RecruitingPhase 3

Early Vasopressors in Sepsis

United Kingdom1,006 participantsStarted 2022-10-11

Plain-language 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 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 ferti…

What they're measuring

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.

Timeframe: 90 days post randomisation

Trial details

NCT IDNCT05179499

SponsorNHS Greater Glasgow and Clyde

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11

Contact for this trial

Hannah Greenwood

0141 314 4366 Hannah.Greenwood@nhs.scot