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

NCT04387513 | Completed

• 1 other identifier: AlexandreGros
• Study Type: observational
• Target: 192
• Locations: 0 countries
• Sites: N/A

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. 1.Analyze the factors associated with neurological degradation
2. 2.Evaluate the neurological tolerance of cardiac surgery.

Conditions

Endocarditis; Neurologic Complication

Outcome Measures

Primary Outcomes (1)

• Mortality

  Death from any cause

  at 1 year after the diagnosis of endocarditis

Secondary Outcomes (1)

• Neurogical tolerance

  At 6 months

Interventions

Cardiac surgery PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients in intensive care unit. They all have an indication of surgery, but they are not all operated (neurological or others contre-indications).

You may qualify if:

• Left endocarditis
• With indication of cardiac surgery
• Severe endocaditis (SOFA score \> or = 3/16)
• With pre operative neurological complications

You may not qualify if:

• Age \< 18
• Right endocarditis without left endocarditis
• No severe endocarditis (SOFA score \< 3)
• Ne pre operative neurological complications
• Endocarditis without indication of cardiac surgery

Sponsors & Collaborators

• Gros, Alexandre, M.D.: lead

MeSH Terms

Conditions

Endocarditis

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: GROS, Alexandre, Medical Doctor, Intensive Care Unit, Principal Investigator

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 14, 2020
• Study Start: August 1, 2010
• Primary Completion: August 18, 2010
• Study Completion: December 31, 2017
• Last Updated: May 19, 2020

Record last verified: 2020-05