Multi Organ FailureNCT05860504
Acute Cardiac Dysfunction in Critical Illnes
An observational study of Multi Organ Failure and Left Ventricular Dysfunction, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multi Organ Failure, Left Ventricular Dysfunction, Right Ventricular Dysfunction
- What is being tested?
- Echocardiography, Cardiac magnetic resonance imaging and Coronary CT
- How many people
- 592 participants
- Where
- 1 siteSweden
- Study dates
- 29 May 2023to 30 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with significant multi-organ dysfunction being admitted to a participaing ICU within 24 hours
Who may be able to join
- Patients aged > 18 years
- Admitted to a participating ICU within 24 hours
- 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
- Given informed consent from patient or permission to participate from next of kin
Who cannot join
- Echocardiographic examination not possible (e.g., pneumothorax, draping etc) or very low echocardiographic examination quality
- Not being examined with echocardiography within 24 hours from inclusion
- Retracted consent to participate
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Sahgrensak University Hospital
Västra Frölunda, Please Select, 42668
Jacob Holmqvist, MD, jacob.holmqvist@vgregion.se
About this study
Official title: Aetiology and Clinical Importance of Acute Cardiac Dysfunction in Critical Illness
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.
Read the 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.
- Conditions
- Multi Organ Failure, Left Ventricular Dysfunction, Right Ventricular Dysfunction, Tako Tsubo Cardiomyopathy, Myocardial Infarction, Cardiomyopathy, Stress
- Being tested
- Echocardiography, Cardiac magnetic resonance imaging, Coronary CT
- Medical subject headings
- Multiple Organ Failure, Ventricular Dysfunction, Left, Ventricular Dysfunction, Right, Takotsubo Cardiomyopathy, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
All patients in the study will be examined with echocardiography
Cardiac magnetic resonance imagingDiagnostic test
Also called cMRI
Sub-group of patients with left ventricular systolic dysfunction will be examined with cMRI
Coronary CTDiagnostic test
Also called CCT
Sub-group of patients with left ventricular systolic dysfunction will be examined with CCT
| Study group | Role | What they receive |
|---|---|---|
| Normal left ventricular systolic function | Patients with normal echocardiographic systolic function, defined as having left ventricular ejection fraction ≥ 50% and no regional hypokinesia Receives: Diagnostic Test: 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 Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Cardiac magnetic resonance imaging; Diagnostic Test: Coronary CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-days mortality
Death
Measured: 90 days
Secondary outcomes (3)
Alive outside ICU
Days alive while not in the ICU
Measured: 90 days
Alive without mechanical ventilation
Days alive and without mechanical ventilation
Measured: 90 days
Alive without CRRT
Days alive without CRRT
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start29 May 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi Organ FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 592 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonatan Oras, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860504
- Sponsor's protocol ID
- SCCCS
- Status last verified
- Oct 2023
- First submitted
- 8 May 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aetiology and Clinical Importance of Acute Cardiac Dysfunction in Critical Illness
- ClinicalTrials.gov ID
- NCT05860504
- Acronym / sponsor ID
- SCCCS
- Conditions
- Multi Organ Failure, Left Ventricular Dysfunction, Right Ventricular Dysfunction, Tako Tsubo Cardiomyopathy, Myocardial Infarction, Cardiomyopathy, Stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 592 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal left ventricular systolic function | – | Diagnostic Test: EchocardiographyPatients with normal echocardiographic systolic function, defined as having left ventricular ejection fraction ≥ 50% and no regional hypokinesia |
| Left ventricular dysfunction | – | Diagnostic Test: Echocardiography, Diagnostic Test: Cardiac magnetic resonance imaging, Diagnostic Test: Coronary CTPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with significant multi-organ dysfunction being admitted to a participaing ICU within 24 hours
Key inclusion criteria (6 listed)
- Patients aged > 18 years
- Admitted to a participating ICU within 24 hours
- Significant organ dysfunction involving at least two organ systems. This is defined as fulfilling both of the following:
- Given informed consent from patient or permission to participate from next of kin
Key exclusion criteria (3 listed)
- Echocardiographic examination not possible (e.g., pneumothorax, draping etc) or very low echocardiographic examination quality
- Not being examined with echocardiography within 24 hours from inclusion
- Retracted consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyAll patients in the study will be examined with echocardiography | Diagnostic test | Left ventricular dysfunction, Normal left ventricular systolic function |
| Cardiac magnetic resonance imagingAlso: cMRISub-group of patients with left ventricular systolic dysfunction will be examined with cMRI | Diagnostic test | Left ventricular dysfunction |
| Coronary CTAlso: CCTSub-group of patients with left ventricular systolic dysfunction will be examined with CCT | Diagnostic test | Left ventricular dysfunction |
Primary outcome
90-days mortality
Time frame: 90 days
Death
3 secondary outcomes
Alive outside ICU
Time frame: 90 days
Alive without mechanical ventilation
Time frame: 90 days
Alive without CRRT
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multi Organ Failure and Left Ventricular Dysfunction, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonatan Oras, MD, PhD (+46313421000, jonatan.oras@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-days mortality (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.