SepsisPhase 3ABC SepsisNCT04540094
Feasibility of 5% Albumin Compared With Balanced Crystalloid, as Intravenous Fluid Resuscitation in Adult Patients With Sepsis, Presenting as an Emergency to Hospital
A Phase 3 study testing Human albumin and Balanced crystalloid solution in people with Sepsis, run by University of Edinburgh at 15 sites in United Kingdom.
Trial summary
The aim of this research study is to compare two different fluids (Human Albumin Solution (HAS) and Balanced Crystalloid that are given via a drip to patients with severe infection (sepsis). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Human albumin and Balanced crystalloid solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 15 sitesUnited Kingdom
- Study dates
- 1 Jun 2021to 30 Apr 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult patients (18 years or older) who present to UK NHS hospitals with community acquired sepsis meeting all of the 4 criteria:
- Clinically suspected or proven infection resulting in principal reason for acute illness;
- NEWS score ≥5 (or NEWS2 if adopted in recruitment site);
- Hospital presentation within last 12hrs; and
- Clinician decision has been made that immediate (within 1 hour) intravenous fluid resuscitation is needed.
Who cannot join
- >1 litre of intravenous crystalloid fluid or any intravenous HAS administered prior to eligibility assessment;
- Requirement for immediate surgery (within one hour of eligibility assessment);
- Chronic renal replacement therapy;
- Known allergy/adverse reaction to HAS;
- Balanced crystalloid or HAS not available;
- Known adverse reaction to blood products;
Show all 12Show fewer
- Palliation/end of life care (explicit decision by patient/family/carers in conjunction with clinical team that any active treatment beyond symptomatic relief is not appropriate);
- Religious beliefs precluding HAS administration;
- Previous recruitment in the trial;
- Known recent severe traumatic brain injury (within 3 months);
- Patients with permanent incapacity;
- Known recruitment in another CTIMP studies within the last 30 days where co-enrolment has not been agreed.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United Kingdom15 sites
Aberdeen Royal Infirmary
Aberdeen
Addenbrookes Hospital
Cambridge
Derby Teaching Hosptial NHS Foundation Trust
Derby
Royal Infirmary Edinburgh
Edinburgh
Royal Devon and Exeter Hospital
Exeter
Glasgow Royal Infirmary
Glasgow
Queen Elizabeth University Hospital
Glasgow
St Johns
Livingston
St Georges Hospital
London
University College London Hospital
London
John Radcliffe Hospital
Oxford
Royal Alexandra Hospital
Paisley
Derriford Hospital Plymouth
Plymouth
Salford Royal NHS Foundation Trust
Salford
Musgrove Park Hospital
Taunton
About this study
Official title: Feasibility of 5% Albumin Compared With Balanced Crystalloid, as Intravenous Fluid Resuscitation in Adult Patients With Sepsis, Presenting as an Emergency to Hospital: ABC Sepsis Trial
The aim of this research study is to compare two different fluids (Human Albumin Solution (HAS) and Balanced Crystalloid that are given via a drip to patients with severe infection (sepsis). The investigators plan to see which fluid is better, and to see if they have a role in improving a patient's recovery time, reducing complications and the length of time they stay in hospital. This study plans to find out if there is evidence that one fluid is better overall to determine the need for a subsequent definitive trial.
Read the detailed description
This trial will be an open label two-arm, multicentre, pragmatic, parallel group randomised trial of adult patients with community acquired sepsis recruited from the Emergency Department and Medical and Surgical Assessment Units across ~10 UK NHS Hospitals. The treatment phase will be the first 6 hours following randomisation. 30-day and 90-day follow up will be conducted using routine data only. The exception to this will be the first 50 patients enrolled in the study, Health Related Quality of Life (HRQoL) will be measured using the EQ-5D-5L at baseline, 7 days and at 180 days. At baseline, the participant or their relative will be asked to recall the quality of life 4 weeks prior to the index hospital admission. Questionnaires will be administered by direct patient completion or, postal or email survey with telephone follow up for non-responders after two mailings two weeks apart.
