Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06150092
Status:
RECRUITING
Last Update Posted:
2023-11-29
First Post:
2023-11-16
Brief Title:
Use of Presepsin in the Emergency Department
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Use of Presepsin for Early Diagnosis of Sepsis in the Emergency Room
Status:
RECRUITING
Status Verified Date:
2023-11
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:
P-SEP
Brief Summary:
Sepsis is an extremely common systemic condition in the Emergency Room ER which is found to be to be one of the leading causes of death among patients accessing the ER
To date the diagnosis of sepsis does not rely on any specific markers for infectious conditions but several methods of assessing the general condition of the patient namely markers that elevate in a variety of inflammatory conditions PCR PCT indices of tissue hypoxia serum lactate and scores based on the haemochromocytometric examination the markers of function of different organs and vital parameters expressed by the patient at the time of assessment SOFA qSOFA SIRS NEWS These markers in addition to not be specific for sepsis have an insufficiently early peak of presentation to readily identify all patients presenting with this condition
Presepsin as the N-terminal portion of the soluble component of Cluster of Differentiation 14 CD14 is elevated almost exclusively in infectious conditions moreover its elevation in infectious contexts is extremely early compared with that of markers already in use allowing early identification of septic patients who to date would be recognized as such only hours after the onset of the septic process In addition the determination of this biomarker could make it possible to stratify patients by prognosis allowing greater attention to be paid to the most severe patients
It is hypothesized that the Presepsin assay in emergency room will allow to increase the rapidity and specificity of sepsis diagnosis compared with the diagnostic procedure currently used improving the outcomes of patients accessing the emergency room with symptoms suggestive of sepsis
The main purpose of the present study is to evaluate the role of serum assay of presepsin in the early diagnosis of sepsis in patients presenting to the emergency department with clinical suspicion of sepsis by comparing the values obtained with traditionally used such as PCR PCT and blood culture The secondary objective is to evaluate presepsin as a prognostic biomarker and useful for mortality risk stratification of the same patients comparing the values obtained with validated predictor scores of mortality andor severity APACHEII SOFA qSOFA
To date the diagnosis of sepsis does not rely on any specific markers for infectious conditions but several methods of assessing the general condition of the patient namely markers that elevate in a variety of inflammatory conditions PCR PCT indices of tissue hypoxia serum lactate and scores based on the haemochromocytometric examination the markers of function of different organs and vital parameters expressed by the patient at the time of assessment SOFA qSOFA SIRS NEWS These markers in addition to not be specific for sepsis have an insufficiently early peak of presentation to readily identify all patients presenting with this condition
Presepsin as the N-terminal portion of the soluble component of Cluster of Differentiation 14 CD14 is elevated almost exclusively in infectious conditions moreover its elevation in infectious contexts is extremely early compared with that of markers already in use allowing early identification of septic patients who to date would be recognized as such only hours after the onset of the septic process In addition the determination of this biomarker could make it possible to stratify patients by prognosis allowing greater attention to be paid to the most severe patients
It is hypothesized that the Presepsin assay in emergency room will allow to increase the rapidity and specificity of sepsis diagnosis compared with the diagnostic procedure currently used improving the outcomes of patients accessing the emergency room with symptoms suggestive of sepsis
The main purpose of the present study is to evaluate the role of serum assay of presepsin in the early diagnosis of sepsis in patients presenting to the emergency department with clinical suspicion of sepsis by comparing the values obtained with traditionally used such as PCR PCT and blood culture The secondary objective is to evaluate presepsin as a prognostic biomarker and useful for mortality risk stratification of the same patients comparing the values obtained with validated predictor scores of mortality andor severity APACHEII SOFA qSOFA
Detailed Description:
Study design Prospective observational study without drug or device
Sample definition 300 consecutive patients will be included in the study who enter the emergency department with symptoms suggestive of sepsis and who meet the criteria for eligibility The blood sampling required for the presepsin assay will take place concurrently with the blood draws required for routine testing Assuming that approximately 70 percent of patients will have a confirmed diagnosis of sepsis and assuming an Area Under the Roc Curve AUC of 080 this number of patients will allow the AUC of presepsin dosing to be estimated with a 95 confidence interval of overall magnitude of 010 thus obtaining an estimate interval from 075 to 085
Duration of the study The duration of the study will be 18 months from the approval of the this protocol by the Territorial Ethics Committee TEC The enrollment phase of the patients will last 12 months while the next 6 months will be devoted to data extraction statistical analysis and scientific reporting
