Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402071
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-05-02
Brief Title:
Clinical Value of the Developed Scoring Systems for Predicting Spontaneous Bacterial Peritonitis in Cirrhotic Ascites
Sponsor:
Dalia Nasser Mohamed
Organization:
Sohag University
Study Overview
Official Title:
Clinical Value of the Developed Scoring Systems for Predicting Spontaneous Bacterial Peritonitis in Cirrhotic Ascites
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Liver cirrhosis is the clinical end stage of different entities of chronic liver disease when patients suffer from considerable mortality and morbidity both of which are correlated positively with disease severity Ascites are the most common complication and around 60 of patients with compensated cirrhosis develop ascites within 10 years of disease onset DAmico et al 2015
Spontaneous bacterial peritonitis SBP which is defined by acute infection of ascitic fluid an abnormal accumulation of fluid in the abdomen without a distinct or identifiable source of infection with ascitic fluid absolute neutrophil count 250 cellsmm³ whether or not there is culture growth is a major cause of morbidity and mortality in cirrhotic patients with ascites SBP is estimated to affect 10-30 of cirrhotic patients hospitalized with ascites and mortality in this group approaches 30 Many of these patients are asymptomatic and it is therefore recommended that all patients with ascites undergo paracentesis at the time of admission to confirm the SBP status Although SBP is less prevalent in an outpatient setting it is reasonable to also evaluate the ascitic fluid of outpatients because of the high mortality associated with SBP Platelets are considered an important source of pro-thrombotic agents associated with inflammatory markers and play a role in the initiation and propagation of inflammatory diseases Platelets with large sizes have many granules that can exert their hemostatic and proinflammatory actions with greater efficiency For these reasons the mean platelet volume MPV and platelet distribution width PDW may be considered indicators of platelet function and activation Abdelmoez et al 2016
MPV and PDW are routine tests that are a part of a complete blood count An increase in MPV has been observed in chronic viral hepatitis because of an increase in the entry of newly produced platelets into circulation which are larger in volume than the old platelets Castellote et al 2008 Suvak et al 2013 Therefore mean platelet volume and platelet distribution width measurement may be used in predicting spontaneous bacterial peritonitis Gálvez-Martínez et al 2015 Abdelmoez et al 2017
The blood neutrophil-lymphocyte ratio NLR is a crucial parameter for the balance of the inflammatory and immune systems reflecting responses to systemic inflammation In patients with decompensated liver cirrhosis NLR is a non-invasive marker that can be used to predict the occurrence of hospital infection Cai et al 2017 NLR is a predictor of SBP that can be utilized in combination with other markers According to Mousa et al 2016 blood NLR 289 had an 803 sensitivity and 889 specificity for diagnosing SBP while blood NLR and CRP combined cut-off 113 mgdL had a 951 sensitivity and 963 specificity Mousa et al 2016
Although single tests have shown some value in predicting SBP their studies have been small and inconsistent In order to predict SBP in patients with cirrhotic ascites prediction scores in conjunction with clinical and laboratory indicators are therefore being developed recently Dahiya et al 2023 Wehmeyer et al 2014
In summary Infections are common in liver cirrhosis patients and SBP is one of the most prevalent with varying frequency but a significant fatality rate One of the most crucial factors in treating this significant consequence of decompensated liver cirrhosis is early detection Finding non-invasive affordable and simple-to-implement parameters related to SBP that have a predictive role is essential However need to be kept in mind these methods cannot completely replace paracentesis more studies are needed to determine whether non-invasive methods are sufficiently accurate to identify the development of SBP in cirrhosis
Spontaneous bacterial peritonitis SBP which is defined by acute infection of ascitic fluid an abnormal accumulation of fluid in the abdomen without a distinct or identifiable source of infection with ascitic fluid absolute neutrophil count 250 cellsmm³ whether or not there is culture growth is a major cause of morbidity and mortality in cirrhotic patients with ascites SBP is estimated to affect 10-30 of cirrhotic patients hospitalized with ascites and mortality in this group approaches 30 Many of these patients are asymptomatic and it is therefore recommended that all patients with ascites undergo paracentesis at the time of admission to confirm the SBP status Although SBP is less prevalent in an outpatient setting it is reasonable to also evaluate the ascitic fluid of outpatients because of the high mortality associated with SBP Platelets are considered an important source of pro-thrombotic agents associated with inflammatory markers and play a role in the initiation and propagation of inflammatory diseases Platelets with large sizes have many granules that can exert their hemostatic and proinflammatory actions with greater efficiency For these reasons the mean platelet volume MPV and platelet distribution width PDW may be considered indicators of platelet function and activation Abdelmoez et al 2016
MPV and PDW are routine tests that are a part of a complete blood count An increase in MPV has been observed in chronic viral hepatitis because of an increase in the entry of newly produced platelets into circulation which are larger in volume than the old platelets Castellote et al 2008 Suvak et al 2013 Therefore mean platelet volume and platelet distribution width measurement may be used in predicting spontaneous bacterial peritonitis Gálvez-Martínez et al 2015 Abdelmoez et al 2017
The blood neutrophil-lymphocyte ratio NLR is a crucial parameter for the balance of the inflammatory and immune systems reflecting responses to systemic inflammation In patients with decompensated liver cirrhosis NLR is a non-invasive marker that can be used to predict the occurrence of hospital infection Cai et al 2017 NLR is a predictor of SBP that can be utilized in combination with other markers According to Mousa et al 2016 blood NLR 289 had an 803 sensitivity and 889 specificity for diagnosing SBP while blood NLR and CRP combined cut-off 113 mgdL had a 951 sensitivity and 963 specificity Mousa et al 2016
Although single tests have shown some value in predicting SBP their studies have been small and inconsistent In order to predict SBP in patients with cirrhotic ascites prediction scores in conjunction with clinical and laboratory indicators are therefore being developed recently Dahiya et al 2023 Wehmeyer et al 2014
In summary Infections are common in liver cirrhosis patients and SBP is one of the most prevalent with varying frequency but a significant fatality rate One of the most crucial factors in treating this significant consequence of decompensated liver cirrhosis is early detection Finding non-invasive affordable and simple-to-implement parameters related to SBP that have a predictive role is essential However need to be kept in mind these methods cannot completely replace paracentesis more studies are needed to determine whether non-invasive methods are sufficiently accurate to identify the development of SBP in cirrhosis
Detailed Description:
None
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