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

May 17, 2020 updated by: Dr Alexandre Gros, Gros, Alexandre, M.D.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

192

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: at 1 year after the diagnosis of endocarditis
Death from any cause
at 1 year after the diagnosis of endocarditis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurogical tolerance
Time Frame: At 6 months
Modified Rankin score after cardiac surgery, 0 (no symptoms at all) to 6 (death)
At 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gros, Alexandre, M.D.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2010

Primary Completion (Actual)

August 18, 2010

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

May 10, 2020

First Submitted That Met QC Criteria

May 10, 2020

First Posted (Actual)

May 14, 2020

Study Record Updates

Last Update Posted (Actual)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 17, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AlexandreGros

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

All individual data are available in an Excel file.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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