Load Incorporating Cardiac Assessment by Echocardiography In Patients With SEpsis (LIAISE Study) (LIAISE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis

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

1. 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).
2. 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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Hideaki Nonaka, Dr; Phone Number: +61 449967910; Email: hideaki54nonaka@gmail.com
• Study Contact Backup: Name: Nonaka

Study Locations

• Australia
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • The Prince Charles Hospital
      • Contact: Hideaki Nonaka, Dr; Phone Number: +61 449967910; Email: hideaki54nonaka@gmail.com
      • Contact: Nonaka

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with sepsis and hypotension / hypoperfusion signs, admitted for ICU

Description

Inclusion Criteria:

1. Adults ≥ 18 years old.
2. Clinically suspected of defined sepsis
3. 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).
4. At least one dose of an IV antimicrobial has been commenced.

Exclusion Criteria:

1. Suspected or confirmed pregnancy.
2. Any severe concomitant diseases with limited life expectancy <30 days.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Sepsis with hypotension or signs of hypoperfusion admitted to ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All cause death	Day 30 after ICU admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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.	at Day 3 of ICU admission

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
lengh of hosiptal or ICU stay		during the initial index admission, between Day 0 and Day 30
In-hospital mortariy		during the initial index admission, between Day 0 and Day 30
Vasoactive-inotropic score at 24, and 48 hours		at 24 hour and 48 hour of index ICU admission
Amount of fluid administered for the first 24 hours in ICU admission	CSL	Day 1 of index ICU admission

Collaborators and Investigators

• Sponsor: The University of Queensland
• Collaborators: Queen Mary Hospital, Hong Kong
• Investigators: Study Director: Hideaki Nonaka, Dr, The University of Queensland

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: April 25, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: ICU; echocardiography; sepsis; echocardiogram; strain; myocardial work; speckle-tracking; load-independent
• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis; Sprains and Strains
• Other Study ID Numbers: 2025/PR011848; INN2024-16 (Other Grant/Funding Number: The Prince Charles Hospital Foundation (The Common Good))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Protocol Statistical Analysis Plan Informed Consent Form
• IPD Sharing Time Frame: Start date: January 2025 End date: December 2027
• IPD Sharing Access Criteria: PRS access holders
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No