SepsisLIAISENCT07562217
Load Incorporating Cardiac Assessment by Echocardiography In Patients With SEpsis (LIAISE Study)
An observational study of Sepsis, run by The University of Queensland at 1 site in Australia.
Trial summary
The LIAISE study is a prospective observational study comparing the performance of load-incorporating echocardiographic parameters and conventional parameters in predicting adverse events among adult patients presenting to the ICU with sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 200 participants
- Where
- 1 siteAustralia
- Study dates
- 1 May 2026to 30 Nov 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with sepsis and hypotension / hypoperfusion signs, admitted for ICU
Who may be able to join
- Adults ≥ 18 years old.
- Clinically suspected of defined sepsis
- Sepsis-induced hypotension or hypoperfusion (arterial or venous blood lactate ≥2.0 mmol/L OR mean artery pressure ≤65 mmHg over 30 mins OR at least one vasoactive or inotropic agent administered).
- At least one dose of an IV antimicrobial has been commenced.
Who cannot join
- Suspected or confirmed pregnancy.
- Any severe concomitant diseases with limited life expectancy <30 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nonaka contact
Australia1 site
The Prince Charles Hospital
Chermside, Queensland, 4032
Hideaki Nonaka, Dr, +61 449967910, hideaki54nonaka@gmail.com
Nonaka
About this study
Official title: Load Incorporating Cardiac Assessment by Echocardiography In Patients With SEpsis: a Prospective Observational Study (LIAISE Study)
The LIAISE study is a prospective observational study comparing the performance of load-incorporating echocardiographic parameters and conventional parameters in predicting adverse events among adult patients presenting to the ICU with sepsis. It will be conducted in hospitals in Australia, Hong Kong, South Africa, and Canada, with 199 patients recruited over 2 years. All included patients will receive an regular echocardiographic assessment and their haemodynamic parameters will be simultaneously recorded. Participants will be followed for up to 1 year after enrolment. Load incorporating parameters will be derived from regularly obtained echocardiography and haemodynamic data during offline analysis. The predictive value of cardiac parameters will be evaluated based on their statistical association with clinical outcomes.
Read the detailed description
Background Sepsis is a global killer, whereby an infection spreads throughout the body via the bloodstream. It often leads to lethal heart damage, "septic cardiomyopathy", with mortality rates for those affected soaring above 40%. To facilitate early and appropriate intervention for damaged hearts and improve their outcomes, accurate assessment of heart function, and proper prediction of their adverse events are crucial. However, conventional cardiac assessments cannot capture heart dysfunction accurately since they have a significant limitation called "load-dependency", which means these parameters' values are affected by loading conditions on the heart, such as blood pressure and circulating blood volume. In sepsis, as these loads on the heart dramatically change minute by minute, the values of cardiac assessment also fluctuate and frequently underestimates heart damage, failing to properly predict their adverse events. To address this, novel load-incorporating echocardiographic parameters can capture heart function more accurately regardless of these hemodynamic conditions, and previous data has demonstrated its better predictive value in cardiogenic shock cases where loading conditions similarly fluctuate. As a next step, this study seeks to elucidate their utility in patients with sepsis.
Aims
- To investigate if novel load-incorporating echocardiography can predict adverse events more accurately than conventional parameters in adult patients with sepsis presenting to intensive care units (ICUs).
- To identify the most sensitive cardiac parameter to predict adverse events in sepsis, from comprehensively collected cardiac parameters along with novel-incorporating echocardiography.
Hypothesis Load-incorporating echocardiographic parameters will be more accurate in predicting the incidence of adverse events within 30 days after ICU admission than conventional echocardiographic parameters.
Outcomes Primary outcome The incidence of all-cause death for 30 days after ICU admission
Secondary outcomes
- Incidence of and time to all-cause death or cardiovascular readmission for 1 year after ICU admission
- Incidence and duration of mechanical circulatory support, mechanical ventilation, renal replacement therapy, and vasoactive agent therapy during initial admission.
- Reversibility of cardiac function (LVEF increases ≥ 5% in echo 3-5 days after ICU admission)
- Sequential Organ Failure Assessment (SOFA) score at 3 days after ICU admission
- Conditions
- Sepsis
- Keywords
- sepsis, echocardiography, strain, speckle-tracking, myocardial work, ICU, echocardiogram, load-independent
- Medical subject headings
- Sepsis, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis with hypotension or signs of hypoperfusion admitted to ICU | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause death
Measured: Day 30 after ICU admission
Secondary outcomes (4)
All cause death and adverse cardiac event readmission
Incidence of and time to all-cause death or adverse cardiac event readmissions for 1 year after ICU admission
Measured: 1 year after ICU admission
Mechanical circulartory suport, mechanical ventilation, renal replacement therapy, and vasoactive/inotropic agent therapy
Incidence and duration (days) of mechanical circulatory support, mechanical ventilation, renal replacement therapy, and vasoactive agent therapy during initial admission
Measured: during the initial index admission, between Day 0 and Day 30
Reversibility of cardiac function
Left ventricular ejection fraction increases ≥ 5% in echo from 3-5 days after ICU admission
Measured: Day 3 to Day 5
Sequential Organ Failure Assessment score at 3 days after ICU admission
Sequential Organ Failure Assessment score at Day 3 of index ICU admission will be assessed on a scale from 0 to 24, with higher scores indicating more severe organ failure.
