Small Volume Fluid Resuscitation and Supplementation With 20% albumIn Versus Buffered Crystalloids in PatiEnts With Septic Shock

Who is this study for? Patients with Sepsis
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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 preparations of human albumin solution are widely available, but their efficacy has yet to be proven. This randomised feasibility trial will test whether it is feasible to administer hyperoncotic albumin solutions as both fluid resuscitation and as a regular supplement in patients with early septic shock.

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

• 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

Locations
Other Locations
United Kingdom
Manchester Royal Infirmary
RECRUITING
Manchester
Wythenshawe Hospital
NOT_YET_RECRUITING
Manchester
Time Frame
Start Date: 2023-11-10
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 50
Treatments
Experimental: Hyperoncotic albumin
Hyperoncotic albumin for all fluid resuscitation and also as a daily supplement, guided by daily serum albumin values, for up to 7 days.
Active_comparator: Buffered crystalloids
Buffered crystalloid solutions for all fluid resuscitation and maintenance purposes. Participants in this arms will NOT receive any albumin during their participation.
Related Therapeutic Areas
Sponsors
Leads: Manchester University NHS Foundation Trust
Collaborators: University of Manchester

This content was sourced from clinicaltrials.gov