- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07562217
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)
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Hideaki Nonaka, Dr
- Numero di telefono: +61 449967910
- Email: hideaki54nonaka@gmail.com
Backup dei contatti dello studio
- Nome: Nonaka
Luoghi di studio
-
-
Queensland
-
Chermside, Queensland, Australia, 4032
- The Prince Charles Hospital
-
Contatto:
- Hideaki Nonaka, Dr
- Numero di telefono: +61 449967910
- Email: hideaki54nonaka@gmail.com
-
Contatto:
- Nonaka
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Suspected or confirmed pregnancy.
- Any severe concomitant diseases with limited life expectancy <30 days.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
Sepsis with hypotension or signs of hypoperfusion admitted to ICU
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
All cause death
Lasso di tempo: Day 30 after ICU admission
|
Day 30 after ICU admission
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
All cause death and adverse cardiac event readmission
Lasso di tempo: 1 year after ICU admission
|
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
Lasso di tempo: during the initial index admission, between Day 0 and Day 30
|
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
Lasso di tempo: Day 3 to Day 5
|
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
Lasso di tempo: at Day 3 of 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
lengh of hosiptal or ICU stay
Lasso di tempo: during the initial index admission, between Day 0 and Day 30
|
during the initial index admission, between Day 0 and Day 30
|
|
|
In-hospital mortariy
Lasso di tempo: during the initial index admission, between Day 0 and Day 30
|
during the initial index admission, between Day 0 and Day 30
|
|
|
Vasoactive-inotropic score at 24, and 48 hours
Lasso di tempo: at 24 hour and 48 hour of index ICU admission
|
at 24 hour and 48 hour of index ICU admission
|
|
|
Amount of fluid administered for the first 24 hours in ICU admission
Lasso di tempo: Day 1 of index ICU admission
|
CSL
|
Day 1 of index ICU admission
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Direttore dello studio: Hideaki Nonaka, Dr, The University of Queensland
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2025/PR011848
- INN2024-16 (Altro numero di sovvenzione/finanziamento: The Prince Charles Hospital Foundation (The Common Good))
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .