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Comparing early vasopressor treatment methods for sepsis

Early Vasopressors in Sepsis

Phase 3 Interventional NHS Greater Glasgow and Clyde · NCT05179499

This study is testing two different ways to treat sepsis in the hospital to see which one helps patients recover better and have fewer complications.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1006 (estimated)
Ages18 Years and up
SexAll
SponsorNHS Greater Glasgow and Clyde Academic / other
Locations25 sites (Aintree and 24 other locations)
Trial IDNCT05179499 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old who present with suspected or confirmed infections and exhibit low blood pressure or elevated serum lactate levels.

Not a fit: Patients who have received more than 1500ml of intravenous fluid prior to screening or require immediate surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved recovery times and reduced complications for patients with sepsis.

How similar studies have performed: Other studies have explored various resuscitation strategies in sepsis, but the specific approach of early continuous peripheral vasopressor infusion is less commonly tested, making this study a potentially novel contribution.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Aintree and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions SepsisResuscitationNorepinephrineIntravenous fluidsEmergency MedicineCritical Care
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.