Comparing early vasopressor treatment methods for sepsis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate two different approaches for treating sepsis in the early phase after hospital admission. One method involves administering intravenous fluids first, followed by a vasopressor medication called norepinephrine if needed, while the alternative method starts with norepinephrine and adds fluids as necessary. The study will assess which approach leads to better recovery outcomes and fewer complications for patients suffering from sepsis. The trial is designed to provide insights into optimizing treatment protocols for this life-threatening condition.

Why it matters

Who can join: the full rules

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 (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

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

Where it's running

• Aintree University Hospital
  Aintree, United Kingdom Recruiting
• Fairfield General Hospital
  Bury, United Kingdom Recruiting
• Addenbrookes Hospital, Cambridge
  Cambridge, United Kingdom Recruiting
• Royal Derby Hospital
  Derby, United Kingdom Recruiting
• Royal Infirmary of Edinburgh
  Edinburgh, United Kingdom Recruiting
• Victoria Hospital
  Fife Keith, United Kingdom Recruiting

Study contacts

• Study coordinator: Hannah Greenwood
• Email: Hannah.Greenwood@nhs.scot
• Phone: 0141 314 4366

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Non-invasive hemodynamic guidance for sepsis care on medical wards

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.