Retrospective Safety Study to Compare Mortality in Intensive Care Unite (ICU) Patients Undergoing Echocardiography With or Without DEFINITY® (DEF-418)

November 6, 2020 updated by: Lantheus Medical Imaging

A Retrospective Observational Database Study To Compare In-Hospital All-Cause Mortality in Critically Ill Patients Undergoing Echocardiography With or Without DEFINITY®

Retrospective analysis to observe changes in short term mortality

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

4300000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • N. Billerica, Massachusetts, United States, 01862
        • Lantheus Medical Imaging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All that received an echocardiogram

Description

Inclusion Criteria:

  • Males and females
  • At least 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Non-contrast echocardiography
Contrast Echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Short term mortality
Time Frame: 48 hours post echo produre
48 hours post echo produre

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lantheus Medical Imaging

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

February 16, 2011

First Submitted That Met QC Criteria

February 17, 2011

First Posted (Estimate)

February 18, 2011

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMP 115-418

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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