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Status unknownNCT05850858Updated May 9, 2023

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

An observational study in Cirrhotic Patients With Spontaneous Bacterial Peritonitis, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to participants aged 15 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-05-09.

Sponsored by Sohag University · Observational

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
300
Ages
15 Years to 100 Years
Sex
All
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Study 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 .

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Conditions studied

  • Cirrhotic Patients With Spontaneous Bacterial Peritonitis

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In context

Peritonitis

185 studies on the registry are indexed under Peritonitis; 25 are open to participants now.

This study's planned enrollment of 300 is above the median of 127 across 59 observational studies indexed under Peritonitis.

Browse Peritonitis studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 100 Years
Sexes eligible
All
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.

Inclusion criteria

  • Cirrhotic patient with ascites.
  • Un treated SBP

Exclusion criteria

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

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cirrhotic Patients with Spontaneous Bacterial Peritonitis

    Diagnostic Test: ascetic fluid study

  • patient liver cirrhosis (child B,C)
  • normal individuals

Interventions

  • Diagnostic testascetic fluid study

    ascetic fluid study parameter in diagnosis of spontaneous bacterial peritpnitis

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 19/4/2023 - 30/4/2024

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Study locations

1 of 1 sites recruiting
  • Sohag University Hospital
    Sohag, Egypt
    • magdy m amin, professor · Contact
    Recruiting
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References and documents

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. PubMed 30145857 ↗
  • 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. PubMed 36197150 ↗
  • 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. PubMed 21913982 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05850858
Lead sponsor
Sohag University
Responsible party
Mohamed Hamed Mohamed (Platelets to Lymphocytes Ratio and Monocytes to Lymphocytes Ratio as Predictors of Response to Treatment in Cirrhotic Patients with Spontaneous Bacterial Peritonitis, Sohag University) — Principal investigator
First posted
May 9, 2023
Start date
Apr 19, 2023
Primary completion
Apr 30, 2024 (estimated)
Completion
Apr 30, 2024 (estimated)
Last update
May 9, 2023

Study contacts

Mohamed H Mohamed, resident
Contact
mohamedhamed@med.sohag.edu.eg
01019396460
Asmaa N Mohamed
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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