Valvular EndocarditisNCT04572529
Surgical Management of Valvular Endocarditis
An observational study of Valvular Endocarditis, run by Assiut University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valvular Endocarditis
- What is being tested?
- Cardiac Valve replacement
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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"
- Conditions
- Valvular Endocarditis
- Being tested
- Cardiac Valve replacement
- Keywords
- Endocarditis, Vegetations, Heart valve prosthesis implantation
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Valve replacementProcedure or surgery
Open heart surgery to replace the valvular infective endocarditis
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 .
Measured: up to one year post-operative
Secondary outcomes (1)
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 .
Measured: up to one year post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Mar 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Valvular EndocarditisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Ahmed Mohammed Hassan Makhlof, Assiut University
- Investigators
- Ali Mohammed Abd-Elwahab, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572529
- Sponsor's protocol ID
- Valvular endocarditis
- Status last verified
- Jan 2021
- First submitted
- 23 Sep 2020
- Last updated
- 27 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 12067947Olaison 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.
PubMed 12092482Daniel 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.
PubMed 1997851KAY 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.
PubMed 13752022Chastre 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.
PubMed 7671922Verheul 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.
PubMed 8249845Wolff 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.
PubMed 7656617Jault 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.
PubMed 9205176
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Management of Valvular Infective Endocarditis = a Single Centre Experience
- ClinicalTrials.gov ID
- NCT04572529
- Acronym / sponsor ID
- Valvular endocarditis
- Conditions
- Valvular Endocarditis
- Keywords
- Endocarditis, Vegetations, Heart valve prosthesis implantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Valve replacementOpen heart surgery to replace the valvular infective endocarditis | Procedure or surgery | – |
Primary outcome
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).
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 .
1 secondary outcome
Expected early and late complications post-operative
Time frame: up to one year post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Background: PubMed 12067947Netzer 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.
- Background: PubMed 12092482Olaison 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.
- Background: PubMed 1997851Daniel 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.
- Background: PubMed 13752022KAY 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.
- Background: PubMed 7671922Chastre 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.
- Background: PubMed 8249845Verheul 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.
- Background: PubMed 7656617Wolff 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.
- Background: PubMed 9205176Jault 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Mohammed Abd-Elwahab, professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Valvular Endocarditis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Mohammed Ahmed Mohammed, specialst (+201005035399, ahmedmohammedmakhlof@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of mortality post-operative (time frame: up to one year post-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04572529, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.