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TITLE

Early Vasopressors in Sepsis

Age ≥ 18 years Sepsis Vasopressors

Study aim

The aim of this research study is to compare two treatments (fluid and blood pressure medication via a drip) for patients in hospital with sepsis

Inclusion Criteria

  • Age ≥ 18 years
  • Clinically suspected or proven infection resulting in principal reason for acute illness
  • SBP < 90 mmHg or MAP of < 65 mmHg
  • Measured serum lactate of >2 mmol/L at the time of eligibility assessment (Nb 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

Exclusion Criteria

  • >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

  • Nb. Please note that the patients vital signs and intake of intravenous fluids may fluctuate. However, it is those vital signs and intravenous fluids reviewed at the time of eligibility that determine entry into the trial.

Enrollment conflicts

  • Co-enrolment to an observational study is permitted but not to another clinical trial of a medicinal product (CTIMP); ie any other drug trial

Step-by-step recruitment guide

Standard working hours (09:00 – 17:00)
1 Contact the ED Research Team when an eligible patient arrives in the ED — send a message via Epic chat to "ED Research Team" or phone 217907.
2 The ED Research Team will see the patient to arrange consent and randomisation.
Out of hours & weekends
X The trial is currently only recruiting within the working hours of the research Team

Further information