SepsisPhase 3EVISNCT05179499
Early Vasopressors in Sepsis
A Phase 3 study testing Norepinephrine and Balanced Crystalloid in people with Sepsis, run by NHS Greater Glasgow and Clyde at 25 sites in United Kingdom.
Trial summary
Sepsis is a life-threatening reaction to an infection. It happens when the immune system overreacts to an infection and starts to damage the body's tissues and organs. The aim of this research study is to compare the two different ways to treat sepsis, in the early phase of treatment immediately after the participants… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Norepinephrine and Balanced Crystalloid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,006 participants
- Where
- 25 sitesUnited Kingdom
- Study dates
- 11 Oct 2022to Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- >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)
Show all 13Show fewer
- 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
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Alasdair Corfield contact
25 sites in 1 country
United Kingdom25 sites, 21 recruiting
- Recruiting
Aintree University Hospital
Aintree
Ben Morton
- Terminated
Royal Blackburn Hospital
Blackburn
- Recruiting
Fairfield General Hospital
Bury
Scott Houston
- Recruiting
Addenbrookes Hospital, Cambridge
Cambridge
David Leverton
- Recruiting
Royal Derby Hospital
Derby
Andrew Tabner
- Recruiting
Royal Infirmary of Edinburgh
Edinburgh
Alasdair Gray
- Recruiting
Victoria Hospital
Fife Keith
Rajendra Raman
- Recruiting
Glasgow Royal Infirmary
Glasgow
Donogh Maguire
- Recruiting
Queen Elizabeth University Hospital
Glasgow
David Lowe
- Recruiting
Hull Royal Infirmary
Hull
Jack Preece
- Recruiting
Kettering General
Kettering
Maria iliescu
- Terminated
University Hospital Crosshouse
Kilmarnock
- Recruiting
University Hospital Monklands
Lanark
Nicola Moultrie
- Terminated
Leicester Royal Infirmary
Leicester
- Recruiting
Royal Liverpool University Hospital
Liverpool
Ned Gilbert-Kawai
- Recruiting
Newham University Hospital
London
Ben Bloom
Emma Young
- Recruiting
Royal London Hospital
London
Ben Bloom
- Terminated
St George's
London
- Recruiting
University Hospital Lewisham
London
anna colclough
- Recruiting
John Radcliffe Hospital
Oxford
Deon Louw
- Recruiting
Royal Alexandra Hospital
Paisley
Santosh Bongale
- Recruiting
Peterborough City Hospital
Peterborough
Christopher Edmunds
- Recruiting
Royal Berkshire Hospital
Reading
Matthew Frise
- Recruiting
Queens Hospital Barking
Romford
Darryl Wood
- Recruiting
Salford Royal
Salford
Daniel Horner
About this study
Sepsis is a life-threatening reaction to an infection. It happens when the immune system overreacts to an infection and starts to damage the body's tissues and organs.
The aim of this research study is to compare the two different ways to treat sepsis, in the early phase of treatment immediately after the participants arrive in hospital. The standard approach is to give a salt solution fluid through a drip in the participants arm to start with, then adding in a medication that increases the blood flow to the participants vital organs (a vasopressor mediation called norepinephrine) if required. The alternative approach is to start the vasopressor medication immediately, and then add in extra salt solution fluid via a drip if required. Vasopressors work by increasing the blood pressure which allows a better blood flow to the internal organs. The investigators plan to see which approach is better and to see if they have a role in improving a patient's recovery time, reducing complications, the length of time they stay in hospital and longer term poor health.
Based on research that has already been done, the investigators believe treating patients with vasopressors when they arrive in the Emergency Department, may have potential advantages over the standard fluids used today. However, the evidence is not clear and that is why this research is being done.
