Early Vasopressors in Sepsis

• Status: Not yet recruiting
• Trial end date: 2025-07-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: Guy's and St Thomas' NHS Foundation Trust; Imperial College London; Salford Royal NHS Foundation Trust; St George's, University of London; University of Edinburgh; University of Glasgow
• Treatments: Norepinephrine

Criteria

Inclusion Criteria:

• Age >18 years

• Clinically suspected or proven infection resulting in principal reason for acute illness

• SBP <90mmHg or MAP <65mmHg and measured serum lactate of >2mmol/L at the time of eligibility assessment

• Hospital presentation within last 12 hours

Exclusion Criteria:

• >1500ml of intravenous fluid prior to screening

• Clinically judged to require immediate surgery (within one hour of eligibility

• assessment);

• Immediate (< 1hour) requirement for central venous access

• Chronic renal replacement therapy

• Known allergy/adverse reaction to norepinephrine

• Palliation / end of life care (explicit decision by patient/family/carer in conjunction with clinical team that active treatment beyond symptomatic relief is not appropriate)

• Previous recruitment in the trial

• Patients with permanent incapacity