Early Vasopressors in Sepsis

Who is this study for? Patients with Sepsis
Status: Recruiting
Location: See all (23) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Aintree University Hospital
NOT_YET_RECRUITING
Aintree
Royal Blackburn Hospital
RECRUITING
Blackburn
Fairfield General Hospital
ACTIVE_NOT_RECRUITING
Bury
Royal Derby Hospital
RECRUITING
Derby
Royal Infirmary of Edinburgh
RECRUITING
Edinburgh
Victoria Hospital
RECRUITING
Fife Keith
Glasgow Royal Infirmary
ACTIVE_NOT_RECRUITING
Glasgow
Queen Elizabeth University Hospital
ACTIVE_NOT_RECRUITING
Glasgow
Hull Royal Infirmary
RECRUITING
Hull
Kettering General
RECRUITING
Kettering
University Hospital Crosshouse
NOT_YET_RECRUITING
Kilmarnock
University Hospital Monklands
RECRUITING
Lanark
Leicester Royal Infirmary
ACTIVE_NOT_RECRUITING
Leicester
Royal Liverpool University Hospital
NOT_YET_RECRUITING
Liverpool
Royal London Hospital
RECRUITING
London
St George's
RECRUITING
London
University Hospital Lewisham
NOT_YET_RECRUITING
London
John Radcliffe Hospital
ACTIVE_NOT_RECRUITING
Oxford
Royal Alexandra Hospital
RECRUITING
Paisley
Peterborough City Hospital
RECRUITING
Peterborough
Royal Berkshire Hospital
RECRUITING
Reading
Queens Hospital Barking
ACTIVE_NOT_RECRUITING
Romford
Salford Royal
RECRUITING
Salford
Contact Information
Primary
Hannah Greenwood
Hannah.Greenwood@nhs.scot
0141 314 4366
Backup
Alasdair Corfield
Alasdair.corfield2@nhs.scot
Time Frame
Start Date: 2022-10-11
Estimated Completion Date: 2027-10
Participants
Target number of participants: 1005
Treatments
Active_comparator: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Chelsea and Westminster NHS Foundation Trust, Northern Care Alliance NHS Foundation Trust, University of Glasgow, University of Manchester, NHS Lothian, University of Edinburgh
Leads: NHS Greater Glasgow and Clyde

This content was sourced from clinicaltrials.gov