Using strong albumin solutions for patients with septic shock
Small Volume Fluid Resuscitation and Supplementation With 20% albumIn Versus Buffered Crystalloids in PatiEnts With Septic Shock
PHASE2; PHASE3 · Manchester University NHS Foundation Trust · NCT05208242
This study is testing if a special type of albumin solution can help people with septic shock recover better than regular fluids.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Manchester University NHS Foundation Trust (other gov) |
| Locations | 2 sites (Manchester, Lancashire and 1 other locations) |
| Trial ID | NCT05208242 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the feasibility of administering hyperoncotic albumin solutions as a form of fluid resuscitation in patients experiencing early septic shock. Sepsis is a critical condition that can lead to organ failure, and current guidelines recommend fluid therapy to improve blood flow to vital organs. The study will compare the effects of hyperoncotic albumin solutions against buffered crystalloid solutions in a randomized manner to determine the potential benefits and risks associated with this treatment approach.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with suspected or documented infections and organ dysfunction requiring intensive care.
Not a fit: Patients who may not benefit include those under 18 years of age, pregnant individuals, or those with known allergies to albumin.
Why it matters
Potential benefit: If successful, this study could provide a more effective fluid resuscitation method for patients with septic shock, potentially improving survival rates.
How similar studies have performed: While some studies have suggested potential benefits of albumin in sepsis, this specific approach is still being evaluated for its feasibility and efficacy.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Manchester, Lancashire and 1 other locations
- Manchester Royal Infirmary — Manchester, Lancashire, United Kingdom (RECRUITING)
- Wythenshawe Hospital — Manchester, Lancashire, United Kingdom (NOT_YET_RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sepsis, Septic Shock, Shock, Toxic, sepsis, septic shock, fluid therapy, hyperoncotic albumin