Sepsis, SevereNCT05357339
Microcirculation Properties of Albumin for Fluid Resuscitation in Septic Shock
A study testing 20% Albumin and Crystalloid in people with Sepsis, Severe and Sepsis, run by Rachael Cusack at 1 site in Ireland.
Trial summary
The sublingual microcirculation is impaired in sepsis and septic shock. Sidestream dark field imaging technology has been developed into a clinical tool to help the clinician assess the microcirculation at the bedside. The ideal resuscitation fluid has not been identified. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Severe, Sepsis, Septic Shock
- What is being tested?
- 20% Albumin and Crystalloid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 1 Sep 2021to 1 Dec 2023
- Phase
- Interventional
- 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
- Sepsis; suspected source of infection, tachycardia, tachypneic, hyperlactatemia, hypotensive requiring vasopressors, febrile >38.5degrees Celsius
- Fluid responsive; pulse pressure variability >10% or passive leg raise positive
Who cannot join
- Fluid overloaded; pulmonary oedema, significant peripheral oedema
- Heart Failure, cardiogenic shock, recent MI
- Receiving regular albumin 20%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Fluid Resuscitation with 20% Albumin Versus Crystalloid on the Microcirculation of Patients with Sepsis
The sublingual microcirculation is impaired in sepsis and septic shock. Sidestream dark field imaging technology has been developed into a clinical tool to help the clinician assess the microcirculation at the bedside. The ideal resuscitation fluid has not been identified. The investigators aim to use this new bedside technology to establish the microcirculation properties of two popular resuscitation fluids.
Read the detailed description
Sepsis and septic shock are diseases of the microcirculation. Recent developments in microcirculation imaging have illustrated the extent of the impairment of the microcirculation in these diseases of critical care. Heterogenous flow, stagnation and microthrombi can all be seen clearly in the sublingual region using a sidestream dark field imaging device.
One of the key treatments for sepsis and septic shock is timely administration of intravenous fluids. Which fluid is administered is a matter for debate which has not been settled by several large trials. De-resuscitation has become increasingly important as physicians realise the implications and associated risks of excess fluid administration in ICU. Avoiding excess fluid administration at the resuscitation stage is therefore desirable. One of the prevailing theories about the function of albumin or colloid resuscitation is that it remains in the the intravascular space for a longer period of time, thereby continuing to benefit the patient and avoiding administration of excess fluid. However, recently albumin was tested against crystalloid for resuscitation and was shown to be effective but with no improvement in survival.
It is possible, however, that albumin is having an initial beneficial effect at a microcirculation level. Macrohaemodynamic improvements are not necessarily matched by improvements in blood flow and oxygen delivery to cells, this has been referred to as haemodynamic incoherence.
This randomised, prospective study aims to compare crystalloid and albumin resuscitation at a microcirculation level.
- Conditions
- Sepsis, Severe, Sepsis, Septic Shock
- Being tested
- 20% Albumin, Crystalloid
- Keywords
- microcirculation, sidestream dark field
- 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.
