An observational study in Multi Organ Failure, Left Ventricular Dysfunction and Right Ventricular Dysfunction, sponsored by Sahlgrenska University Hospital. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-06.
Sponsored by Sahlgrenska University Hospital · Observational
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.
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.
193 studies on the registry are indexed under Multiple Organ Failure; 47 are open to participants now.
This study's planned enrollment of 592 is above the median of 200 across 94 observational studies indexed under Multiple Organ Failure.
Browse Multiple Organ Failure studies →Sahlgrenska University Hospital is the lead sponsor of 263 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with significant multi-organ dysfunction being admitted to a participaing ICU within 24 hours
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Significant organ dysfunction involving at least two organ systems. This is defined as fulfilling both of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with normal echocardiographic systolic function, defined as having left ventricular ejection fraction ≥ 50% and no regional hypokinesia
Diagnostic Test: Echocardiography
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 · Diagnostic Test: Cardiac magnetic resonance imaging · Diagnostic Test: Coronary CT
All patients in the study will be examined with echocardiography
Sub-group of patients with left ventricular systolic dysfunction will be examined with cMRI
Also known as: cMRI
Sub-group of patients with left ventricular systolic dysfunction will be examined with CCT
Also known as: CCT
90-days mortality
Death
Time frame: 90 days
Alive outside ICU
Days alive while not in the ICU
Time frame: 90 days
Alive without mechanical ventilation
Days alive and without mechanical ventilation
Time frame: 90 days
Alive without CRRT
Days alive without CRRT
Time frame: 90 days
Started May 2023 (actual). Primary completion is estimated for Dec 2025, 31 months after the start.
Of 44 non-industry observational studies under Multiple Organ Failure, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's planned 31 months is close to that.
Counting every sponsor, half of 44 studies reached it within 32 months; a quarter within 16 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
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