- Conditions
- Sepsis
- Being tested
- Human albumin, Balanced crystalloid solution
- Keywords
- Sepsis, Emergency Care, Albumin, Crystalloid, Fluid, Resuscitation
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human albuminDrug
Any preparation of 5% Human Albumin Solution which has marketing authorisation in the UK to be used for this indication and is stocked by local hospital pharmacies at the participating sites, may be prescribed in this study
Balanced crystalloid solutionDrug
Any preparation of intravenous "balanced" crystalloid which has marketing authorisation in the UK to be used for this indication and is stocked by local hospital pharmacies at the participating sites, may be prescribed in this study.
| Study group | Role | What they receive |
|---|---|---|
| 5% Human Albumin Solution | Experimental | Participants allocated to the treatment arm will receive intravenous 5% Human Albumin Solution (HAS) administered as the sole intravenous fluid during the initial 6-hour resuscitation period. The clinician can deliver up to 10ml/kg in the first 3 hours using 250ml boluses of HAS based on clinical judgement, using clinical assessment supplemented by technology if that is their usual practice. This will be followed by repeat clinical assessment after each bolus (including vital signs; lactate testing). After 3 hours further HAS boluses up to 6 hours post-randomisation will be at clinical discretion and will be documented in the CRF. Patients in the albumin arm should not receive balanced crystalloid as a resuscitation fluid in the first 6 hours. Receives: Drug: Human albumin |
| Intravenous balanced crystalloid | Active comparator | Participant allocated to the usual care arm will receive intravenous balanced crystalloid administered as the sole intravenous fluid during the initial 6 hour resuscitation period. The clinician can deliver up to 30ml/kg in the first 3 hours using 250ml boluses of balanced crystalloid based on clinical judgement, using clinical assessment supplemented by technology if that is their usual practice. This will be followed by repeat clinical assessment after each bolus (including vital signs; lactate testing). Thereafter, further crystalloid boluses up to 6 hours will be at the discretion of the clinical team and will be documented in the CRF. Patients in the balanced crystalloid arm should not receive albumin as a resuscitation fluid in the first 6 hours. Receives: Drug: Balanced crystalloid solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
We measured the recruitment rate to assess deliverability. We aimed to recruit 300 participants in approximately 1 year in a 1:1 ratio into each treatment arm.
Measured: Approx 1 year
30-day Mortality
Assessment of how many participants in each arm died after 30 days to determine the effect size between the treatment groups.
Measured: 30 days
Secondary outcomes (22)
Data Completeness of Primary Outcome
Feasibility Outcome assessing the number of participants who provided data for clinical primary outcome (30 day mortality)
Measured: 180 days
Withdrawal From Study
Feasibility Outcomes assessing the number of participants who withdraw from study intervention and/or data collection
Measured: Approx 1 year
Number of Patients Who Receive Any Other Fluid Apart From Intervention or Control in First 6 Hrs After Recruitment
Feasibility Outcome- number of patients who receive any other fluid apart from intervention or control in first 6 hrs after recruitment
Measured: 6 hours
Time to Start of In-hospital Intravenous Fluids
Feasibility Outcome- Time to start of in-hospital intravenous fluids
Measured: From time of Randomisation until fluid first being administered measured up to 6 hours.
In-hospital Mortality
Secondary Clinical Outcome
Measured: From time of Randomisation until time of hospital discharge or death, whichever is first measured up to 90 days
90-day Mortality
Secondary Clinical Outcome
Measured: 90 days
Volume of Randomised Fluid Delivered in Each Arm in the First 6hrs
Secondary Clinical Outcome- Volume of randomised fluid delivered in each arm in the first 6hrs
Measured: 6 hours
Length of Hospital Stay
Secondary Clinical Outcome
Measured: 90 days
Proportion of Patients Admitted to Critical Care (HDU/ICU)
Secondary Clinical Outcome- Proportion of patients admitted to critical care (HDU/ICU)
Measured: 90 days
Length of Stay in Critical Care (HDU/ICU)
Secondary Clinical Outcome- Length of stay in critical care (HDU/ICU)
Measured: 90 days
Number of Participants Needing Intravenous Vasopressors
Secondary Clinical Outcome-number of participants needing intravenous vasopressors
Measured: From time of Randomisation until time of hospital discharge, measured up to 90 days.
Number of Participants Needing Renal Replacement
Secondary Clinical Outcome- Number of participants needing renal replacement
Measured: From time of Randomisation until time of hospital discharge, measured up to 90 days.
