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Could early Blood-Pressure drugs be a Game-Changer for sepsis?

NCT ID NCT05179499

Disease control Sponsor: NHS Greater Glasgow and Clyde Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

Sepsis is a life-threatening reaction to infection where the immune system damages the body's own tissues. This phase 3 trial compares two early treatment approaches in the emergency department: giving fluids first then a blood-pressure-raising drug (norepinephrine) if needed, versus starting the drug immediately and adding fluids as needed. The study will enroll about 1,000 adults with septic shock to see which method leads to more days alive and out of the hospital within 90 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
norepinephrine
What this could lead to
If this approach works, it could lead to faster recovery and fewer complications for sepsis patients by starting blood-pressure support earlier.
What could go wrong
This is a large trial, but the benefit of early vasopressors is still unproven. There is a risk that early use may cause side effects or not improve outcomes compared to standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,006 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

infectious disease with sepsis Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sepsis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Addenbrookes Hospital, Cambridge

    RECRUITING

    Cambridge, United Kingdom

  • Aintree University Hospital

    RECRUITING

    Aintree, United Kingdom

  • Fairfield General Hospital

    RECRUITING

    Bury, United Kingdom

  • Glasgow Royal Infirmary

    RECRUITING

    Glasgow, United Kingdom

  • Hull Royal Infirmary

    RECRUITING

    Hull, United Kingdom

  • John Radcliffe Hospital

    RECRUITING

    Oxford, United Kingdom

  • Kettering General

    RECRUITING

    Kettering, United Kingdom

  • Leicester Royal Infirmary

    TERMINATED

    Leicester, United Kingdom

  • Newham University Hospital

    RECRUITING

    London, United Kingdom

  • Peterborough City Hospital

    RECRUITING

    Peterborough, United Kingdom

  • Queen Elizabeth University Hospital

    RECRUITING

    Glasgow, United Kingdom

  • Queens Hospital Barking

    RECRUITING

    Romford, United Kingdom

  • Royal Alexandra Hospital

    RECRUITING

    Paisley, United Kingdom

  • Royal Berkshire Hospital

    RECRUITING

    Reading, United Kingdom

  • Royal Blackburn Hospital

    TERMINATED

    Blackburn, United Kingdom

  • Royal Derby Hospital

    RECRUITING

    Derby, United Kingdom

  • Royal Infirmary of Edinburgh

    RECRUITING

    Edinburgh, United Kingdom

  • Royal Liverpool University Hospital

    RECRUITING

    Liverpool, United Kingdom

  • Royal London Hospital

    RECRUITING

    London, United Kingdom

  • Salford Royal

    RECRUITING

    Salford, United Kingdom

  • St George's

    TERMINATED

    London, United Kingdom

  • University Hospital Crosshouse

    TERMINATED

    Kilmarnock, United Kingdom

  • University Hospital Lewisham

    RECRUITING

    London, United Kingdom

  • University Hospital Monklands

    RECRUITING

    Lanark, United Kingdom

  • Victoria Hospital

    RECRUITING

    Fife Keith, United Kingdom

More trials for these conditions

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