Procedures Prospectively enrolled patients will be selected by the attending physician at the time of the first visit and if eligible will be asked for written informed consent to participation in the study Patients will be enrolled during emergency evaluation as part of standard care in the EM and during blood draws as required by clinical practice routine practice a venous blood sample will be taken at the time of the visit It will be performed serum analysis and presepsin assay obtained without additional blood draws
Variables of interest
Presepsin a peripheral blood sample will be collected by blood sampling and its blood concentration will be assayed in the highly automated CoreLab of the Polyclinic A Gemelli in Rome
Serum lactate if part of the patients diagnostic therapeutic pathway it will be dosed directly in the ER through the device Hemogasanalyzer pO2 ABL90 FLEX present in the ER
History will be collected by the ER physician who visits the patient
Scores will be calculated based on clinical data obtained during the stay in the ER
Serum creatinine PCR PCT CBC examination blood culture and urinocultures Collection of biological material will be carried out in the emergency room of the A Gemelli University Polyclinic in Rome IRCCS laboratory evaluation and storage of biological material for molecular analysis for the current study will be carried out at the highly automated CoreLab of University Polyclinic A Gemelli of Rome IRCCS
Length of visit to the ER
Complications during the stay in the ER and possible admission to intensive care unit or death from any cause
Amendments to the protocol Any amendments to the protocol will be promptly communicated to the Ethics Committee by the investigators This will configure the request for additional informed consent which will be submitted to all patients included in the study
Error
Incorrect association between blood sample and patient
insufficient sample for laboratory evaluation
errors in the laboratory report
errors in data storage
These possible errors will be minimized by the establishment of specific procedures
related to the study
Confounding factors Presepsin values increase
In cases of renal failure but recent studies allow its value to be framed in light of renal function
In pediatric age but our study includes only adult patients
In noninfected burn cases which are not included in the study and which will be identified through a thorough history and objective examination
Sample definition 300 consecutive patients will be included in the study who enter the emergency department with symptoms suggestive of sepsis and who meet the criteria for eligibility The blood sampling required for the presepsin assay will take place concurrently with the blood draws required for routine testing Assuming that approximately 70 percent of patients will have a confirmed diagnosis of sepsis and assuming an Area Under the Roc Curve AUC of 080 this number of patients will allow the AUC of presepsin dosing to be estimated with a 95 confidence interval of overall magnitude of 010 thus obtaining an estimate interval from 075 to 085
Duration of the study The duration of the study will be 18 months from the approval of the this protocol by the Territorial Ethics Committee TEC The enrollment phase of the patients will last 12 months while the next 6 months will be devoted to data extraction statistical analysis and scientific reporting
Procedures Prospectively enrolled patients will be selected by the attending physician at the time of the first visit and if eligible will be asked for written informed consent to participation in the study Patients will be enrolled during emergency evaluation as part of standard care in the EM and during blood draws as required by clinical practice routine practice a venous blood sample will be taken at the time of the visit It will be performed serum analysis and presepsin assay obtained without additional blood draws
Variables of interest
Presepsin a peripheral blood sample will be collected by blood sampling and its blood concentration will be assayed in the highly automated CoreLab of the Polyclinic A Gemelli in Rome
Serum lactate if part of the patients diagnostic therapeutic pathway it will be dosed directly in the ER through the device Hemogasanalyzer pO2 ABL90 FLEX present in the ER
History will be collected by the ER physician who visits the patient
Scores will be calculated based on clinical data obtained during the stay in the ER
Serum creatinine PCR PCT CBC examination blood culture and urinocultures Collection of biological material will be carried out in the emergency room of the A Gemelli University Polyclinic in Rome IRCCS laboratory evaluation and storage of biological material for molecular analysis for the current study will be carried out at the highly automated CoreLab of University Polyclinic A Gemelli of Rome IRCCS
Length of visit to the ER
Complications during the stay in the ER and possible admission to intensive care unit or death from any cause
Amendments to the protocol Any amendments to the protocol will be promptly communicated to the Ethics Committee by the investigators This will configure the request for additional informed consent which will be submitted to all patients included in the study
Error
Incorrect association between blood sample and patient
insufficient sample for laboratory evaluation
errors in the laboratory report
errors in data storage
These possible errors will be minimized by the establishment of specific procedures
related to the study
Confounding factors Presepsin values increase
In cases of renal failure but recent studies allow its value to be framed in light of renal function
In pediatric age but our study includes only adult patients
In noninfected burn cases which are not included in the study and which will be identified through a thorough history and objective examination
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