Early Vasopressors in Sepsis

ConditionSepsis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNHS Greater Glasgow and Clyde

About this trial

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.

Eligibility criteria

Qualifiers

Age >18 years

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

SBP < 90 mmHg or MAP of < 65 mmHg (within an hour of eligibility assessment)

Measured serum lactate of > 2 mmol/L. The serum lactate should be measured 2 hours prior to determination of eligibility, where possible. Longer timeframes may be used and justified within the medical notes if, in the opinion of the investigator, the clinical status of the patient has not significantly improved in the time interval between lactate measurement and eligibility assessment. Lactate measurements more than 4 hours prior to eligibility assessment should not normally be used.

Disqualifiers

>1500ml of intravenous fluid prior to screening

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

Immediate (< 1 hour) requirement for central venous access

Chronic renal replacement therapy

Trial design

Treatments tested in this trial

  • Norepinephrine
  • Balanced Crystalloid

Treatment groups

1,006 Participants
are divided into 2 treatment groups

Sponsors and collaborators

NHS Greater Glasgow and Clyde

Lead sponsor

University of Edinburgh

Collaborator

Northern Care Alliance NHS Foundation Trust

Collaborator

University of Manchester

Collaborator

University of Glasgow

Collaborator

NHS Lothian

Collaborator

Chelsea and Westminster NHS Foundation Trust

Collaborator