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Completed

NCT Number: NCT04387513

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

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.

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Key information

Conditions

Endocarditis Cardiovascular Diseases Heart Diseases Neurologic Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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:

  • Mortality at 1 year

Secondary endpoints:

  • Analyze the factors associated with neurological degradation
  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiac surgery

Procedure

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

Primary outcomes

  1. Mortality

    Time frame: at 1 year after the diagnosis of endocarditis

    Death from any cause

Secondary outcomes

  1. Neurogical tolerance

    Time frame: At 6 months

    Modified Rankin score after cardiac surgery, 0 (no symptoms at all) to 6 (death)

Sponsors and collaborators

Lead sponsor

Gros, Alexandre, M.D.

Indiv

Registry information

Official study title

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

Acronym: ICE-COCA

Important dates

Study start
2010
Primary completion
2010
Study completion
2017
First posted
May 14, 2020
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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