20% AlbuminOther
100ml boluses 20% Albumin
CrystalloidOther
100ml bolus of crystalloid
| Study group | Role | What they receive |
|---|---|---|
| Interventional 20% Albumin | Experimental | Septic patients requiring a fluid bolus randomised to receive 100ml 20% albumin as boluses until they are stable or no longer require fluid resuscitation. Receives: Other: 20% Albumin |
| Control Crystalloid | Active comparator | Septic patients requiring a fluid bolus randomised to receive 250ml boluses of crystalloid fluid until they no longer require fluid resuscitation. Receives: Other: Crystalloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Microcirculation parameters in response to a fluid bolus
functional capillary density, perfused capillary density after fluid bolus Proportion Perfused vessels Microvascular Flow Index Total Vessel Density
Measured: Baseline at recruitment before fluid given, during bolus, after bolus: immediately after, 60 minutes after and 24 hours after to determine if immediate, delayed or sustained change in microcirculation parameters is influenced by fluid bolus
Secondary outcomes (4)
Duration of vasopressor administration
Measured: 28 days
Duration of Mechanical ventilation
Measured: 28 days
ICU length of stay
Measured: though to stud completion; up to 1 year
28 day mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Sep 2021
- Primary completion10 Jul 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sepsis, SevereStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rachael Cusack
- Sponsor type
- University, hospital or other
- Collaborators
- Grifols Biologicals, LLC
- Responsible party
- Sponsor-investigator, Rachael Cusack, St. James's Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357339
- Sponsor's protocol ID
- MICALB21
- Status last verified
- Oct 2024
- First submitted
- 19 Jan 2022
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cusack R, Garduno A, Cumpf S, Reyes-Morales P, Leone M, Fernandez AB, Rodriguez A, Martin-Loeches I. Mid-Regional Pro-Adrenomedullin as a Translational Biomarker of Microcirculatory Dysfunction in Sepsis: A Prospective Observational Study. Med Sci (Basel). 2026 Mar 2;14(1):117. doi: 10.3390/medsci14010117.
PubMed 41892832Cusack R, Rodriguez A, Cantan B, Miskolci O, Connolly E, Zilahi G, Coakley JD, Martin-Loeches I. Albumin Enhances Microvascular Reactivity in Sepsis: Insights from Near-Infrared Spectroscopy and Vascular Occlusion Testing. J Clin Med. 2025 Jul 14;14(14):4982. doi: 10.3390/jcm14144982.
PubMed 40725675Cusack RAF, Rodriguez A, Cantan B, Garduno A, Connolly E, Zilahi G, Coakley JD, Martin-Loeches I. Microcirculation properties of 20 % albumin in sepsis; a randomised controlled trial. J Crit Care. 2025 Jun;87:155039. doi: 10.1016/j.jcrc.2025.155039. Epub 2025 Feb 27.
PubMed 40020556
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fluid Resuscitation with 20% Albumin Versus Crystalloid on the Microcirculation of Patients with Sepsis
- ClinicalTrials.gov ID
- NCT05357339
- Acronym / sponsor ID
- MICALB21
- Conditions
- Sepsis, Severe, Sepsis, Septic Shock
- Keywords
- microcirculation, sidestream dark field
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rachael CusackUniversity, hospital or other
- Collaborators
- Grifols Biologicals, LLC
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 2 May 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.
The sublingual microcirculation is impaired in sepsis and septic shock. Sidestream dark field imaging technology has been developed into a clinical tool to help the clinician assess the microcirculation at the bedside. The ideal resuscitation fluid has not been identified. The investigators aim to use this new bedside technology to establish the microcirculation properties of two popular resuscitation fluids.
Detailed description
Sepsis and septic shock are diseases of the microcirculation. Recent developments in microcirculation imaging have illustrated the extent of the impairment of the microcirculation in these diseases of critical care. Heterogenous flow, stagnation and microthrombi can all be seen clearly in the sublingual region using a sidestream dark field imaging device.
One of the key treatments for sepsis and septic shock is timely administration of intravenous fluids. Which fluid is administered is a matter for debate which has not been settled by several large trials. De-resuscitation has become increasingly important as physicians realise the implications and associated risks of excess fluid administration in ICU. Avoiding excess fluid administration at the resuscitation stage is therefore desirable. One of the prevailing theories about the function of albumin or colloid resuscitation is that it remains in the the intravascular space for a longer period of time, thereby continuing to benefit the patient and avoiding administration of excess fluid. However, recently albumin was tested against crystalloid for resuscitation and was shown to be effective but with no improvement in survival.
It is possible, however, that albumin is having an initial beneficial effect at a microcirculation level. Macrohaemodynamic improvements are not necessarily matched by improvements in blood flow and oxygen delivery to cells, this has been referred to as haemodynamic incoherence.
