Surgical Management of Valvular Endocarditis

NCT ID: NCT04572529

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-11-30

Brief Summary

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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

Detailed Description

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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"

Conditions

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Valvular Endocarditis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Cardiac Valve replacement

Open heart surgery to replace the valvular infective endocarditis

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohammed Ahmed Mohammed Hassan Makhlof

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali Mohammed Abd-Elwahab, professor

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Ahmed Mohammed Ahmed Mohammed, specialst

Role: CONTACT

+201005035399

Yasser Hamdy Hussein, lecturer

Role: CONTACT

+201115231575

References

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Netzer RO, Altwegg SC, Zollinger E, Tauber M, Carrel T, Seiler C. Infective endocarditis: determinants of long term outcome. Heart. 2002 Jul;88(1):61-6. doi: 10.1136/heart.88.1.61.

Reference Type BACKGROUND
PMID: 12067947 (View on PubMed)

Olaison L, Pettersson G. Current best practices and guidelines indications for surgical intervention in infective endocarditis. Infect Dis Clin North Am. 2002 Jun;16(2):453-75, xi. doi: 10.1016/s0891-5520(01)00006-x.

Reference Type BACKGROUND
PMID: 12092482 (View on PubMed)

Daniel WG, Mugge A, Martin RP, Lindert O, Hausmann D, Nonnast-Daniel B, Laas J, Lichtlen PR. Improvement in the diagnosis of abscesses associated with endocarditis by transesophageal echocardiography. N Engl J Med. 1991 Mar 21;324(12):795-800. doi: 10.1056/NEJM199103213241203.

Reference Type BACKGROUND
PMID: 1997851 (View on PubMed)

KAY JH, BERNSTEIN S, FEINSTEIN D, BIDDLE M. Surgical cure of Candida albicans endocarditis with open-heart surgery. N Engl J Med. 1961 May 4;264:907-10. doi: 10.1056/NEJM196105042641804. No abstract available.

Reference Type BACKGROUND
PMID: 13752022 (View on PubMed)

Chastre J, Trouillet JL. Early infective endocarditis on prosthetic valves. Eur Heart J. 1995 Apr;16 Suppl B:32-8. doi: 10.1093/eurheartj/16.suppl_b.32.

Reference Type BACKGROUND
PMID: 7671922 (View on PubMed)

Verheul HA, van den Brink RB, van Vreeland T, Moulijn AC, Duren DR, Dunning AJ. Effects of changes in management of active infective endocarditis on outcome in a 25-year period. Am J Cardiol. 1993 Sep 15;72(9):682-7. doi: 10.1016/0002-9149(93)90885-g.

Reference Type BACKGROUND
PMID: 8249845 (View on PubMed)

Wolff M, Witchitz S, Chastang C, Regnier B, Vachon F. Prosthetic valve endocarditis in the ICU. Prognostic factors of overall survival in a series of 122 cases and consequences for treatment decision. Chest. 1995 Sep;108(3):688-94. doi: 10.1378/chest.108.3.688.

Reference Type BACKGROUND
PMID: 7656617 (View on PubMed)

Jault F, Gandjbakhch I, Rama A, Nectoux M, Bors V, Vaissier E, Nataf P, Pavie A, Cabrol C. Active native valve endocarditis: determinants of operative death and late mortality. Ann Thorac Surg. 1997 Jun;63(6):1737-41. doi: 10.1016/s0003-4975(97)00117-3.

Reference Type BACKGROUND
PMID: 9205176 (View on PubMed)

Other Identifiers

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Valvular endocarditis

Identifier Type: -

Identifier Source: org_study_id

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