CClinicalTrials.gg
CompletedNCT04387513ICE-COCAUpdated May 19, 2020

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

An observational study in Endocarditis and Neurologic Complication, sponsored by Gros, Alexandre, M.D.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-19.

Sponsored by Gros, Alexandre, M.D. · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
192
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Endocarditis
  • Neurologic Complication

Browse trials for

03

In context

Endocarditis

170 studies on the registry are indexed under Endocarditis; 51 are open to participants now.

This study's enrollment of 192 is below the median of 263 across 81 observational studies indexed under Endocarditis.

Browse Endocarditis studies →

Lead sponsor

This is the only study on the registry with Gros, Alexandre, M.D. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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).

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
192 participants (actual)
Patient registry
No

Interventions

  • ProcedureCardiac surgery

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

06

What researchers measure

Primary outcomes

  1. Mortality

    Death from any cause

    Time frame: at 1 year after the diagnosis of endocarditis

Secondary outcomes

  1. Neurogical tolerance

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

    Time frame: At 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — All individual data are available in an Excel file.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04387513
Lead sponsor
Gros, Alexandre, M.D.
Responsible party
Dr Alexandre Gros (GROS, Alexandre, Medical Doctor, Intensive Care Unit, Principal Investigator, Gros, Alexandre, M.D.) — Principal investigator
First posted
May 14, 2020
Start date
Aug 1, 2010
Primary completion
Aug 18, 2010
Completion
Dec 31, 2017
Last update
May 19, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion