Surgical Management of Valvular Endocarditis

January 26, 2021 updated by: Ahmed Mohammed Ahmed Mohammed Hassan Makhlof, Assiut University

Surgical Management of Valvular Infective Endocarditis = a Single Centre Experience

This study aims to achieve the following objectives

  • objective 1 : To review the Investigators' experience of surgical management of infective endocarditis (IE) and analyze the outcomes and associated prognostic factors
  • objective 2 : To provides information on early and late clinical outcomes of patients undergoing surgery for IE
  • objective 3 : To evaluate the impact of perioperative clinical variables and identification of perioperative prognostic factors
  • objective 4 : To determine the indications of surgical intervention and the best time of the surgery

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The role of surgery in active infective endocarditis (IE) has been expanding since the first report of successful ventricular septal repair and removal of tricuspid vegetation in 1961 and the first successful valve replacement during active IE in 1965 "4".

The risk of death and complications of infective endocarditis (IE) treated medically has to be balanced against those from surgery in constructing a therapeutic approach .

The results of surgery depend upon many factors. The general preoperative condition of the patient, antibiotic treatment, timing of surgery, perioperative management, surgical techniques( including choice of methods for reconstruction), postoperative management, and follow-up are all important determinants of outcome .

Despite substantial improvements made in the diagnosis and management of infective endocarditis (IE), infective endocarditis remains a serious condition that is associated with significant morbidity and mortality. Compared with antibiotic treatment alone, surgery for IE has greatly increased survival "1".

Surgery for IE is required in 25-30% of cases during the acute phase and in 20-40% during the convalescent phase "2". The most common indications for surgery in IE include intractable heart failure, uncontrolled infection related to peri-valvular extension and resistant organisms, recurrent embolic events and presence of prosthetic material "3".

Risk stratification to identify patients at high risk of developing significant morbidity and mortality is important in the management of IE. Some authors have found operation during the acute phase of endocarditis to be associated with a higher risk of persistent or early recurrent prosthetic valve endocarditis (PVE)"5". Other studies did not find an increased recurrence rate "6", particularly not after surgery for mitral valve endocarditis "7". In general, the prognosis is better after early surgery undertaken before the cardiac pathology and the general condition of the patient have deteriorated too severely "8"

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

All patients who meet the inclusion criteria will be managed in Asyut university hospitals . The information gathered from the eligible patients will be entered into a data sheet containing the variables of interest that will be analysed later at the end of the study. This study will not alter the patients' treatment and follow up at our centre, by any means. In-hospital mortality was defined as all-cause mortality during the hospital stay for the surgical treatment of IE.Variable of interest includes : age , gender , left ventricular ejection fraction , Diabetes mellitus , Renal failure (creatinine clearance<60 ml/min), Atrial fibrillation, Previous cardiac surgery , Coronary artery disease and Preoperative stroke

Description

Inclusion Criteria:

  • patients with native or prosthetic valve infective endocarditis treated with open heart surgery
  • patients without severe neurological injury and CT evidence of hemorrhagic transformation .
  • patients equal to or older than eighteen years old

Exclusion Criteria:

  • Cases of infective endocarditis related to non-valvular cardiovascular devices, such as pacemakers and catheters .
  • cases of infective endocarditis managed non-surgically
  • patients with severe neurological evidence and CT evidence of hemorrhagic transformation .
  • patients younger than eighteen years old
  • patients who refuse to enroll in this study

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
Rate of mortality post-operative
Time Frame: up to one year post-operative
The primary endpoint in this study will be overall cumulative postoperative survival up to one year post-operatively , which will me meassured by the mortalitiy rates . All-cause mortality such as development of sepsis , complications related to stroke , and the development of multisystem organ failure will be discussed . All mortality factors including age of the patient , size of vegetations , type of the involved valve wheather native or prosthetic , Cardiopulmonary bypass time will be well analysed . Statistical analyses were performed using (SPSS) program version 20 (IBM Corporation; Endicott, New York, USA).
up to one year post-operative
The incidince of recurrent endocarditis
Time Frame: up to one year post-operative
The incidince of recurrence of the disease will be on of the primary outcomes in this study . It will be measured by follow up echocardiography , physical signs of the patient , and blood cultures . The following variables will be analyzed for each case: site of infection, active infection at surgery, drug abuse, presence of type 2 diabetes, perivalvular involvement, prosthetic endocarditis, positive blood cultures, previous embolism, and type of prosthetic valve implanted .
up to one year post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expected early and late complications post-operative
Time Frame: up to one year post-operative

Early and late complications post-surgical management

  • Expected early complications include : multi-organ failure secondary to low cardiac output syndrome, fulminant sepsis secondary to residual IE or hospital-acquired pneumonia , acute intracranial hemorrhage, Reoperation for bleeding , Reoperation (valve-related) and Permanent pacemaker .
  • Expected late complications include : reoperation for recurrent or residual IE, for structural valve deterioration of a biological prosthesis , for nonstructural dysfunction and for valve thrombosis of a mechanical valve prosthesis .
up to one year post-operative

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Ali Mohammed Abd-Elwahab, professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ANTICIPATED)

March 1, 2021

Primary Completion (ANTICIPATED)

March 1, 2022

Study Completion (ANTICIPATED)

November 1, 2022

Study Registration Dates

First Submitted

September 23, 2020

First Submitted That Met QC Criteria

September 26, 2020

First Posted (ACTUAL)

October 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Valvular endocarditis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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