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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04387513
Acronym
ICE-COCA
Enrollment
192
Registered
2020-05-14
Start date
2010-08-01
Completion date
2017-12-31
Last updated
2020-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endocarditis, Neurologic Complication

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.

Interventions

PROCEDURECardiac surgery

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

Sponsors

Gros, Alexandre, M.D.
Lead SponsorINDIV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Mortalityat 1 year after the diagnosis of endocarditisDeath from any cause

Secondary

MeasureTime frameDescription
Neurogical toleranceAt 6 monthsModified Rankin score after cardiac surgery, 0 (no symptoms at all) to 6 (death)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026