Impact of Early Cardiac Surgery in Severe Left Endocarditis With Neurological Complications: a Retrospective Study

Endocarditis Clinical Trial

— ICE-COCA  

Official title:

Impact of Cardiac Surgery in Severe Left Endocarditis With Neurological Complications: a Multicentric,Retrospective, Propensity-score Matching Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04387513
• Other study ID #: AlexandreGros
• Status: Completed
• Start date: August 1, 2010
• Est. completion date: December 31, 2017

Study information

• Verified date: May 2020
• Source: Gros, Alexandre, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Surgical delay in severe endocardits, with neurological complications, is still debated. Early surgery, if indicated, permits to avoid new embolic events, or to fix valvular damages, but can create or increase a cerebral hemorrage.

Hypothesis Cardiac surgery, as soon as possible, if indicated, would reduce mortality, in severe left endocarditis, with neurological complications.

Primary objective To assess the impact of early versus late cardiac surgery on mortality at 1 year, in patients with severe endocarditis, with neurological complications.

Primary endpoint:

1) Mortality at 1 year

Secondary endpoints:

1. Analyze the factors associated with neurological degradation

2. Evaluate the neurological tolerance of cardiac surgery.

Description:

Surgical delay in severe endocardits, with neurological complications, is still debated. Early surgery, if indicated, permits to avoid new embolic events, or to fix valvular damages, but can create or increase a cerebral hemorrage.

Hypothesis Cardiac surgery, as soon as possible, if indicated, would reduce mortality, in severe left endocarditis, with neurological complications.

Primary objective To assess the impact of early versus late cardiac surgery on mortality at 1 year, in patients with severe endocarditis, with neurological complications.

Primary endpoint:

1) Mortality at 1 year

Secondary endpoints:

1. Analyze the factors associated with neurological degradation

2. Evaluate the neurological tolerance of cardiac surgery.

Methods Multicentric study (7 French university hospitals). Retrospective study: from august 2010 to december 2017. Propensity score matching study. 192 patients are included.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: December 31, 2017
• Est. primary completion date: August 18, 2010
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Left endocarditis

• With indication of cardiac surgery

• Severe endocaditis (SOFA score > or = 3/16)

• With pre operative neurological complications

Exclusion Criteria:

• Age < 18

• Right endocarditis without left endocarditis

• No severe endocarditis (SOFA score < 3)

• Ne pre operative neurological complications

• Endocarditis without indication of cardiac surgery

Related Conditions & MeSH terms

• Endocarditis
• Neurologic Complication

Intervention

Procedure:
• Cardiac surgery
Cardiac surgery, if indicated, delayed or not by neurological complications

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gros, Alexandre, M.D.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Death from any cause	at 1 year after the diagnosis of endocarditis
Secondary	Neurogical tolerance	Modified Rankin score after cardiac surgery, 0 (no symptoms at all) to 6 (death)	At 6 months