Measured: at Day 3 of ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Responsible party
- Sponsor
- Investigators
- Hideaki Nonaka, Dr, Study director, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562217
- Sponsor's protocol ID
- 2025/PR011848
- Other IDs
- INN2024-16
- Acronym
- LIAISE
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol Statistical Analysis Plan Informed Consent Form
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Load Incorporating Cardiac Assessment by Echocardiography In Patients With SEpsis: a Prospective Observational Study (LIAISE Study)
- ClinicalTrials.gov ID
- NCT07562217
- Acronym / sponsor ID
- LIAISE / 2025/PR011848
- Conditions
- Sepsis
- Keywords
- sepsis, echocardiography, strain, speckle-tracking, myocardial work, ICU, echocardiogram, load-independent
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 1 May 2026 (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 LIAISE study is a prospective observational study comparing the performance of load-incorporating echocardiographic parameters and conventional parameters in predicting adverse events among adult patients presenting to the ICU with sepsis. It will be conducted in hospitals in Australia, Hong Kong, South Africa, and Canada, with 199 patients recruited over 2 years. All included patients will receive an regular echocardiographic assessment and their haemodynamic parameters will be simultaneously recorded. Participants will be followed for up to 1 year after enrolment. Load incorporating parameters will be derived from regularly obtained echocardiography and haemodynamic data during offline analysis. The predictive value of cardiac parameters will be evaluated based on their statistical association with clinical outcomes.
Detailed description
Background Sepsis is a global killer, whereby an infection spreads throughout the body via the bloodstream. It often leads to lethal heart damage, "septic cardiomyopathy", with mortality rates for those affected soaring above 40%. To facilitate early and appropriate intervention for damaged hearts and improve their outcomes, accurate assessment of heart function, and proper prediction of their adverse events are crucial. However, conventional cardiac assessments cannot capture heart dysfunction accurately since they have a significant limitation called "load-dependency", which means these parameters' values are affected by loading conditions on the heart, such as blood pressure and circulating blood volume. In sepsis, as these loads on the heart dramatically change minute by minute, the values of cardiac assessment also fluctuate and frequently underestimates heart damage, failing to properly predict their adverse events. To address this, novel load-incorporating echocardiographic parameters can capture heart function more accurately regardless of these hemodynamic conditions, and previous data has demonstrated its better predictive value in cardiogenic shock cases where loading conditions similarly fluctuate. As a next step, this study seeks to elucidate their utility in patients with sepsis.
Aims
- To investigate if novel load-incorporating echocardiography can predict adverse events more accurately than conventional parameters in adult patients with sepsis presenting to intensive care units (ICUs).
- To identify the most sensitive cardiac parameter to predict adverse events in sepsis, from comprehensively collected cardiac parameters along with novel-incorporating echocardiography.
Hypothesis Load-incorporating echocardiographic parameters will be more accurate in predicting the incidence of adverse events within 30 days after ICU admission than conventional echocardiographic parameters.
Outcomes Primary outcome The incidence of all-cause death for 30 days after ICU admission
Secondary outcomes
- Incidence of and time to all-cause death or cardiovascular readmission for 1 year after ICU admission
- Incidence and duration of mechanical circulatory support, mechanical ventilation, renal replacement therapy, and vasoactive agent therapy during initial admission.
- Reversibility of cardiac function (LVEF increases ≥ 5% in echo 3-5 days after ICU admission)
- Sequential Organ Failure Assessment (SOFA) score at 3 days after ICU admission
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sepsis with hypotension or signs of hypoperfusion admitted to ICU | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sepsis and hypotension / hypoperfusion signs, admitted for ICU
Key inclusion criteria (4 listed)
- Adults ≥ 18 years old.
- Clinically suspected of defined sepsis
- Sepsis-induced hypotension or hypoperfusion (arterial or venous blood lactate ≥2.0 mmol/L OR mean artery pressure ≤65 mmHg over 30 mins OR at least one vasoactive or inotropic agent administered).
- At least one dose of an IV antimicrobial has been commenced.
Key exclusion criteria (2 listed)
- Suspected or confirmed pregnancy.
- Any severe concomitant diseases with limited life expectancy <30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All cause death
Time frame: Day 30 after ICU admission
4 secondary outcomes
All cause death and adverse cardiac event readmission
Time frame: 1 year after ICU admission
Mechanical circulartory suport, mechanical ventilation, renal replacement therapy, and vasoactive/inotropic agent therapy
Time frame: during the initial index admission, between Day 0 and Day 30
Reversibility of cardiac function
Time frame: Day 3 to Day 5
Sequential Organ Failure Assessment score at 3 days after ICU admission
Time frame: at Day 3 of ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. Study Protocol Statistical Analysis Plan Informed Consent Form
Related trials for Sepsis
Not yet recruitingPhase 2/3
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A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Active, not recruitingPhase 4
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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.
Nonaka contact
Hideaki Nonaka, Dr study director
The University of Queensland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by The University of Queensland at 1 site in Australia.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 1 May 2026. 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 Australia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hideaki Nonaka, Dr (+61 449967910, hideaki54nonaka@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause death (time frame: Day 30 after ICU admission). 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 1 May 2026.