Strong Albumin Solutions in Patients With Septic Shock (SWIPE2)

NHS Foundation Trust

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Shock, Toxic; Septic Shock; Sepsis

Treatments: Drug: hyperoncotic human albumin solution; Drug: Buffered crystalloid solutions

Study type: Interventional

Funder types: Other

Identifiers

NCT05208242

B01459

287590 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 organs such as the heart, lungs or kidneys. It is a life-threatening condition and even with prompt treatment as many as 1 in 4 patients with sepsis don't survive. Septic shock is a term used to describe the worst form of sepsis, where patients need life-supporting treatments in intensive care.

Guidelines recommend doctors give fluid to patients with sepsis. This aims to improve blood flow to vital organs and reduce the risk of further damage. However, there maybe risks if patients are given too much fluid, such as developing kidney failure or even death.

Human albumin solution is a type of fluid, made from blood donated by healthy volunteers. Albumin has been used safely for many years but is more expensive compared to other fluids. Alternative fluids include solutions of salts and water that closely match the contents of human blood. Some research suggests patients with sepsis might benefit from being given albumin, particularly those with septic shock, but doctors remain unsure on whether they should give it to patients with sepsis, or whether the additional expense is worthwhile.

The overall aims of this research

The aim of this research is to test whether it is possible to give patients with early septic shock strong solutions of albumin when they arrive in intensive care. The investigators will also begin to explore the financial costs of using albumin and whether they can be justified for patients treated in the NHS.

What will happen in this research?

The investigators will conduct a study of 50 patients who are admitted to intensive care with septic shock. Patients will be randomly divided into two groups. One group will receive albumin and the other standard salt solutions. Participating patients will provide blood and urine samples shortly after their arrival in intensive care and also 2 and 5 days later. All other aspects of care and treatment will remain the same. Patients will be observed and followed up to see how they are 6 months after entering the study.

What will happen with the results?

The findings of this research will be published in a medical journal and presented at meetings where other healthcare providers can hear of our work. Every participating patient will receive a written summary of the study results. Most importantly, the results of this study will help us move forward with further research into how albumin maybe used cost-effectively in patients with sepsis in the NHS.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Hyperoncotic albumin

Experimental group

Description:

Hyperoncotic albumin for all fluid resuscitation and also as a daily supplement, guided by daily serum albumin values, for up to 7 days.

Treatment:

Drug: hyperoncotic human albumin solution

Buffered crystalloids

Active Comparator group

Description:

Buffered crystalloid solutions for all fluid resuscitation and maintenance purposes. Participants in this arms will NOT receive any albumin during their participation.

Treatment:

Drug: Buffered crystalloid solutions