Read the detailed description
Sepsis results from overwhelming reactions to microbial infections where the immune system initiates dysregulated responses that lead to remote organ dysfunction, shock and ultimately death. Sepsis remains a significant global issue - as well as direct mortality, survivors suffer long term reductions in patient centred outcomes, with reduced quality of life and functional status. Patients with hypotension and organ hypoperfusion as a result of sepsis have poorer outcomes by dysregulated inflammation, endothelial dysfunction, immune suppression, and organ dysfunction. Current guidelines highlight the importance of early fluid resuscitation, but the association of early fluid therapy with improved outcomes is unclear. In the resuscitation phase, current practice is to give intravenous (IV) fluid and intermittent vasopressor boluses if required, before, for some patients, continuous vasopressor infusion via a central venous line in Intensive Care (ICU). An alternative, early continuous peripheral vasopressor infusion (PVI) is not routine practice in the UK.
Current practice in the UK is guided by NICE Sepsis guidance and the international Surviving Sepsis Campaign (SSC) consensus recommendations. Both specify intravenous fluid administration as a central tenet of early resuscitation of patients with septic shock, with intravenous vasopressor administration recommended after intravenous fluid resuscitation. NICE recommend boluses of 500ml of crystalloid and "refer to critical care for review of management including need for central venous access and initiation of vasopressors". SSC recommend 30ml/kg crystalloid in first hour, followed by vasopressors to maintain MAP>65.
The current NICE fluid resuscitation guideline, November 2020, continues to emphasise 500ml boluses of crystalloid as usual care. A recent international survey of 100 critical care and EM physicians regarding intravenous fluid resuscitation practice, confirmed that an initial bolus of 1000ml of crystalloid, followed by 500ml boluses of crystalloid remained the most common management strategy for the initial treatment of septic shock. This persisted despite the lack of benefit demonstrated in three landmark trials of protocolised sepsis management.
In recent years, there has been increasing acceptance of peripheral administration of norepinephrine, based on evidence of safety and efficacy. The Intensive Care Society published guidance on peripheral vasopressor infusion in November 2020. We have recently conducted a survey amongst ED and ICU clinicians in the UK regarding attitudes and current practice related to the use of intravenous peripheral vasopressors. Eighty two respondents provided the following answers
- Experience of use of any intravenous vasopressor in ED was high (81%);
- Exclusive PVI made up 23% of all vasopressor use in ED;
- Norepinephrine (norepinephrine) was the most common vasopressor (54%);
- Barriers to PVI were local protocols and an appropriate level of care in the destination ward for a patient on vasopressor infusion.
- Conditions
- Sepsis
- Being tested
- Norepinephrine, Balanced Crystalloid
- Keywords
- Sepsis, Resuscitation, Norepinephrine, Intravenous fluids, Emergency Medicine, Critical Care
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
Norepinepherine should be prepared and delivered at a concentration of 16 micrograms/ml
Balanced CrystalloidOther
IV fluids administered as per standard care
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Active comparator | Participants will receive peripheral vasopressor infusion of norepinephrine (16 micrograms/ml) during the initial 48 hour study period. All other care will be as per local protocol. Receives: Drug: Norepinephrine |
| Standard care | Placebo comparator | Participants allocated to the control arm will receive standard care as defined by the UK NICE guidelines and the Surviving Sepsis Campaign guidelines during the 48 hour study period post randomisation. All other care will be as per local protocol. Receives: Other: Balanced Crystalloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to determine whether early PVI (within 12 hours of admission) targeted to MAP of ≥65 mmHg improves clinical effectiveness in hospitalised adult patients with septic shock compared with usual care, in the first 48 hours.
The primary objective is measured by the Primary outcome of 'Days Alive and Out of Hospital at 90 Days'.
