Left Ventricular Dysfunction in Critically Ill Patients (LEVEDYCIP)

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.

Study Overview

• Status: Completed
• Conditions: Cardiomyopathies; Acute Coronary Syndrome; Critically Ill; Takotsubo Cardiomyopathy; Left Ventricular Dysfunction
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 428

Contacts and Locations

Study Locations

• Sweden
  • Västra Götalandsregionen
    • Gothenburg, Västra Götalandsregionen, Sweden, 41345
      • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

General ICU population

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	All cause mortality after admission to the ICU	30 days

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Investigators: Principal Investigator: Jonatan Oras, MD, PhD, Sahlgrenska academy, University of Gothenburg

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2018
• Primary Completion (Actual): February 20, 2019
• Study Completion (Actual): February 20, 2020

Study Registration Dates

• First Submitted: December 23, 2018
• First Submitted That Met QC Criteria: December 23, 2018
• First Posted (Actual): December 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 21, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Critical Illness; Cardiomyopathies; Acute Coronary Syndrome; Ventricular Dysfunction; Takotsubo Cardiomyopathy; Ventricular Dysfunction, Left
• Other Study ID Numbers: LEVEDYCIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No