) that helps to increase your blood pressure, which improves blood flow to important organs when it's too low.

Are both treatments currently used?

Yes, both salty fluid drips and norepinephrine are standard treatments for sepsis, but this study looks at the order in which they are given.

Will I know which treatment I'm getting?

Because this is a research study, you might not know immediately which specific order of treatment you're receiving at the very beginning, as this helps to ensure fair comparison between the two approaches.

Can I leave the study at any time?

Yes, you are completely free to withdraw from the study at any point, and your medical care will not be affected.

How to find out more

Hannah Greenwood

hannah.greenwood@nhs.scot 0141 314 4366 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.