SepsisPhase 2/3SWIPE2NCT05208242
Strong Albumin Solutions in Patients With Septic Shock
A Phase 2/3 study testing hyperoncotic human albumin solution and Buffered crystalloid solutions in people with Sepsis and Septic Shock, run by Manchester University NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Shock, Toxic
- What is being tested?
- hyperoncotic human albumin solution and Buffered crystalloid solutions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 10 Nov 2023to 31 Jan 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- >24 hours since the time point of meeting all inclusion criteria
- <18 years of age
- Pregnancy
- Patients with a known allergy to albumin
- Jehova's witnesses or other patients expressing a known objection to the use of blood products
- Previous receipt of human albumin solution for the episode of sepsis in question
- Previous enrolment in this study
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Manchester Royal Infirmary
Manchester, Lancashire, M13 9WL
Wythenshawe Hospital
Manchester, Lancashire, M23 9LT
About this study
Official title: Small Volume Fluid Resuscitation and Supplementation With 20% albumIn Versus Buffered Crystalloids in PatiEnts With Septic Shock
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.
Read the 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.
- Conditions
- Sepsis, Septic Shock, Shock, Toxic
- Being tested
- hyperoncotic human albumin solution, Buffered crystalloid solutions
- Keywords
- sepsis, septic shock, fluid therapy, hyperoncotic albumin
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperoncotic human albumin solutionDrug
20% human albumin solution (presented in 100ml glass bottles)
Buffered crystalloid solutionsDrug
Also called Hartmann's solution, Compound Sodium Lactate
Buffered crystalloids solutions for all intravenous fluid therapy
| Study group | Role | What they receive |
|---|---|---|
| Hyperoncotic albumin | Experimental | Hyperoncotic albumin for all fluid resuscitation and also as a daily supplement, guided by daily serum albumin values, for up to 7 days. Receives: Drug: hyperoncotic human albumin solution |
| Buffered crystalloids | Active comparator | Buffered crystalloid solutions for all fluid resuscitation and maintenance purposes. Participants in this arms will NOT receive any albumin during their participation. Receives: Drug: Buffered crystalloid solutions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant recruitment rate
Evidence to confirm feasibility of the study protocol without any further modification for a future efficacy trial. This will be objectively determined by a recruitment rate of >2 participants per month, resulting in study recruitment being completed within 24 months of opening the trial. A pre-specified threshold of >80% of the anticipated recruitment rate would support the feasibility of a future efficacy trial.
Measured: 24 months after opening the trial
Secondary outcomes (5)
Vasopressor use
The hourly use of vasopressor infusions from enrolment in mcg/kg/min
Measured: hourly values for up to 7-days
Survival
Number of participants who survive
Measured: 90-days after enrolment
Healthcare costs
Healthcare service use and costs. These will be estimated using a participant's medical records to estimate the cost of their hospital admission episode. Data on further healthcare costs will be acquired through the 90-day follow-up where participants will be asked about the healthcare service use since their discharge from hospital. All costs will be calculated in £GBP, with current equivalents in Euros and USD.
Measured: 90-days after enrolment
Quality of Life of study participants
Healthcare related quality of life as measured by the EuroQol Research Foundation's EQ-5D-5L questionnaire via telephone. This widely validated tool assesses healthcare related quality of life across 5 domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each domain is scored across 5 levels, with 1 indicating 'no problems' and 5 indicating 'unable to/extreme problems'. The questionnaire also includes a self-reported health score using a visual analogue scale. This EQ-VAS derives a total health score from 0 to 100, with 100 indicating the best health a participant can imagine, and 0 indicating the worst heath imaginable.
Measured: 90-days after enrolment
Cumulative fluid balance (in millilitres)
This daily measure of total fluid administered minus total fluid out reflects the daily amount of fluid accumulated by participants. It will be measured on a daily basis with summary comparisons made at day 7.
Measured: daily values for up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start10 Nov 2023
- Primary completion5 Apr 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multi-centre, randomised, open-label, feasibility study.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Manchester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208242
- Sponsor's protocol ID
- B01459
- Other IDs
- 287590
- Acronym
- SWIPE2
- Status last verified
- Feb 2026
- First submitted
- 13 Dec 2021
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Volume Fluid Resuscitation and Supplementation With 20% albumIn Versus Buffered Crystalloids in PatiEnts With Septic Shock
- ClinicalTrials.gov ID
- NCT05208242
- Acronym / sponsor ID
- SWIPE2 / B01459
- Conditions
- Sepsis, Septic Shock, Shock, Toxic
- Keywords
- sepsis, septic shock, fluid therapy, hyperoncotic albumin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- University of Manchester
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 5 Apr 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A multi-centre, randomised, open-label, feasibility study.
| Arm | Type | Receives |
|---|---|---|
| Hyperoncotic albumin | Experimental | Drug: hyperoncotic human albumin solutionHyperoncotic albumin for all fluid resuscitation and also as a daily supplement, guided by daily serum albumin values, for up to 7 days. |
| Buffered crystalloids | Active comparator | Drug: Buffered crystalloid solutionsBuffered crystalloid solutions for all fluid resuscitation and maintenance purposes. Participants in this arms will NOT receive any albumin during their participation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- >24 hours since the time point of meeting all inclusion criteria
- <18 years of age
- Pregnancy
- Patients with a known allergy to albumin
- Jehova's witnesses or other patients expressing a known objection to the use of blood products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyperoncotic human albumin solution20% human albumin solution (presented in 100ml glass bottles) | Drug | Hyperoncotic albumin |
| Buffered crystalloid solutionsAlso: Hartmann's solution, Compound Sodium LactateBuffered crystalloids solutions for all intravenous fluid therapy | Drug | Buffered crystalloids |
Primary outcome
Participant recruitment rate
Time frame: 24 months after opening the trial
Evidence to confirm feasibility of the study protocol without any further modification for a future efficacy trial. This will be objectively determined by a recruitment rate of >2 participants per month, resulting in study recruitment being completed within 24 months of opening the trial. A pre-specified threshold of >80% of the anticipated recruitment rate would support the feasibility of a future efficacy trial.
5 secondary outcomes
Vasopressor use
Time frame: hourly values for up to 7-days
Survival
Time frame: 90-days after enrolment
Healthcare costs
Time frame: 90-days after enrolment
Quality of Life of study participants
Time frame: 90-days after enrolment
Cumulative fluid balance (in millilitres)
Time frame: daily values for up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing hyperoncotic human albumin solution and Buffered crystalloid solutions in people with Sepsis and Septic Shock, run by Manchester University NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant recruitment rate (time frame: 24 months after opening the trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.