Early Clinical, Laboratory and Microbiological Predictors of Treatment Outcomes in Infective Endocaridtis

Infective Endocarditis Clinical Trial

— CRP-IE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02466139
• Other study ID #: IEregister2012-2015
• Status: Completed
• Phase: N/A
• First received: June 2, 2015
• Last updated: June 4, 2015
• Start date: April 2012
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• Source: Government Medical College, Kozhikode
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Fulfillment of modified Duke criteria

Exclusion Criteria:

• No consent

• inadequate baseline data

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Government Medical College, Kozhikode

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital mortality		30 days	No
Primary	Major complications		30 days	No
Secondary	Number of patients who had embolic events		30 days	No
Secondary	Number of patients who needed urgent cardiac surgery		30 days	No
Secondary	Short term Mortality		6 months	No