Measured: 90 days post randomisation
Secondary outcomes (17)
Accumulated Total Volume of IV fluid
Accumulated volume of IV fluid delivered in each arm - excluding fluid volumes less than 100ml
Measured: 6,12, 24, 48 and 72 hours post randomisation
Lactate clearance from baseline
Blood lactate value - arterial or venous
Measured: 6, 12, 24, 48 & 72 hours post randomisation
Total Dose of Norepinephrine
Total dose of norepinephrine delivered by any route (peripheral or central) at each timepoint
Measured: 6, 12, 24, 48 and 72 hours post randomisation
Proportion of patients who receive vasopressors
Proportion of patients recruited to control arm who receive any vasopressor (norepinephrine, vasopressin, metarminol, epinephrine) at each time point
Measured: 6, 12, 24 and 48 hours after recruitment to the control arm
Proportion of patients who require central venous access
Decision to treat based on treating clinician judgement
Measured: 24 and 48 hours post randomisation
Proportion of patients developing acute kidney injury
Acute kidney injury in line with the (p) RIFLE (paediatric Risk, Injury, Failure, Loss, End stage renal disease, AKIN (Acute kidney injury network) or KDIGO (Kidney Disease: Improving Global Outcomes) definitions by using any of the following criteria
- a rise in serum creatinine of 26 micromol/litre or greater within 48 hours
- a 50% or greater rise in serum creatinine known or presumed to have occurred within the past 7 days
- a fall in urine output to less than 0.5 ml/kg/hour for more than 6 hours in adults
Measured: During the first 72 hours post randomisation
Proportion of patients receiving parenteral corticosteroid
defined as new prescription of parenteral corticosteroid
Measured: 24, 48 & 72 hours post randomisation
Length of hospital stay for index admission
index hospital admission ends when the patient is discharged from the facility providing definitive treatment for the episode of sepsis leading to inclusion in the study
Measured: up to hospital discharge
Proportion of participants needing renal replacement therapy during index hospital admission
decision to treat based on treating clinician judgement; participants who receive new renal replacement therapy; participants with chronic renal replacement initiated prior to the index admission will not be eligible to meet this endpoint
Measured: index admission
Proportion of participants needing non-invasive ventilation during index hospital admission
decision to treat based on treating clinician judgement; defined as admissions receiving mask/hood CPAP or mask/hood BiPAP or non-invasive ventilation; admissions receiving CPAP via a tracheostomy
Measured: index admission
Proportion of participants needing advanced respiratory support (ICNARC definition)
decision to treat based on treating clinician judgement; Patients who receive one or more of the following: A. Patients who receive invasive mechanical ventilation via endotracheal or tracheostomy tube, except those intubated solely for a procedure and extubated within 24 hours B. BiPAP (bilevel positive airway pressure) applied via a trans-laryngeal tracheal tube or applied via a tracheostomy C. CPAP (continuous positive airway pressure) via a translaryngeal tune of applied via a tracheostomy D. extracorporeal respiratory support
Measured: index admission
Total dose of other vasopressor
Total dose of other vasopressors delivered by any route (peripheral or central) at each timepoint
Measured: 6, 12, 24, 48, 72 hours post randomisation
All-cause mortality during index hospital admission and at 30 and 90 days
All-cause mortality during index hospital admission and at 30 \& 90 days post randomisation
Measured: index admission and at 30 & 90 days post randomisation
Readmission, post initial hospital discharge, in first 30 days and 90 days post randomisation
Re-admission to an acute healthcare facility in the first 30 \& 90 days post randomisation, following a discharge from the index hospital admission to the participants care setting in the community. This includes planned and unplanned admissions. For both readmission outcomes, an acute care facility is any acute care hospital, emergency department admission >24 hours, critical care area or short stay admission or observation area.
Measured: 30 & 90 days post randomisation
Proportion of participants admitted to and length of stay in critical care (level 2 or 3) during index hospital admission
Proportion of participants admitted to and length of stay in critical care (level 2 or 3) during index hospital admission
Measured: During Index Hospital Admission
Discharge Diagnosis
Main diagnosis for index hospital admission, and all subsequent re-admissions
Measured: At initial Index Hospital Discharge & at any subsequent hospital discharges following any re-admissions (post Initial Index Hospital Discharge) 90 days post randomisation.
