Early Vasopressors in Sepsis

Recruiting now · Phase 3

Conditions studied: Sepsis

In brief

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.

Key facts

Study ID

NCT05179499

Run by

NHS Greater Glasgow and Clyde

People needed

1006

Starts

2022-10-11

Expected to finish

2027-10-01

Last updated by the study team

2026-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Hospital presentation within last 12 hours

You may not qualify if…

• >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
• 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
• Pregnancy. All women of childbearing potential (WoCBP) must have a negative urine or serum pregnancy test result completed as part of screening requirements.
• WoCBP are defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
• Other primary causes of shock (e.g. suspected cardiogenic shock, haemorrhagic shock, etc)
• History or evidence of any other medical, neurological or psychological condition that would expose the subject to an undue risk of a significant Adverse Effect as determined by the clinical judgement of the investigator
• Participation in other clinical trials of investigational medicinal products

Where it is running

• Salford Royal — Salford, United Kingdom (enrolling)
• Peterborough City Hospital — Peterborough, United Kingdom (enrolling)
• Royal Berkshire Hospital — Reading, United Kingdom (enrolling)
• Queens Hospital Barking — Romford, United Kingdom (enrolling)
• Aintree University Hospital — Aintree, United Kingdom (enrolling)
• Fairfield General Hospital — Bury, United Kingdom (enrolling)
• Addenbrookes Hospital, Cambridge — Cambridge, United Kingdom (enrolling)
• Royal Derby Hospital — Derby, United Kingdom (enrolling)
• Royal Infirmary of Edinburgh — Edinburgh, United Kingdom (enrolling)
• Victoria Hospital — Fife Keith, United Kingdom (enrolling)
• Glasgow Royal Infirmary — Glasgow, United Kingdom (enrolling)
• Queen Elizabeth University Hospital — Glasgow, United Kingdom (enrolling)
• Hull Royal Infirmary — Hull, United Kingdom (enrolling)
• Kettering General — Kettering, United Kingdom (enrolling)
• University Hospital Monklands — Lanark, United Kingdom (enrolling)
• Royal Liverpool University Hospital — Liverpool, United Kingdom (enrolling)
• Newham University Hospital — London, United Kingdom (enrolling)
• Royal London Hospital — London, United Kingdom (enrolling)
• University Hospital Lewisham — London, United Kingdom (enrolling)
• John Radcliffe Hospital — Oxford, United Kingdom (enrolling)
• Royal Alexandra Hospital — Paisley, United Kingdom (enrolling)
• Royal Blackburn Hospital — Blackburn, United Kingdom
• University Hospital Crosshouse — Kilmarnock, United Kingdom
• St George's — London, United Kingdom
• Leicester Royal Infirmary — Leicester, United Kingdom

Full record on ClinicalTrials.gov

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