ClinicalTrials.Veeva

Menu

Impact of Early Cardiac Surgery in Severe Left Endocarditis With Neurological Complications: a Retrospective Study (ICE-COCA)

G

Gros, Alexandre, M.D.

Status

Completed

Conditions

Endocarditis
Neurologic Complication

Treatments

Procedure: Cardiac surgery

Study type

Observational

Identifiers

NCT04387513
AlexandreGros

Details and patient eligibility

About

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.

Full 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.

Enrollment

192 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems