Clinical trial NCT05208242: Strong Albumin Solutions in Patients With Septic Shock
Official title: Small Volume Fluid Resuscitation and Supplementation With 20% albumIn Versus Buffered Crystalloids in PatiEnts With Septic Shock
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Sepsis
Septic Shock
Shock, Toxic
Keywords: sepsis
septic shock
fluid therapy
hyperoncotic albumin
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Manchester
First posted: 2022-01-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multi-centre, randomised, open-label, feasibility study.
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility 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

Primary outcomes:
measure: Participant recruitment rate
timeFrame: 24 months after opening the trial
Secondary outcomes:
measure: Vasopressor use
timeFrame: hourly values for up to 7-days
measure: Survival
timeFrame: 90-days after enrolment
measure: Healthcare costs
timeFrame: 90-days after enrolment
measure: Quality of Life of study participants
timeFrame: 90-days after enrolment
measure: Cumulative fluid balance (in millilitres)
timeFrame: daily values for up to 7 days
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
state: Lancashire
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
state: Lancashire
Study officials:
References: