The ENDOCARDITIS AUMC Data Collection

Recruiting

• Conditions: Endocarditis; Coagulation Disorder; Valve Disease, Heart
• Interventions: Other: None, observational

• Registration Number: NCT05139589
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

The investigators will compare patients with and without infective ndocarditis undergoing valve surgery and evaluate factors that may help optimise perioperative care of these high-risk patients.

Detailed Description

The aim of this study is to examine the differences between patients with and without endocarditis who undergo cardiothoracic (valve) surgery. In addition, the investigators will look at the differences between endocarditis patients who undergo surgery, and those who are treated conservatively. The investigators will look at incidence and degree of perioperative coagulation abnormalities, as well as transfusion and coagulation factor requirements, heparin resistance, bleeding scores, predictive endocarditis mortality scores, vasopressor-inotrope scores, and relate these where possible to the pathogen causing IE. The investigators will also look at perioperative complications, in particular, thromboembolic events and mortality at 30 and 90 days, and at 1 year.

These outcomes may help optimise perioperative care for high-risk endocarditis patients, and in particular those undergoing valve surgery.

Study Timeline

• Study First Submitted: 2021-11-30
• Study First Submitted QC: 2021-11-30
• Study First Posted: 2021-12-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-25
• Study Start: 2023-08-06
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Patients > 18 years
• Dutch or English speaking
• All patients with infective endocarditis admitted to Amsterdam UMC in the study period
• All patients with infective endocarditis scheduled for cardiac valve surgery compared to a matched cohort of patients scheduled for similar surgery due to non-infectious indication in Amsterdam UMC in the same period

Exclusion Criteria

• Previous history of coagulation disorders

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infective endocarditis, surgical arm	None, observational	Patients with infective endocardits requiring valve surgery
Infective endocarditis, conservative arm	None, observational	Patients with infective endocardits, not requiring valve surgery
Valve disease, heart, surgically repaired	None, observational	Patients requiring valve surgery

Primary Outcome Measures

Name	Time	Method
Thromboembolic complications	up to 1 year	Any thromboembolic complications occuring between surgery and 1 year post operatively (incidence, class and severity)

Secondary Outcome Measures

Name	Time	Method
Incidence of perioperative coagulation abnormalities	First 24 hours after surgery	How often perioperative coagulation abnormalities, measured by classical laboratory values and rotational thromboelastometry are seen from diagnosis to 24 hours post-surgery
Differences in incidence of pathogens and the relation with disease severity	Up to 30 days	To evaluate the effect of different pathogens (evaluated by laboratory results) on the clinical status

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam, North Holland, Netherlands