Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05791357
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2023-02-27
Brief Title:
The Role of Polymerase Chain Reaction in the Management of Patients With Infective Endocarditis
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
The Role of Polymerase Chain Reaction in the Management of Patients With Infective Endocarditis Modern Diagnostic and Therapeutic Concepts
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to prospectively investigate the additional diagnostic value of broad range PCR targeting the 16 ribosomal DNA in diagnosis and management of patients with infective endocarditis who are candidate for surgicaltherapy
Detailed Description:
Study protocol is divided into four different phasesscreening pre-operative clinical assessment T-1 cardiac surgery T0 and follow-up period T4 eT90
During the screening phase patients will be assessed to determine whether they met the study inclusionexclusion criteria After signing the informed consent patients will go through a preoperative clinical evaluation T-1 The following assessments are carried out the day before surgery recording patients generality present antibiotic therapy and possible results of blood cultures performed prior to recruitment - Twelve-lead ECG - chest X-ray - transthoracic echocardiogram TTE - three pairs of blood cultures from three different blood sampling sites In cases of complicated endocarditis the presence and location of septic embolisms is recorded using Total body CT scan imaging signs of heart failure evaluated and operability criteria are assessed On the day of cardiac surgery T0 main intraoperative data valve findings type of prosthesis surgery time cardiopulmonary bypass time and aortic cross clamping time will be gathered the excised valve was sent partly to the microbiology laboratory for culture and molecular tests and partly to the pathology Laboratory
After cardiac surgery patients continued to be monitored for a follow up at four T4 and 90 T90 days after surgery During the follow-up period information was collected on the patients clinical status vital parameters and the antibiotic treatment performed The same blood tests performed at T-1 are repeated at T4 and T90 All this data was recorded on a dedicated database
During the screening phase patients will be assessed to determine whether they met the study inclusionexclusion criteria After signing the informed consent patients will go through a preoperative clinical evaluation T-1 The following assessments are carried out the day before surgery recording patients generality present antibiotic therapy and possible results of blood cultures performed prior to recruitment - Twelve-lead ECG - chest X-ray - transthoracic echocardiogram TTE - three pairs of blood cultures from three different blood sampling sites In cases of complicated endocarditis the presence and location of septic embolisms is recorded using Total body CT scan imaging signs of heart failure evaluated and operability criteria are assessed On the day of cardiac surgery T0 main intraoperative data valve findings type of prosthesis surgery time cardiopulmonary bypass time and aortic cross clamping time will be gathered the excised valve was sent partly to the microbiology laboratory for culture and molecular tests and partly to the pathology Laboratory
After cardiac surgery patients continued to be monitored for a follow up at four T4 and 90 T90 days after surgery During the follow-up period information was collected on the patients clinical status vital parameters and the antibiotic treatment performed The same blood tests performed at T-1 are repeated at T4 and T90 All this data was recorded on a dedicated database
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None