Number of Participants Needing Invasive Ventilation
Secondary Clinical Outcome- Number of participants needing invasive ventilation
Measured: From time of Randomisation until time of hospital discharge, measured up to 90 days.
Number of Patients Readmitted in First 90 Days After Discharge
Secondary Clinical Outcome- Number of patients readmitted in first 90 days after discharge
Measured: 90 days
Number of Patients Developing Acute Kidney Injury (AKI)
AKI Defined using National Institute for Health and Care Excellence (NICE) criteria:
A diagnosis of AKI may be made if there is one of the following:
A rise in serum creatinine of 26 micromol/L or greater within 48 hours. A 50% or greater rise in serum creatinine known or presumed to have occurred within the past 7 days.
A fall in urine output to less than 0.5 mL/kg/hour for more than 6 hours.
Measured: 7 days
Number of Patients Developing Pulmonary Oedema
Safety Radiology diagnosis or requirement for rescue management (new diuretic use)
Measured: 7 days
Number of Patients Developing Allergy or Anaphylaxis
Requirement for rescue management (antihistamines, adrenaline, intravenous fluids, steroid)
Measured: 7 days
Health Related Quality of Life (EQ-5D-5L Questionnaire)
Health Economic Outcomes are measured using the the 5-level EQ-5D version (EQ-5D-5L). The EQ-5D-5L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. A high score indicates a worse outcome. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. The digits for the five dimensions can be combined into a 5-digit number (profile) that describes the patient's health state. The EQ-5D profile can be converted to a single number between 0-1 called the EQ-5D value. These EQ-5D values to lie on between 0-1 to indicate health where 0 represents the minimum score (dead) and 1 is full health. Values less than 0 are possible for health states considered worse than dead.
Measured: baseline
Secondary Care Costs
Costs will be estimated by assigning national standard unit costs to inpatient stays (critical care and general ward level), readmissions and additional high costs activities observed in the study. Baseline (pre-admission) HQoL will be estimated using age/sex matched population reference data.
Measured: 30 days
Volume of Randomised Fluid Delivered in Each Arm in the First 24hrs
Secondary Clinical Outcome-Volume of randomised fluid delivered in each arm in the first 24hrs
Measured: 24 hours
Health Related Quality of Life (EQ-5D-5L Questionnaire)
Health Economic Outcomes are measured using the the 5-level EQ-5D version (EQ-5D-5L). The EQ-5D-5L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. A high score indicates a worse outcome. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. The digits for the five dimensions can be combined into a 5-digit number (profile) that describes the patient's health state. The EQ-5D profile can be converted to a single number between 0-1 called the EQ-5D value. These EQ-5D values to lie on between 0-1 to indicate health where 0 represents the minimum score (dead) and 1 is full health. Values less than 0 are possible for health states considered worse than dead.
Measured: 7 Days
Health Related Quality of Life (EQ-5D-5L Questionnaire)
Health Economic Outcomes are measured using the the 5-level EQ-5D version (EQ-5D-5L). The EQ-5D-5L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. A high score indicates a worse outcome. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. The digits for the five dimensions can be combined into a 5-digit number (profile) that describes the patient's health state. The EQ-5D profile can be converted to a single number between 0-1 called the EQ-5D value. These EQ-5D values to lie on between 0-1 to indicate health where 0 represents the minimum score (dead) and 1 is full health. Values less than 0 are possible for health states considered worse than dead.
Measured: 180 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start1 Jun 2021
- Primary completion12 Sep 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label two-arm, multicentre, pragmatic, parallel group randomised trial
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alasdair Gray, Study director, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540094
- Sponsor's protocol ID
- AC20043
- Acronym
- ABC Sepsis
- Status last verified
- Aug 2023
- First submitted
- 19 Aug 2020
- Last updated
- 4 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The intention is to share anonymised data with external collaborators and scientists one year after the primary publication has been published (anticipated Jun 2022).
