Early Vasopressors in Sepsis

Summary

Sepsis is a life-threatening reaction to an infection. It happens when the immune system overreacts to an infection and starts to damage the body's tissues and organs.

The aim of this research study is to compare the two different ways to treat sepsis, in the early phase of treatment immediately after the participants arrive in hospital. The standard approach is to give a salt solution fluid through a drip in the participants arm to start with, then adding in a medication that increases the blood flow to the participants vital organs (a vasopressor mediation called norepinephrine) if required. The alternative approach is to start the vasopressor medication immediately, and then add in extra salt solution fluid via a drip if required. Vasopressors work by increasing the blood pressure which allows a better blood flow to the internal organs. The investigators plan to see which approach is better and to see if they have a role in improving a patient's recovery time, reducing complications, the length of time they stay in hospital and longer term poor health.

Based on research that has already been done, the investigators believe treating patients with vasopressors when they arrive in the Emergency Department, may have potential advantages over the standard fluids used today. However, the evidence is not clear and that is why this research is being done.

Conditions

• Sepsis

Interventions

DRUG

Norepinephrine

Norepinepherine should be prepared and delivered at a concentration of 16 micrograms/ml

OTHER

Balanced Crystalloid

IV fluids administered as per standard care

Sponsors & Collaborators

• University of Edinburgh

  collaborator OTHER

• Northern Care Alliance NHS Foundation Trust

  collaborator OTHER

• University of Manchester

  collaborator OTHER

• University of Glasgow

  collaborator OTHER

• NHS Lothian

  collaborator OTHER_GOV

• Chelsea and Westminster NHS Foundation Trust

  collaborator OTHER

• NHS Greater Glasgow and Clyde

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-11

Primary Completion

2026-11-30

Completion

2027-10-31

Countries

• United Kingdom

Study Locations