Status:
RECRUITING
Strong Albumin Solutions in Patients With Septic Shock
Lead Sponsor:
Manchester University NHS Foundation Trust
Collaborating Sponsors:
University of Manchester
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Sepsis is an increasingly recognised burden to healthcare systems worldwide. Intravenous fluid therapy is a common first-line intervention recommended by international guidelines. Hyperoncotic prepara...
Detailed Description
Background to this research Sepsis is the most severe type of infection. It happens when a patient's own immune system is trying to fight an infection, but causes damage or even failure to vital orga...
Eligibility Criteria
Inclusion
- Suspected or documented infection
- Organ dysfunction defined as SOFA score ≥2
- Need for vasopressor infusion for ≥2 hours
- Serum lactate ≥2 mmol/L
- Eligible for critical care admission without any restrictions
Exclusion
- \>24 hours since the time point of meeting all inclusion criteria
- \<18 years of age
- Pregnancy
- Patients with a known allergy to albumin
- Jehova's witnesses or other patients expressing a known objection to the use of blood products
- Previous receipt of human albumin solution for the episode of sepsis in question
- Previous enrolment in this study
Key Trial Info
Start Date :
November 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05208242
Start Date
November 10 2023
End Date
February 28 2026
Last Update
December 13 2023
Active Locations (2)
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1
Manchester Royal Infirmary
Manchester, Lancashire, United Kingdom, M13 9WL
2
Wythenshawe Hospital
Manchester, Lancashire, United Kingdom, M23 9LT