Publications
Gray AJ, Oatey K, Grahamslaw J, Irvine S, Cafferkey J, Kennel T, Norrie J, Walsh T, Lone N, Horner D, Appelboam A, Hall P, Skipworth RJE, Bell D, Rooney K, Shankar-Hari M, Corfield AR; Albumin, Balanced, and Crystalloid-Sepsis (ABC-Sepsis) Investigators. Albumin Versus Balanced Crystalloid for the Early Resuscitation of Sepsis: An Open Parallel-Group Randomized Feasibility Trial- The ABC-Sepsis Trial. Crit Care Med. 2024 Oct 1;52(10):1520-1532. doi: 10.1097/CCM.0000000000006348. Epub 2024 Jun 24.
PubMed 38912884
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of 5% Albumin Compared With Balanced Crystalloid, as Intravenous Fluid Resuscitation in Adult Patients With Sepsis, Presenting as an Emergency to Hospital: ABC Sepsis Trial
- ClinicalTrials.gov ID
- NCT04540094
- Acronym / sponsor ID
- ABC Sepsis / AC20043
- Conditions
- Sepsis
- Keywords
- Sepsis, Emergency Care, Albumin, Crystalloid, Fluid, Resuscitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Posted 4 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this research study is to compare two different fluids (Human Albumin Solution (HAS) and Balanced Crystalloid that are given via a drip to patients with severe infection (sepsis). The investigators plan to see which fluid is better, and to see if they have a role in improving a patient's recovery time, reducing complications and the length of time they stay in hospital. This study plans to find out if there is evidence that one fluid is better overall to determine the need for a subsequent definitive trial.
Detailed description
This trial will be an open label two-arm, multicentre, pragmatic, parallel group randomised trial of adult patients with community acquired sepsis recruited from the Emergency Department and Medical and Surgical Assessment Units across ~10 UK NHS Hospitals. The treatment phase will be the first 6 hours following randomisation. 30-day and 90-day follow up will be conducted using routine data only. The exception to this will be the first 50 patients enrolled in the study, Health Related Quality of Life (HRQoL) will be measured using the EQ-5D-5L at baseline, 7 days and at 180 days. At baseline, the participant or their relative will be asked to recall the quality of life 4 weeks prior to the index hospital admission. Questionnaires will be administered by direct patient completion or, postal or email survey with telephone follow up for non-responders after two mailings two weeks apart.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label two-arm, multicentre, pragmatic, parallel group randomised trial
| Arm | Type | Receives |
|---|---|---|
| 5% Human Albumin Solution | Experimental | Drug: Human albuminParticipants allocated to the treatment arm will receive intravenous 5% Human Albumin Solution (HAS) administered as the sole intravenous fluid during the initial 6-hour resuscitation period. The clinician can deliver up to 10ml/kg in the first 3 hours using 250ml boluses of HAS based on clinical judgement, using clinical assessment supplemented by technology if that is their usual practice. This will be followed by repeat clinical assessment after each bolus (including vital signs; lactate testing). After 3 hours further HAS boluses up to 6 hours post-randomisation will be at clinical discretion and will be documented in the CRF. Patients in the albumin arm should not receive balanced crystalloid as a resuscitation fluid in the first 6 hours. |
| Intravenous balanced crystalloid | Active comparator | Drug: Balanced crystalloid solutionParticipant allocated to the usual care arm will receive intravenous balanced crystalloid administered as the sole intravenous fluid during the initial 6 hour resuscitation period. The clinician can deliver up to 30ml/kg in the first 3 hours using 250ml boluses of balanced crystalloid based on clinical judgement, using clinical assessment supplemented by technology if that is their usual practice. This will be followed by repeat clinical assessment after each bolus (including vital signs; lactate testing). Thereafter, further crystalloid boluses up to 6 hours will be at the discretion of the clinical team and will be documented in the CRF. Patients in the balanced crystalloid arm should not receive albumin as a resuscitation fluid in the first 6 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (18 years or older) who present to UK NHS hospitals with community acquired sepsis meeting all of the 4 criteria:
- Clinically suspected or proven infection resulting in principal reason for acute illness;
- NEWS score ≥5 (or NEWS2 if adopted in recruitment site);
- Hospital presentation within last 12hrs; and
- Clinician decision has been made that immediate (within 1 hour) intravenous fluid resuscitation is needed.
