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โ† Trials
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Early Vasopressors in Sepsis

RecruitingPhase 3Ages 18 Years - anyAllNHS Greater Glasgow and Clyde
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • Norepinephrine
  • Balanced Crystalloid
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Where

25 sites
Aintree University Hospital
Aintree, United Kingdom
Royal Blackburn Hospital
Blackburn, United Kingdom
Fairfield General Hospital
Bury, United Kingdom
Addenbrookes Hospital, Cambridge
Cambridge, 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

โ€ฆand 17 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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