Strong Albumin Solutions in Patients With Septic Shock

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Manchester University NHS Foundation Trust
• Collaborator: University of Manchester
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. Suspected or documented infection

2. Organ dysfunction defined as SOFA score ≥2

3. Need for vasopressor infusion for ≥2 hours

4. Serum lactate ≥2 mmol/L

5. Eligible for critical care admission without any restrictions

Exclusion Criteria:

1. >24 hours since the time point of meeting all inclusion criteria

2. <18 years of age

3. Pregnancy

4. Patients with a known allergy to albumin

5. Jehova's witnesses or other patients expressing a known objection to the use of blood products

6. Previous receipt of human albumin solution for the episode of sepsis in question

7. Previous enrolment in this study