Spontaneous Bacterial PeritonitisNCT07116369
Prediction of SBP in Cirrhotic Patients by Platlet Count, Na and AlBl Index.
An observational study of Spontaneous Bacterial Peritonitis, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to evaluate whether integrating serum sodium levels and platelet count with the Albumin-Bilirubin (ALBI) score can improve the early prediction of spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites. SBP is a common and potentially life-threatening complication of cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Bacterial Peritonitis
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients (≥18 years) with liver cirrhosis and ascites who underwent diagnostic paracentesis in sohag university hospitals
Who may be able to join
- adult patients (≥18 years) with liver cirrhosis and ascites who underwent diagnostic paracentesis.
Who cannot join
- obstructive jaundice
- Recent antibiotic use < 7 days
- Secondary pertonitis (bowel perforation)
- Advanced Hepatocelluar carcinoma
- End-stage renal disease requiring dialysis
- Use of immunosuppressive therapy
- Incomplete laboratory or clinical data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag university hospitals
Sohag
Shimaa H Mahmoud, MBBS, +201120237891, shaimaa_helmy_post@med.sohag.edu.eg
About this study
Official title: Enhancing Prediction of Spontaneous Bacterial Peritonitis in Liver Cirrhosis by Integrating Serum Sodium and Platelet Count With the Albumin-Bilirubin Score .
This study aims to evaluate whether integrating serum sodium levels and platelet count with the Albumin-Bilirubin (ALBI) score can improve the early prediction of spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites. SBP is a common and potentially life-threatening complication of cirrhosis. Identifying at-risk patients early using simple, routine laboratory parameters could enhance risk stratification, guide monitoring strategies, and reduce associated morbidity and mortality.
Participants will be Adult patients (≥18 years) with liver cirrhosis and ascites undergoing diagnostic paracentesis at Sohag University Hospital.
Read the detailed description
This is a prospective observational study designed to enhance the prediction of spontaneous bacterial peritonitis (SBP) in patients with liver cirrhosis and ascites by integrating serum sodium levels and platelet count with the Albumin-Bilirubin (ALBI) score. SBP remains a serious and potentially fatal complication in cirrhotic patients, with delayed diagnosis contributing to poor outcomes. The ALBI score, which reflects liver function objectively, along with hyponatremia and thrombocytopenia-common in cirrhosis-may provide a simple, low-cost method for early identification of patients at high risk for SBP.
The study will be conducted over 6 months at the Internal Medicine and Hepatology Units, Sohag University Hospital. All eligible adult patients (≥18 years) with liver cirrhosis and ascites who undergo diagnostic paracentesis will be screened for inclusion.
Inclusion criteria include cirrhotic patients with ascites undergoing diagnostic paracentesis.
Exclusion criteria include secondary peritonitis, advanced hepatocellular carcinoma, obstructive jaundice, recent antibiotic use (<7 days), end-stage renal disease requiring dialysis, current use of immunosuppressive therapy, and incomplete data.
Each participant will undergo clinical evaluation and laboratory testing, including serum albumin, bilirubin (for ALBI calculation), sodium, and platelet count. Ascitic fluid analysis will be performed to diagnose SBP based on PMN count ≥250 cells/mm³.
The study will assess whether a combined score (ALBI-Na-Platelet) can improve prediction accuracy. Statistical analysis will involve logistic regression and ROC curve analysis to evaluate the predictive power of the combined parameters.
All participants will provide written informed consent. The study is approved by the Medical Ethics Committee of Sohag University, Faculty of Medicine.