Key exclusion criteria (12 listed)
- >1 litre of intravenous crystalloid fluid or any intravenous HAS administered prior to eligibility assessment;
- Requirement for immediate surgery (within one hour of eligibility assessment);
- Chronic renal replacement therapy;
- Known allergy/adverse reaction to HAS;
- Balanced crystalloid or HAS not available;
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 |
|---|---|---|
| Human albuminAny preparation of 5% Human Albumin Solution which has marketing authorisation in the UK to be used for this indication and is stocked by local hospital pharmacies at the participating sites, may be prescribed in this study | Drug | 5% Human Albumin Solution |
| Balanced crystalloid solutionAny preparation of intravenous "balanced" crystalloid which has marketing authorisation in the UK to be used for this indication and is stocked by local hospital pharmacies at the participating sites, may be prescribed in this study. | Drug | Intravenous balanced crystalloid |
Primary outcome
Recruitment Rate
Time frame: Approx 1 year
We measured the recruitment rate to assess deliverability. We aimed to recruit 300 participants in approximately 1 year in a 1:1 ratio into each treatment arm.
30-day Mortality
Time frame: 30 days
Assessment of how many participants in each arm died after 30 days to determine the effect size between the treatment groups.
22 secondary outcomes
Data Completeness of Primary Outcome
Time frame: 180 days
Withdrawal From Study
Time frame: Approx 1 year
Number of Patients Who Receive Any Other Fluid Apart From Intervention or Control in First 6 Hrs After Recruitment
Time frame: 6 hours
Time to Start of In-hospital Intravenous Fluids
Time frame: From time of Randomisation until fluid first being administered measured up to 6 hours.
In-hospital Mortality
Time frame: From time of Randomisation until time of hospital discharge or death, whichever is first measured up to 90 days
90-day Mortality
Time frame: 90 days
Volume of Randomised Fluid Delivered in Each Arm in the First 6hrs
Time frame: 6 hours
Length of Hospital Stay
Time frame: 90 days
Proportion of Patients Admitted to Critical Care (HDU/ICU)
Time frame: 90 days
Length of Stay in Critical Care (HDU/ICU)
Time frame: 90 days
Number of Participants Needing Intravenous Vasopressors
Time frame: From time of Randomisation until time of hospital discharge, measured up to 90 days.
Number of Participants Needing Renal Replacement
Time frame: From time of Randomisation until time of hospital discharge, measured up to 90 days.
Number of Participants Needing Invasive Ventilation
Time frame: From time of Randomisation until time of hospital discharge, measured up to 90 days.
Number of Patients Readmitted in First 90 Days After Discharge
Time frame: 90 days
Number of Patients Developing Acute Kidney Injury (AKI)
Time frame: 7 days
Number of Patients Developing Pulmonary Oedema
Time frame: 7 days
Number of Patients Developing Allergy or Anaphylaxis
Time frame: 7 days
Health Related Quality of Life (EQ-5D-5L Questionnaire)
Time frame: baseline
Secondary Care Costs
Time frame: 30 days
Volume of Randomised Fluid Delivered in Each Arm in the First 24hrs
Time frame: 24 hours
Health Related Quality of Life (EQ-5D-5L Questionnaire)
Time frame: 7 Days
Health Related Quality of Life (EQ-5D-5L Questionnaire)
Time frame: 180 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38912884Gray AJ, Oatey K, Grahamslaw J, Irvine S, Cafferkey J, Kennel T, Norrie J, Walsh T, Lone N, Horner D, Appelboam A, Hall P, Skipworth RJE, Bell D, Rooney K, Shankar-Hari M, Corfield AR; Albumin, Balanced, and Crystalloid-Sepsis (ABC-Sepsis) Investigators. Albumin Versus Balanced Crystalloid for the Early Resuscitation of Sepsis: An Open Parallel-Group Randomized Feasibility Trial- The ABC-Sepsis Trial. Crit Care Med. 2024 Oct 1;52(10):1520-1532. doi: 10.1097/CCM.0000000000006348. Epub 2024 Jun 24.
- Individual participant dataSharing planned: Yes. The intention is to share anonymised data with external collaborators and scientists one year after the primary publication has been published (anticipated Jun 2022).
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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.
Alasdair Gray study director
University of Edinburgh
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Human albumin and Balanced crystalloid solution in people with Sepsis, run by University of Edinburgh at 15 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 12 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 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 4 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recruitment Rate (time frame: Approx 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04540094, which also lists 1 linked publication.
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 4 Oct 2024.