HRQoL
Derived from EQ-5D-5L index values
Measured: Baseline, 30 & 90 Days Post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start11 Oct 2022
- Primary completionNov 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label, two arm, multicentre, pragmatic parallel group randomised trial with an internal pilot
- Masking
- None (open label)
- Enrolment
- 1,006 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Edinburgh, Northern Care Alliance NHS Foundation Trust, University of Manchester, University of Glasgow, NHS Lothian, Chelsea and Westminster NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179499
- Sponsor's protocol ID
- GN20AE342
- Other IDs
- 2021-006886-39
- Acronym
- EVIS
- Status last verified
- Feb 2026
- First submitted
- 11 Nov 2021
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: to be confirmed
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Vasopressors in Sepsis
- ClinicalTrials.gov ID
- NCT05179499
- Acronym / sponsor ID
- EVIS / GN20AE342
- Conditions
- Sepsis
- Keywords
- Sepsis, Resuscitation, Norepinephrine, Intravenous fluids, Emergency Medicine, Critical Care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,006 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Edinburgh, Northern Care Alliance NHS Foundation Trust, University of Manchester, University of Glasgow, NHS Lothian, Chelsea and Westminster NHS Foundation Trust
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sepsis is a life-threatening reaction to an infection. It happens when the immune system overreacts to an infection and starts to damage the body's tissues and organs.
The aim of this research study is to compare the two different ways to treat sepsis, in the early phase of treatment immediately after the participants arrive in hospital. The standard approach is to give a salt solution fluid through a drip in the participants arm to start with, then adding in a medication that increases the blood flow to the participants vital organs (a vasopressor mediation called norepinephrine) if required. The alternative approach is to start the vasopressor medication immediately, and then add in extra salt solution fluid via a drip if required. Vasopressors work by increasing the blood pressure which allows a better blood flow to the internal organs. The investigators plan to see which approach is better and to see if they have a role in improving a patient's recovery time, reducing complications, the length of time they stay in hospital and longer term poor health.
Based on research that has already been done, the investigators believe treating patients with vasopressors when they arrive in the Emergency Department, may have potential advantages over the standard fluids used today. However, the evidence is not clear and that is why this research is being done.
Detailed description
Sepsis results from overwhelming reactions to microbial infections where the immune system initiates dysregulated responses that lead to remote organ dysfunction, shock and ultimately death. Sepsis remains a significant global issue - as well as direct mortality, survivors suffer long term reductions in patient centred outcomes, with reduced quality of life and functional status. Patients with hypotension and organ hypoperfusion as a result of sepsis have poorer outcomes by dysregulated inflammation, endothelial dysfunction, immune suppression, and organ dysfunction. Current guidelines highlight the importance of early fluid resuscitation, but the association of early fluid therapy with improved outcomes is unclear. In the resuscitation phase, current practice is to give intravenous (IV) fluid and intermittent vasopressor boluses if required, before, for some patients, continuous vasopressor infusion via a central venous line in Intensive Care (ICU). An alternative, early continuous peripheral vasopressor infusion (PVI) is not routine practice in the UK.
Current practice in the UK is guided by NICE Sepsis guidance and the international Surviving Sepsis Campaign (SSC) consensus recommendations. Both specify intravenous fluid administration as a central tenet of early resuscitation of patients with septic shock, with intravenous vasopressor administration recommended after intravenous fluid resuscitation. NICE recommend boluses of 500ml of crystalloid and "refer to critical care for review of management including need for central venous access and initiation of vasopressors". SSC recommend 30ml/kg crystalloid in first hour, followed by vasopressors to maintain MAP>65.
The current NICE fluid resuscitation guideline, November 2020, continues to emphasise 500ml boluses of crystalloid as usual care. A recent international survey of 100 critical care and EM physicians regarding intravenous fluid resuscitation practice, confirmed that an initial bolus of 1000ml of crystalloid, followed by 500ml boluses of crystalloid remained the most common management strategy for the initial treatment of septic shock. This persisted despite the lack of benefit demonstrated in three landmark trials of protocolised sepsis management.
