Clinical trial NCT05850858: Platelets to Lymphocytes Ratio and Monocytes to Lymphocytes Ratio as Predictors of Response to Treatment in Cirrhotic Patients With Spontaneous Bacterial Peritonitis.
Official title: Platelets to Lymphocytes Ratio and Monocytes to Lymphocytes Ratio as Predictors of Response to Treatment in Cirrhotic Patients With Spontaneous Bacterial Peritonitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cirrhotic Patients With Spontaneous Bacterial Peritonitis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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 .


Eligibility criteria: 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

Primary outcomes:
measure: Platelets to Lymphocytes Ratio and Monocytes to Lymphocytes Ratio as Predictors of Response to Treatment in Cirrhotic Patients with Spontaneous Bacterial Peritonitis
timeFrame: 19/4/2023 - 30/4/2024
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Song DS. [Spontaneous Bacterial Peritonitis]. Korean J Gastroenterol. 2018 Aug 25;72(2):56-63. doi: 10.4166/kjg.2018.72.2.56. Korean.
citation: 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.
citation: 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.