Co-enrolment to an observational study is permitted but not to another clinical trial of a medicinal product
(CTIMP); ie any other drug trial
Therefore, can't be co-enrolled with CRASH-4
Inclusion Criteria: All of:
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.
If the patient is eligible:
Explain that the patient may be eligible for the EVIS study.
Gain verbal agreement in principle before proceeding further. Explain:
Taking part in research is likely to improve the quality of their care
Risks are carefully controlled - research is safe
Explain the uncertainty that exists with respect to treatment of their condition;
If they change their mind they can withdraw their participation at any point
Step by Step Guide to Recruitment:
For eligible patients
please contact ED Research Team via EPIC Chat and refer the patient to them. The research team will do the rest retrospectively :
Send the ED Research Team a message via Epic chat "ED research Team" or phone 217907
Out of hours and weekends:
The trial is currently only recruiting within the working hours of the research Team