- Conditions
- Spontaneous Bacterial Peritonitis
- Keywords
- Spontaneous bacterial peritonitis, SBP, Liver cirrhosis, ABLI score, Ascites
- Medical subject headings
- Liver Cirrhosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ascites patients | >18 yr old Patients with liver cirrhosis and ascites, peritoneal aspirate, ALBI score, plaltlet, serum sodium will be recorded |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of SBP, ALBI score, s.sodium, platelet count
Outcome of SBP in cirrhotic patients by measurement of ALBI score, platelet count and s.sodium
Measured: Within 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Bacterial PeritonitisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Helmy Mahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116369
- Sponsor's protocol ID
- Soh-Med--25-7-10MS
- Status last verified
- Jul 2025
- First submitted
- 25 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Prediction of Spontaneous Bacterial Peritonitis in Liver Cirrhosis by Integrating Serum Sodium and Platelet Count With the Albumin-Bilirubin Score .
- ClinicalTrials.gov ID
- NCT07116369
- Acronym / sponsor ID
- Soh-Med--25-7-10MS
- Conditions
- Spontaneous Bacterial Peritonitis
- Keywords
- Spontaneous bacterial peritonitis, SBP, Liver cirrhosis, ABLI score, Ascites
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate whether integrating serum sodium levels and platelet count with the Albumin-Bilirubin (ALBI) score can improve the early prediction of spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites. SBP is a common and potentially life-threatening complication of cirrhosis. Identifying at-risk patients early using simple, routine laboratory parameters could enhance risk stratification, guide monitoring strategies, and reduce associated morbidity and mortality.
Participants will be Adult patients (≥18 years) with liver cirrhosis and ascites undergoing diagnostic paracentesis at Sohag University Hospital.
Detailed description
This is a prospective observational study designed to enhance the prediction of spontaneous bacterial peritonitis (SBP) in patients with liver cirrhosis and ascites by integrating serum sodium levels and platelet count with the Albumin-Bilirubin (ALBI) score. SBP remains a serious and potentially fatal complication in cirrhotic patients, with delayed diagnosis contributing to poor outcomes. The ALBI score, which reflects liver function objectively, along with hyponatremia and thrombocytopenia-common in cirrhosis-may provide a simple, low-cost method for early identification of patients at high risk for SBP.
The study will be conducted over 6 months at the Internal Medicine and Hepatology Units, Sohag University Hospital. All eligible adult patients (≥18 years) with liver cirrhosis and ascites who undergo diagnostic paracentesis will be screened for inclusion.
Inclusion criteria include cirrhotic patients with ascites undergoing diagnostic paracentesis.
Exclusion criteria include secondary peritonitis, advanced hepatocellular carcinoma, obstructive jaundice, recent antibiotic use (<7 days), end-stage renal disease requiring dialysis, current use of immunosuppressive therapy, and incomplete data.
Each participant will undergo clinical evaluation and laboratory testing, including serum albumin, bilirubin (for ALBI calculation), sodium, and platelet count. Ascitic fluid analysis will be performed to diagnose SBP based on PMN count ≥250 cells/mm³.
The study will assess whether a combined score (ALBI-Na-Platelet) can improve prediction accuracy. Statistical analysis will involve logistic regression and ROC curve analysis to evaluate the predictive power of the combined parameters.
All participants will provide written informed consent. The study is approved by the Medical Ethics Committee of Sohag University, Faculty of Medicine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ascites patients | – | –>18 yr old Patients with liver cirrhosis and ascites, peritoneal aspirate, ALBI score, plaltlet, serum sodium will be recorded |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients (≥18 years) with liver cirrhosis and ascites who underwent diagnostic paracentesis in sohag university hospitals
Key inclusion criteria (1 listed)
- adult patients (≥18 years) with liver cirrhosis and ascites who underwent diagnostic paracentesis.
Key exclusion criteria (7 listed)
- obstructive jaundice
- Recent antibiotic use < 7 days
- Secondary pertonitis (bowel perforation)
- Advanced Hepatocelluar carcinoma
- End-stage renal disease requiring dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of SBP, ALBI score, s.sodium, platelet count
Time frame: Within 1 week
Outcome of SBP in cirrhotic patients by measurement of ALBI score, platelet count and s.sodium
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Bacterial Peritonitis, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shimaa H Mahmoud, MBBS (+201120237891, shaimaa_helmy_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of SBP, ALBI score, s.sodium, platelet count (time frame: Within 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.