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

NCT ID: NCT04387513

Last Updated: 2020-05-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 192 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-01
• Study Completion Date: 2017-12-31

Brief 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.

Detailed 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.

Conditions

Endocarditis; Neurologic Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Cardiac surgery

Cardiac surgery, if indicated, delayed or not by neurological complications

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gros, Alexandre, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Dr Alexandre Gros

GROS, Alexandre, Medical Doctor, Intensive Care Unit, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

AlexandreGros

Identifier Type: -

Identifier Source: org_study_id