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

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

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 .

Study Overview

• Status: Recruiting
• Conditions: Cirrhotic Patients With Spontaneous Bacterial Peritonitis
• Intervention / Treatment: Diagnostic test: ascetic fluid study

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Mohamed H Mohamed, resident; Phone Number: 01019396460; Email: mohamedhamed@med.sohag.edu.eg
• Study Contact Backup: Name: Asmaa N Mohamed

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag University Hospital
    • Contact: Magdy M Amin, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Asses the value of blood platelets to lymphocytes ratio and monocytes to lymphocytes ratio as predictors of response for the treatment of spontaneous bacterial peritonitis in cirrhotic patients.

Description

Inclusion Criteria:

• Cirrhotic patient with ascites.
• Un treated SBP

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cirrhotic Patients with Spontaneous Bacterial Peritonitis	Diagnostic test: ascetic fluid study; ascetic fluid study parameter in diagnosis of spontaneous bacterial peritpnitis
patient liver cirrhosis (child B,C)
normal individuals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelets to Lymphocytes Ratio and Monocytes to Lymphocytes Ratio as Predictors of Response to Treatment in Cirrhotic Patients with Spontaneous Bacterial Peritonitis	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	19/4/2023 - 30/4/2024

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Song DS. [Spontaneous Bacterial Peritonitis]. Korean J Gastroenterol. 2018 Aug 25;72(2):56-63. doi: 10.4166/kjg.2018.72.2.56. Korean.
• Abdel Hammed MR, El-Amien HA, Asham MN, Elgendy SG. Can platelets indices and blood neutrophil to lymphocyte ratio be used as predictors for diagnosis of spontaneous bacterial peritonitis in decompensated post hepatitis liver cirrhosis? Egypt J Immunol. 2022 Oct;29(4):12-24.
• Chen TM, Lin CC, Huang PT, Wen CF. Neutrophil-to-lymphocyte ratio associated with mortality in early hepatocellular carcinoma patients after radiofrequency ablation. J Gastroenterol Hepatol. 2012 Mar;27(3):553-61. doi: 10.1111/j.1440-1746.2011.06910.x.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2023
• Primary Completion (Anticipated): April 30, 2024
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: April 30, 2023
• First Submitted That Met QC Criteria: April 30, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: April 30, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Peritoneal Diseases; Intraabdominal Infections; Peritonitis
• Other Study ID Numbers: Soh-Med-23-04-11-MS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No