In recent years, there has been increasing acceptance of peripheral administration of norepinephrine, based on evidence of safety and efficacy. The Intensive Care Society published guidance on peripheral vasopressor infusion in November 2020. We have recently conducted a survey amongst ED and ICU clinicians in the UK regarding attitudes and current practice related to the use of intravenous peripheral vasopressors. Eighty two respondents provided the following answers
- Experience of use of any intravenous vasopressor in ED was high (81%);
- Exclusive PVI made up 23% of all vasopressor use in ED;
- Norepinephrine (norepinephrine) was the most common vasopressor (54%);
- Barriers to PVI were local protocols and an appropriate level of care in the destination ward for a patient on vasopressor infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, two arm, multicentre, pragmatic parallel group randomised trial with an internal pilot
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Active comparator | Drug: NorepinephrineParticipants will receive peripheral vasopressor infusion of norepinephrine (16 micrograms/ml) during the initial 48 hour study period. All other care will be as per local protocol. |
| Standard care | Placebo comparator | Other: Balanced CrystalloidParticipants allocated to the control arm will receive standard care as defined by the UK NICE guidelines and the Surviving Sepsis Campaign guidelines during the 48 hour study period post randomisation. All other care will be as per local protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- >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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NorepinephrineNorepinepherine should be prepared and delivered at a concentration of 16 micrograms/ml | Drug | Intervention Arm |
| Balanced CrystalloidIV fluids administered as per standard care | Other | Standard care |
Primary outcome
The primary objective is to determine whether early PVI (within 12 hours of admission) targeted to MAP of ≥65 mmHg improves clinical effectiveness in hospitalised adult patients with septic shock compared with usual care, in the first 48 hours.
Time frame: 90 days post randomisation
The primary objective is measured by the Primary outcome of 'Days Alive and Out of Hospital at 90 Days'.
17 secondary outcomes
Accumulated Total Volume of IV fluid
Time frame: 6,12, 24, 48 and 72 hours post randomisation
Lactate clearance from baseline
Time frame: 6, 12, 24, 48 & 72 hours post randomisation
Total Dose of Norepinephrine
Time frame: 6, 12, 24, 48 and 72 hours post randomisation
Proportion of patients who receive vasopressors
Time frame: 6, 12, 24 and 48 hours after recruitment to the control arm
Proportion of patients who require central venous access
Time frame: 24 and 48 hours post randomisation
Proportion of patients developing acute kidney injury
Time frame: During the first 72 hours post randomisation
Proportion of patients receiving parenteral corticosteroid
Time frame: 24, 48 & 72 hours post randomisation
Length of hospital stay for index admission
Time frame: up to hospital discharge
Proportion of participants needing renal replacement therapy during index hospital admission
Time frame: index admission
Proportion of participants needing non-invasive ventilation during index hospital admission
Time frame: index admission
Proportion of participants needing advanced respiratory support (ICNARC definition)
Time frame: index admission
Total dose of other vasopressor
Time frame: 6, 12, 24, 48, 72 hours post randomisation
All-cause mortality during index hospital admission and at 30 and 90 days
Time frame: index admission and at 30 & 90 days post randomisation
Readmission, post initial hospital discharge, in first 30 days and 90 days post randomisation
Time frame: 30 & 90 days post randomisation
Proportion of participants admitted to and length of stay in critical care (level 2 or 3) during index hospital admission
Time frame: During Index Hospital Admission
Discharge Diagnosis
Time frame: At initial Index Hospital Discharge & at any subsequent hospital discharges following any re-admissions (post Initial Index Hospital Discharge) 90 days post randomisation.
HRQoL
Time frame: Baseline, 30 & 90 Days Post randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No. to be confirmed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alasdair Corfield contact
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Norepinephrine and Balanced Crystalloid in people with Sepsis, run by NHS Greater Glasgow and Clyde at 25 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Greenwood (0141 314 4366, Hannah.Greenwood@nhs.scot), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to determine whether early PVI (within 12 hours of admission) targeted to MAP of ≥65 mmHg improves clinical effectiveness in hospitalised adult patients with septic shock compared with usual care, in the first 48 hours. (time frame: 90 days post randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.