Platelets to Lymphocytes Ratio and Monocytes to Lymphocytes Ratio as Predictors of Response to Treatment in Cirrhotic Patients With Spontaneous Bacterial Peritonitis.

Recruiting

• Conditions: Cirrhotic Patients With Spontaneous Bacterial Peritonitis
• Interventions: Diagnostic Test: ascetic fluid study

• Registration Number: NCT05850858
• Lead Sponsor: Sohag University

Brief Summary

Spontaneous bacterial peritonitis (SBP) is a serious complication of ascites that can lead to death and can be described as an acute infection of ascites without any certain source of infection SBP is considered the most common infection in cirrhotic patients with ascites. SBP is diagnosed by the presence of ≥250 polymorphonuclear leukocyte (PMNL)/mm3 in the ascetic fluid in absence of surgical and treatable causes of intra-abdominal infections .

SBP has many pictures of clinical presentation SBP can be asymptomatic and patients pass unnoticed or can discovered accidentally may have local symptoms and signs of peritonitis such as abdominal pain, and tachypnea or may present with signs of deteriorated liver function in form of gastrointestinal bleeding, shock and renal failure An increasing amount of studies have demonstrated that peripheral blood neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR), platelet-to-lymphocyte ratio (PLR) are indicators of systematic inflammatory response and are widely investigated as useful predictors of the clinical outcomes in various diseases .

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2023-04
• Study Start: 2023-04-19
• Study First Submitted: 2023-04-30
• Study First Submitted QC: 2023-04-30
• Last Update Submitted: 2023-04-30
• Study First Posted: 2023-05-09
• Last Update Posted: 2023-05-09
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Cirrhotic patient with ascites.
• Un treated SBP

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Exclusion Criteria

• Ascites without cirrhosis (malignant ascites, chylous ascites, etc...).
• Tuberculous peritonitis.
• Secondary bacterial peritonitis due to any surgical cause.
• Sepsis rather than SBP.
• Patients with unrelated infections e.g. skin, chest infection, etc.
• Patients started treatment of SBP.
• Patients on prophylactic antibiotics for recurrent SBP prevention .
• Patients declining to provide informed consent.
• Patients with hepatocellular carcinoma on top of cirrhosis.
• Patients with other malignancy or any immunological disease

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cirrhotic Patients with Spontaneous Bacterial Peritonitis	ascetic fluid study	-

Primary Outcome Measures

Name	Time	Method
Platelets to Lymphocytes Ratio and Monocytes to Lymphocytes Ratio as Predictors of Response to Treatment in Cirrhotic Patients with Spontaneous Bacterial Peritonitis	19/4/2023 - 30/4/2024	Spontaneous bacterial peritonitis (SBP) is a serious complication of ascites that can lead to death and can be described as an acute infection of ascites without any certain source of infection SBP is considered the most common infection in cirrhotic patients with ascites. SBP is diagnosed by the presence of ≥250 polymorphonuclear leukocyte (PMNL)/mm3 in the ascetic fluid in absence of surgical and treatable causes of intra-abdominal infections SBP has many pictures of clinical presentation SBP can be asymptomatic and patients pass unnoticed or can discovered accidentally may have local symptoms and signs of peritonitis such as abdominal pain, and tachypnea or may present with signs of deteriorated liver function in form of gastrointestinal bleeding, shock and renal failure

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt