An observational study in Valvular Endocarditis, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-27.
Sponsored by Assiut University · Observational
This study aims to achieve the following objectives
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"
170 studies on the registry are indexed under Endocarditis; 51 are open to participants now.
This study's planned enrollment of 50 is below the median of 263 across 81 observational studies indexed under Endocarditis.
Browse Endocarditis studies →Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.
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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
Exclusion Criteria:
Open heart surgery to replace the valvular infective endocarditis
Rate of mortality 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).
Time frame: up to one year post-operative
The incidince of recurrent endocarditis
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 .
Time frame: up to one year post-operative
Expected early and late complications 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 .
Time frame: up to one year post-operative
No study locations are listed for this record.
Plan to share: Undecided
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Assiut University