Study Results
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Basic Information
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RECRUITING
PHASE3
1005 participants
INTERVENTIONAL
2022-10-11
2027-10-31
Brief Summary
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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.
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Detailed Description
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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
1. Experience of use of any intravenous vasopressor in ED was high (81%);
2. Exclusive PVI made up 23% of all vasopressor use in ED;
3. Norepinephrine (norepinephrine) was the most common vasopressor (54%);
4. Barriers to PVI were local protocols and an appropriate level of care in the destination ward for a patient on vasopressor infusion.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Arm
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.
Norepinephrine
Norepinepherine should be prepared and delivered at a concentration of 16 micrograms/ml
Standard care
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.
Balanced Crystalloid
IV fluids administered as per standard care
Interventions
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Norepinephrine
Norepinepherine should be prepared and delivered at a concentration of 16 micrograms/ml
Balanced Crystalloid
IV fluids administered as per standard care
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Edinburgh
OTHER
Northern Care Alliance NHS Foundation Trust
OTHER
University of Manchester
OTHER
University of Glasgow
OTHER
NHS Lothian
OTHER_GOV
Chelsea and Westminster NHS Foundation Trust
OTHER
NHS Greater Glasgow and Clyde
OTHER
Responsible Party
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Locations
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Aintree University Hospital
Aintree, , United Kingdom
Royal Blackburn Hospital
Blackburn, , United Kingdom
Fairfield General Hospital
Bury, , United Kingdom
Royal Derby Hospital
Derby, , United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Victoria Hospital
Fife Keith, , United Kingdom
Glasgow Royal Infirmary
Glasgow, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Hull Royal Infirmary
Hull, , United Kingdom
Kettering General
Kettering, , United Kingdom
University Hospital Crosshouse
Kilmarnock, , United Kingdom
University Hospital Monklands
Lanark, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Royal London Hospital
London, , United Kingdom
St George's
London, , United Kingdom
University Hospital Lewisham
London, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Royal Alexandra Hospital
Paisley, , United Kingdom
Peterborough City Hospital
Peterborough, , United Kingdom
Royal Berkshire Hospital
Reading, , United Kingdom
Queens Hospital Barking
Romford, , United Kingdom
Salford Royal
Salford, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2021-006886-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GN20AE342
Identifier Type: -
Identifier Source: org_study_id
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