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Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID05179499

Early Vasopressors in Sepsis Comparing Peripheral Norepinephrine Infusion to Standard Fluid Therapy in Hospitalized Adults with Septic Shock

Led by NHS Greater Glasgow and Clyde · Updated on 2026-02-12

1006

Participants Needed

25

Research Sites

47 weeks

Total Duration

On this page

Sponsors

N

NHS Greater Glasgow and Clyde

Lead Sponsor

U

University of Edinburgh

Collaborating Sponsor

AI-Summary

What this Trial Is About

Sepsis is a serious condition caused by the bodys extreme response to an infection, leading to tissue and organ damage. This research compares two early treatment methods for sepsis immediately after hospital arrival, focusing on whether starting vasopressor medication right away or beginning with fluid therapy improves patient recovery and reduces complications. The study is a Phase 3 trial aimed at finding the best approach to improve outcomes for adults with septic shock. Participants are divided into two groups one receives a continuous peripheral vasopressor infusion of norepinephrine during the first 48 hours, while the other group receives standard care guided by UK NICE and Surviving Sepsis Campaign guidelines, which starts with intravenous fluids and adds vasopressors as needed. Both treatments follow local hospital protocols beyond the initial interventions. During the study, participants will be closely monitored for blood pressure, fluid volume, lactate levels, and other health indicators at multiple time points up to 90 days after randomization. Researchers will assess outcomes including hospital stay length, need for additional therapies like renal replacement or respiratory support, and overall survival. Quality of life and readmission rates will also be evaluated to understand the longer-term effects of the treatments.

CONDITIONS

Brief Title

Early Vasopressors in Sepsis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Clinically suspected or proven infection causing acute illness
  • Systolic blood pressure less than 90 mmHg or mean arterial pressure less than 65 mmHg within an hour of eligibility assessment
  • Serum lactate greater than 2 mmol/L measured within 2 to 4 hours prior to eligibility assessment
  • Hospital presentation within the last 12 hours
Not Eligible

You will not qualify if you...

  • Received more than 1500 ml of intravenous fluid before screening
  • Need for immediate surgery within one hour
  • Immediate requirement for central venous access
  • Chronic renal replacement therapy
  • Known allergy or adverse reaction to norepinephrine
  • Receiving palliative or end of life care
  • Previous participation in this trial
  • Permanent incapacity
  • Pregnancy or positive pregnancy test in women of childbearing potential
  • Other primary causes of shock such as cardiogenic or hemorrhagic shock
  • Medical, neurological, or psychological conditions posing undue risk
  • Participation in other investigational drug trials

Research Team

H

Hannah Greenwood

A

Alasdair Corfield

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