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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03787810
Other study ID # LEVEDYCIP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 28, 2018
Est. completion date February 20, 2020

Study information

Verified date September 2019
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 428
Est. completion date February 20, 2020
Est. primary completion date February 20, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

-

Study Design


Intervention

Diagnostic Test:
Echocardiography
Echocardiography for assessment of left ventricular dysfunction

Locations

Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg Västra Götalandsregionen

Sponsors (1)

Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality All cause mortality after admission to the ICU 30 days
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