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

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05850858
Collaborator
(none)
300
1
12.4
24.2

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ascetic fluid study

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Platelets to Lymphocytes Ratio and Monocytes to Lymphocytes Ratio as Predictors of Response to Treatment in Cirrhotic Patients With Spontaneous Bacterial Peritonitis
Actual Study Start Date :
Apr 19, 2023
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University Hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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
ClinicalTrials.gov Identifier:
NCT05850858
Other Study ID Numbers:
  • Soh-Med-23-04-11-MS
First Posted:
May 9, 2023
Last Update Posted:
May 9, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 9, 2023