This randomised, prospective study aims to compare crystalloid and albumin resuscitation at a microcirculation level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional 20% Albumin | Experimental | Other: 20% AlbuminSeptic patients requiring a fluid bolus randomised to receive 100ml 20% albumin as boluses until they are stable or no longer require fluid resuscitation. |
| Control Crystalloid | Active comparator | Other: CrystalloidSeptic patients requiring a fluid bolus randomised to receive 250ml boluses of crystalloid fluid until they no longer require fluid resuscitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sepsis; suspected source of infection, tachycardia, tachypneic, hyperlactatemia, hypotensive requiring vasopressors, febrile >38.5degrees Celsius
- Fluid responsive; pulse pressure variability >10% or passive leg raise positive
Key exclusion criteria (3 listed)
- Fluid overloaded; pulmonary oedema, significant peripheral oedema
- Heart Failure, cardiogenic shock, recent MI
- Receiving regular albumin 20%
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 |
|---|---|---|
| 20% Albumin100ml boluses 20% Albumin | Other | Interventional 20% Albumin |
| Crystalloid100ml bolus of crystalloid | Other | Control Crystalloid |
Primary outcome
Change in Microcirculation parameters in response to a fluid bolus
Time frame: Baseline at recruitment before fluid given, during bolus, after bolus: immediately after, 60 minutes after and 24 hours after to determine if immediate, delayed or sustained change in microcirculation parameters is influenced by fluid bolus
functional capillary density, perfused capillary density after fluid bolus Proportion Perfused vessels Microvascular Flow Index Total Vessel Density
4 secondary outcomes
Duration of vasopressor administration
Time frame: 28 days
Duration of Mechanical ventilation
Time frame: 28 days
ICU length of stay
Time frame: though to stud completion; up to 1 year
28 day mortality
Time frame: 28 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 26 Oct 2024.
- Derived from this study: PubMed 41892832Cusack R, Garduno A, Cumpf S, Reyes-Morales P, Leone M, Fernandez AB, Rodriguez A, Martin-Loeches I. Mid-Regional Pro-Adrenomedullin as a Translational Biomarker of Microcirculatory Dysfunction in Sepsis: A Prospective Observational Study. Med Sci (Basel). 2026 Mar 2;14(1):117. doi: 10.3390/medsci14010117.
- Derived from this study: PubMed 40725675Cusack R, Rodriguez A, Cantan B, Miskolci O, Connolly E, Zilahi G, Coakley JD, Martin-Loeches I. Albumin Enhances Microvascular Reactivity in Sepsis: Insights from Near-Infrared Spectroscopy and Vascular Occlusion Testing. J Clin Med. 2025 Jul 14;14(14):4982. doi: 10.3390/jcm14144982.
- Derived from this study: PubMed 40020556Cusack RAF, Rodriguez A, Cantan B, Garduno A, Connolly E, Zilahi G, Coakley JD, Martin-Loeches I. Microcirculation properties of 20 % albumin in sepsis; a randomised controlled trial. J Crit Care. 2025 Jun;87:155039. doi: 10.1016/j.jcrc.2025.155039. Epub 2025 Feb 27.
- Individual participant dataSharing planned: No
Related trials for Sepsis, Severe
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
Hypertensive Disorder of Pregnancy, Preeclampsia
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
Recruiting
Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock
Septic Shock, Methylene Blue
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20% Albumin and Crystalloid in people with Sepsis, Severe and Sepsis, run by Rachael Cusack at 1 site in Ireland.
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 2 inclusion and 3 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 26 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 1 site in Ireland. 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.
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?
Change in Microcirculation parameters in response to a fluid bolus (time frame: Baseline at recruitment before fluid given, during bolus, after bolus: immediately after, 60 minutes after and 24 hours after to determine if immediate, delayed or sustained change in microcirculation parameters is influenced by fluid bolus). 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 NCT05357339, which also lists 3 linked publications.
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 26 Oct 2024.