Early Clinical, Laboratory and Microbiological Predictors of Treatment Outcomes in Infective Endocaridtis (CRP-IE)

June 4, 2015 updated by: Sandeep Mohanan, Government Medical College, Kozhikode

Early Clinical, Laboratory and Microbiological Predictors of Treatment Outcomes Among Infective Endocaridtis Patients in a Tertiary-care Centre in Kerala

The investigators conduct a prospective observational study on consecutive patients being admitted to a tertiary care-centre with infective endocarditis. The investigators' primary aim is to identify baseline clincal, laboratory and microbiological predictors of in-hospital events, mortality and 6-month mortality.

Study Overview

Status

Completed

Conditions

Detailed Description

Mortality and major complications among infective endocarditis remain high. In addition developing nations are crippled with a high incidence of culture-negative endocarditis and lack of wide availability of transesophageal echocardiography. We intended to identify predictors among admission clinical features, laboratory paramters and culture reports that can help risk stratify patients early in the course of treatment.

Study Type

Observational

Enrollment (Actual)

102

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

Probability Sample

Study Population

Consecutive patients with infective endocarditis treated in a tertiary care centre

Description

Inclusion Criteria:

  • Fulfillment of modified Duke criteria

Exclusion Criteria:

  • No consent
  • inadequate baseline data

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: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In-hospital mortality
Time Frame: 30 days
30 days
Major complications
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients who had embolic events
Time Frame: 30 days
30 days
Number of patients who needed urgent cardiac surgery
Time Frame: 30 days
30 days
Short term Mortality
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Government Medical College, Kozhikode

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

April 1, 2012

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

June 2, 2015

First Submitted That Met QC Criteria

June 4, 2015

First Posted (Estimate)

June 9, 2015

Study Record Updates

Last Update Posted (Estimate)

June 9, 2015

Last Update Submitted That Met QC Criteria

June 4, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEregister2012-2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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