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Left Ventricular Dysfunction in Critically Ill Patients (LEVEDYCIP)

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ClinicalTrials.gov Identifier: NCT03787810
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Jonatan Oras, Sahlgrenska University Hospital, Sweden

Brief Summary:
Left ventricular dysfunction is common in the critically ill. The aim of this study is to assess the incidence and prognosis of left ventricular dysfunction in critically ill patients.

Condition or disease Intervention/treatment
Left Ventricular Dysfunction Critically Ill Acute Coronary Syndrome Cardiomyopathies Takotsubo Cardiomyopathy Diagnostic Test: Echocardiography

Detailed Description:
Left ventricular dysfunction is common in the critically ill. A number of conditions can cause left ventricular dysfunction including myocardial infarction, septic cardiomyopathy, post resuscitation syndrome, takotsubo syndrome etc. A number of studies have assessed cardiac dysfunction in specific conditions (e.g. sepsis, cardiac arrest) but only a few studies have assessed cardiac dysfunction in a general ICU-population. The study will focus on diagnostics of the different types of cardiomyopathy and differentiating between ischemic and non-ischemic left ventricular dysfunction in a general ICU population. The aim of this study is to assess the incidence and prognosis of the different types of left ventricular dysfunction in critically ill patients. Our hypothesis is that left ventricular dysfunction is common in the critically ill and is associated with an increased risk of short-term death.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Left Ventricular Dysfunction in Critically Ill Patients
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : February 20, 2019
Estimated Study Completion Date : August 20, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Echocardiography
    Echocardiography for assessment of left ventricular dysfunction


Primary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]
    All cause mortality after admission to the ICU


Biospecimen Retention:   Samples Without DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
General ICU population
Criteria

Inclusion Criteria:

  • Admitted within 24 hours to the ICU
  • Dysfunction of at least one organ system, defined as at least +1 point in SOFA-score.

Exclusion Criteria

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787810


Contacts
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Contact: Jonatan Oras, MD, PhD +46736370350 jonatan.oras@vgregion.se
Contact: Oscar Cavefors, MD +46313428057 oscar.cavefors@vgregion.se

Locations
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Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Västra Götalandsregionen, Sweden, 41345
Contact: Jonatan Oras, MD, PhD    +46736370350    jonatan.oras@vgregion.se   
Contact: Oscar Cavefors, MD    +46313428057    oscar.cavefors@vgregion.se   
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
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Principal Investigator: Jonatan Oras, MD, PhD Sahlgrenska Academy, University of Gothenburg

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Responsible Party: Jonatan Oras, Consultant, adjunct senior lecturer, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT03787810     History of Changes
Other Study ID Numbers: LEVEDYCIP
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Not decided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Acute Coronary Syndrome
Cardiomyopathies
Critical Illness
Ventricular Dysfunction
Ventricular Dysfunction, Left
Takotsubo Cardiomyopathy
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Disease Attributes
Pathologic Processes