Assessing scoring systems for predicting infections in patients with liver cirrhosis and ascites
Clinical Value of the Developed Scoring Systems for Predicting Spontaneous Bacterial Peritonitis in Cirrhotic Ascites
This study is trying to see if certain scoring systems can help predict infections in people with liver cirrhosis and fluid buildup in their abdomen.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag) |
| Trial ID | NCT06402071 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical value of developed scoring systems to predict spontaneous bacterial peritonitis (SBP) in patients suffering from cirrhotic ascites. It will include all cirrhotic patients with ascites, regardless of whether they currently have SBP, defined by specific criteria related to ascitic fluid analysis. The study will analyze the relationship between disease severity and the occurrence of SBP, which is a significant cause of morbidity and mortality in this patient population. By identifying patients at risk for SBP, the study seeks to improve management and outcomes for those with cirrhotic ascites.
Who should consider this trial
Good fit: Ideal candidates for this study are cirrhotic patients with ascites, with or without spontaneous bacterial peritonitis.
Not a fit: Patients with ascites due to causes other than cirrhosis or those with certain infections or inflammatory conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better prediction and management of spontaneous bacterial peritonitis in cirrhotic patients, potentially reducing morbidity and mortality.
How similar studies have performed: While there is existing literature on spontaneous bacterial peritonitis, this specific scoring system approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All cirrhotic patients with ascites with or without spontaneous bacterial peritonitis, SBP that is defined as ascites PMN count \>250 cells /mm3, without evidence of inta-abdominal surgical cause of infection) will be included in the study. Exclusion Criteria: * Patients with ascites because of causes other than cirrhosis, such as renal, cardiac, nutritional, tuberculosis, peritoneal carcinomatosis. If there is evidence of intra or extrahepatic malignancy. If there is evidence of other non-infectious inflammatory conditions like rheumatoid arthritis, ankylosing spondylitis and /or auto immune diseases. If there are infections other than SBP, such as pneumonia, urinary tract infection, and skin infection. Patients receiving anticoagulants, oral contraception or NSAIDs before hospital admission. Patients on recent usage of antibiotics prior to hospital admission. If there is evidence of monomicrobial non-neutrocytic bacterascites when PMNL count is \<250/mm3 and the culture positive while the patient may present with symptoms and signs of infection. Patients with secondary peritonitis which is described as the presence of a very high PMNL count with a lack of response to antibiotic treatment or glucose level in ascitic fluid \<50 mg/dl, protein \>10 g/l or suspected intraabdominal surgical cause of infection. Patients with diseases associated with increased MPV, for example, diabetes mellitus, cardiovascular disease, hyperthyroidism, immune thrombocytopenia, and myeloproliferative disease.
Where this trial is running
Sohag
- Sohag university hospitals — Sohag, Egypt (Recruiting)
Study contacts
- Study coordinator: Dalia N Mohammed
- Email: dalia.naser@med.sohag.edu.eg
- Phone: 01124970357
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.