Characteristics of Infective Endocarditis in East China

July 26, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study of the Clinical Presentations, Treatment and Outcomes of Infective Endocarditis Patients in a Tertiary Hospital in East China

This was a retrospective observational study of consecutive cases of definite or possible infective endocarditis (IE) as per the modified Duke criteria between January 2008 and December 2015, which was performed at the Second Affiliated Hospital of Zhejiang University, School of medicine (SAHZU), a tertiary care referral hospital located in East China.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Infective endocarditis (IE) is a rare but life-threatening serious disease that still has a high mortality, even in developed countries. The objective of this study was to evaluate the clinical presentations, treatment and outcomes of IE patients in a tertiary hospital in East China over an 8-year period. This was a retrospective observational study of consecutive cases of definite or possible IE as per the modified Duke criteria between January 2008 and December 2015.

Study Type

Observational

Enrollment (Actual)

183

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a clinical diagnosis of infective endocarditis between January 2008 and December 2015 in a tertiary hospital located in the East China

Description

Inclusion Criteria:

  • Patients with a clinical diagnosis of infective endocarditis.

Exclusion Criteria:

  • Patients did not meet the modified Duke criteria.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients diagnosed during 2008-2011
Patients diagnosed with definite and probable infective endocarditis defined according to the modified Duke clinical criteria during 2008-2011
Other: no intervention
no intervention
Patients diagnosed during 2012-2015
Patients diagnosed with definite and probable infective endocarditis defined according to the modified Duke clinical criteria during 2012-2015
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications (neurological events, systemic embolism, and congestive heart failure) of infective endocarditis
Time Frame: During the hospitalization, average of 1 months
  1. A neurological event was defined as symptomatic or asymptomatic stroke, hemorrhage, or encephalopathy.
  2. Systemic embolization was defined as an embolic event outside of the central nervous system.
  3. Congestive heart failure was defined as with class III, or IV heart failure and an ejection fraction of 40% or less.
During the hospitalization, average of 1 months
Mortality
Time Frame: During the hospitalization, average of 1 months
Patients dead or moribund before discharge
During the hospitalization, average of 1 months

Collaborators and Investigators

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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: Huimin Xu, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

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 (Actual)

January 1, 2008

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

October 20, 2016

Study Registration Dates

First Submitted

July 13, 2021

First Submitted That Met QC Criteria

July 26, 2021

First Posted (Actual)

July 27, 2021

Study Record Updates

Last Update Posted (Actual)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data shared by published papers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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