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

NCT07562217 | Not Yet Recruiting DMC

• 2 other identifiers: 2025/PR011848INN2024-16
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sepsis

Keywords

sepsis; echocardiography; strain; speckle-tracking; myocardial work; ICU; echocardiogram; load-independent

Outcome Measures

Primary Outcomes (1)

• All cause death

  Day 30 after ICU admission

Secondary Outcomes (4)

• All cause death and adverse cardiac event readmission

  1 year after ICU admission

• Mechanical circulartory suport, mechanical ventilation, renal replacement therapy, and vasoactive/inotropic agent therapy

  during the initial index admission, between Day 0 and Day 30

• Reversibility of cardiac function

  Day 3 to Day 5

• Sequential Organ Failure Assessment score at 3 days after ICU admission

  at Day 3 of ICU admission

Other Outcomes (4)

• 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

Study Arms (1)

Sepsis with hypotension or signs of hypoperfusion admitted to ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The University of Queensland: lead
• Queen Mary Hospital, Hong Kong: collaborator

Study Sites (1)

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

MeSH Terms

Conditions

Sepsis; Sprains and Strains

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Hideaki Nonaka, Dr

  The University of Queensland

  STUDY DIRECTOR

Central Study Contacts

Hideaki Nonaka, Dr

CONTACT

+61 449967910; hideaki54nonaka@gmail.com

Nonaka

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: May 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): November 30, 2028
• Last Updated: May 1, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Start date: January 2025 End date: December 2027
• Access Criteria: PRS access holders

Locations

AU (1)