Acute Cardiac Dysfunction in Critical Illnes

Sponsor
Sahlgrenska University Hospital, Sweden (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05860504
Collaborator
(none)
592
39.5

Study Details

Study Description

Brief Summary

The overall aim of the study is to establish the clinical importance of cardiac dysfunction, by estimating its incidence and impact on short- and long-term outcomes, in a mixed population of critically ill patients with multi-organ failure. Pathogenesis of cardiac dysfunction in critical illness and key molecules linked to this will be explored.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Echocardiography
  • Diagnostic Test: Cardiac magnetic resonance imaging
  • Diagnostic Test: Coronary CT

Detailed Description

During critical illness, the heart is exposed to extreme external stressors, which may contribute to heart failure. There is a lack of knowledge of what happens to the heart over the course of critical illness. The few studies available suggest that LV dysfunction is common in critical illness, with a prevalence of 10-30%. Notably, LV regional hypokinesia is a frequent pattern of LV dysfunction among these patients and is associated with a higher risk of death.

LV regional hypokinesia during critical illness may have several possible aetiologies, including ischemic, inflammatory or other/mixed processes. Of these, acute coronary artery obstruction is probably most important. Patients with sepsis, for example, and acute ST elevation myocardial infarction have twice the risk of death. Type II myocardial infarction can also lead to LV dysfunction due to insufficient coronary artery flow e.g., from tachycardia, hypotension and hypoxia, resulting in myocardial ischemia. In the absence of CAD, LV regional hypokinesia could also result from myocardial inflammation secondary to systemic inflammatory response, direct toxic effects of cytokines or pathogenic infiltration. Another possible aetiology is Takotsubo syndrome, an acute cardiac condition characterised by reversible regional hypokinesia, usually in the apical portion of the LV. The current paradigm suggests that Takotsubo syndrome is triggered by the overstimulation of the myocardium by catecholamines and is closely correlated to events involving severe emotional or physical stress. Cardiac dysfunction in critical illness is likely a phenotype of Takotsubo syndrome since patients in the ICU undergo extreme stress and are exposed to both endogenously-released and exogenously-administered catecholamines.

In critical illness, accurate diagnosis of LV dysfunction is challenging due to the similar clinical presentation of potential aetiologies. However, diagnosing the underlying aetiology of LV dysfunction is essential to provide appropriate treatment and optimise outcomes. CAD can be diagnosed with coronary angiography and cardiac computed tomography (CCT). In the absence of CAD, cMRI is useful. cMRI can differentiate between myocardial ischemia, and inflammation, as well as between an acute or past event.

In this study, patients are examined with echocardiography to identify those with cardiac dysfunction. In a sub-set of patients with LV dysfunction, patients will be examined with coronary CT (if no angiography performed) and cardiac MRI. Blood samples are collected for storage in biobank.

Study Design

Study Type:
Observational
Anticipated Enrollment :
592 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Aetiology and Clinical Importance of Acute Cardiac Dysfunction in Critical Illness
Anticipated Study Start Date :
May 15, 2023
Anticipated Primary Completion Date :
May 15, 2026
Anticipated Study Completion Date :
Aug 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Normal left ventricular systolic function

Patients with normal echocardiographic systolic function, defined as having left ventricular ejection fraction ≥ 50% and no regional hypokinesia

Diagnostic Test: Echocardiography
All patients in the study will be examined with echocardiography

Left ventricular dysfunction

Patients with echocardiographic left ventricular systolic dysfunction, defines as having left ventricular ejection fraction < 50% or left ventricular regional hypokinesia in at least two adjacent segments

Diagnostic Test: Echocardiography
All patients in the study will be examined with echocardiography

Diagnostic Test: Cardiac magnetic resonance imaging
Sub-group of patients with left ventricular systolic dysfunction will be examined with cMRI
Other Names:
  • cMRI
  • Diagnostic Test: Coronary CT
    Sub-group of patients with left ventricular systolic dysfunction will be examined with CCT
    Other Names:
  • CCT
  • Outcome Measures

    Primary Outcome Measures

    1. 90-days mortality [90 days]

      Death

    Secondary Outcome Measures

    1. Alive outside ICU [90 days]

      Days alive while not in the ICU

    2. Alive without mechanical ventilation [90 days]

      Days alive and without mechanical ventilation

    3. Alive without CRRT [90 days]

      Days alive without CRRT

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Patients aged > 18 years

    2. Admitted to a participating ICU within 24 hours

    3. Significant organ dysfunction involving at least two organ systems. This is defined as fulfilling both of the following:

    • At least 4 points on the SOFA scale (Sequential Organ Failure Assessment scale)

    • Having at least 1 point on the SOFA scale from at least two organ systems

    1. Given informed consent from patient or permission to participate from next of kin
    Exclusion Criteria:
    1. Echocardiographic examination not possible (e.g., pneumothorax, draping etc) or very low echocardiographic examination quality

    2. Not being examined with echocardiography within 24 hours from inclusion

    3. Retracted consent to participate

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sahlgrenska University Hospital, Sweden

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonatan Oras, Associate professor/Senior consultant, Sahlgrenska University Hospital, Sweden
    ClinicalTrials.gov Identifier:
    NCT05860504
    Other Study ID Numbers:
    • SCCCS
    First Posted:
    May 16, 2023
    Last Update Posted:
    May 18, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 18, 2023