CirrhosisNCT06884306
Predictors of Spontaneous Bacterial Peritonitis Among Patients with Cirrhosis
An observational study of Cirrhosis, run by Assiut University.
Trial summary
Prevalence of spontaneous bacterial peritonitis (SBP) varies from approximately 4% among asymptomatic patients to 30% among those hospitalized [1, 2].Previous studies explored the role of several biomarkers, such as tumor necrosis factor-α, procalcitonin, and fecal calprotectin, for prediction of SBP The NLR is… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 Jul 2026
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cirrhotic patients with Moderate-marked ascites, as determined by abdominal ultrasonography (US). SBP will be diagnosed based on detection of polymorph nuclear leukocytes (PMNs) >250 cells/mcL and/or white blood cells (WBCs) >500 cells/mcL by ascitic fluid examination.
Who may be able to join
- include cirrhotic patients with Moderate-marked ascites, as determined by abdominal ultrasonography (US). SBP will be diagnosed based on detection of polymorph nuclear leukocytes (PMNs) >250 cells/mcL and/or white blood cells (WBCs) >500 cells/mcL by ascitic fluid examination.
Who cannot join
- 1- Pediatric patients (less than 18 years old) and patients older than 70 years Pregnant patients .
- 2-Etiology of ascites other than cirrhosis. 3-Receiving antibiotics and/or prophylaxis four weeks before admission. 4- Concurrent bacterial infection other than SBP. 5- Abdominal surgery 12 weeks before admission 6-Patients with neoplastic or hematological disease. 7- Patients who received bone marrow transplantation, chemotherapy, or radiotherapy four weeks before admission.
- 8- Conditions associated with increased MPV such as systemic hypertension, diabetes mellitus, dyslipidemia, peripheral vascular disease, thyroid disease, and therapy four weeks before admission with antiplatelet agents and nonsteroidal anti-inflammatory drugs
About this study
Prevalence of spontaneous bacterial peritonitis (SBP) varies from approximately 4% among asymptomatic patients to 30% among those hospitalized [1, 2].Previous studies explored the role of several biomarkers, such as tumor necrosis factor-α, procalcitonin, and fecal calprotectin, for prediction of SBP The NLR is speculated to reflect immune regulatory mechanism (lymphocytes) and ongoing inflammation (neutrophils) . Assessing the diagnostic value of NLR for liver disease has gained particular interest, namely, among patients with nonalcoholic fatty liver disease and hepatocellular carcinoma . Direct interaction between platelets and bacteria lead to platelet activation . Platelet activation leads to change of platelet shape with increase in platelet size and anisocytosis, and consequent increase in both mean platelet volume (MPV) and platelet distribution width (PDW) .Acute phase reactants, such as C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), are elevated among patients with SBP, as a result of cytokine synthesis . Older patients, due to higher possibility of advanced liver disease and more frequent comorbidity, are more susceptible to SBP .
The Department of Tropical Medicine (Mansoura University) developed a simple scoring system for prediction of SBP among cirrhotic patients with ascites, which include four variables: age, MPV, NLR, and C-reactive protein (CRP) . The independent predictors of SBP were age of at least 55 years, MPV of at least 8.5 fL, NLR of at least 2.5, and CRP of at least 40 mg/dL . The progression of hospitalized patients with SBP can lead to an in-hospital mortality rate of approximately 17% .
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Therefore, the sequelae of SBP highlight the increasing value of establishing reliable diagnostic biomarkers. The earlier the diagnosis, the lower the mortality rate.To our knowledge, only one, national study utilized MPV, NLR, and CRP for prediction of SBP among cirrhotic patients with ascites [3].We intend to further extend both the diagnostic utilities (by adding ESR to the previously mentioned tools) and the spectrum of prediction, to include mortality in addition to the development of SBP among cirrhotic patients with ascites.
The study aims at developing a local scoring system (RSS) for the prediction of SBP and its related mortality among cirrhotic patients with ascites admitted to Al-Rajhy Liver Hospital (Assiut University).
Our objective is to compare age, NLR, MPV, PDW, and CRP between cirrhotic patients with ascites complicated with SBP and those without SBP, and between surviving SBP patients compared to those with in-hospital mortality.
- Conditions
- Cirrhosis
- Medical subject headings
- Fibrosis
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 |
|---|---|---|
| study group | cirrhotic patients with Moderate-marked ascites, as determined by abdominal ultrasonography (US). SBP will be diagnosed based on detection of polymorph nuclear leukocytes (PMNs) >250 cells/mcL and/or white blood cells (WBCs) >500 cells/mcL by ascitic fluid examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
local scoring system (RSS)
developing a local scoring system (RSS) for the prediction of SBP mortality among cirrhotic patients with ascites admitted to Al-Rajhy Liver Hospital (Assiut University
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Nashaat Mohamed Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884306
- Sponsor's protocol ID
- SBP Cirrhosis
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Spontaneous Bacterial Peritonitis Among Patients with Cirrhosis
- ClinicalTrials.gov ID
- NCT06884306
- Acronym / sponsor ID
- SBP Cirrhosis
- Conditions
- Cirrhosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 19 Mar 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.
Prevalence of spontaneous bacterial peritonitis (SBP) varies from approximately 4% among asymptomatic patients to 30% among those hospitalized [1, 2].Previous studies explored the role of several biomarkers, such as tumor necrosis factor-α, procalcitonin, and fecal calprotectin, for prediction of SBP The NLR is speculated to reflect immune regulatory mechanism (lymphocytes) and ongoing inflammation (neutrophils) . Assessing the diagnostic value of NLR for liver disease has gained particular interest, namely, among patients with nonalcoholic fatty liver disease and hepatocellular carcinoma . Direct interaction between platelets and bacteria lead to platelet activation . Platelet activation leads to change of platelet shape with increase in platelet size and anisocytosis, and consequent increase in both mean platelet volume (MPV) and platelet distribution width (PDW) .Acute phase reactants, such as C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), are elevated among patients with SBP, as a result of cytokine synthesis . Older patients, due to higher possibility of advanced liver disease and more frequent comorbidity, are more susceptible to SBP .
The Department of Tropical Medicine (Mansoura University) developed a simple scoring system for prediction of SBP among cirrhotic patients with ascites, which include four variables: age, MPV, NLR, and C-reactive protein (CRP) . The independent predictors of SBP were age of at least 55 years, MPV of at least 8.5 fL, NLR of at least 2.5, and CRP of at least 40 mg/dL . The progression of hospitalized patients with SBP can lead to an in-hospital mortality rate of approximately 17% .
Therefore, the sequelae of SBP highlight the increasing value of establishing reliable diagnostic biomarkers. The earlier the diagnosis, the lower the mortality rate.To our knowledge, only one, national study utilized MPV, NLR, and CRP for prediction of SBP among cirrhotic patients with ascites [3].We intend to further extend both the diagnostic utilities (by adding ESR to the previously mentioned tools) and the spectrum of prediction, to include mortality in addition to the development of SBP among cirrhotic patients with ascites.
The study aims at developing a local scoring system (RSS) for the prediction of SBP and its related mortality among cirrhotic patients with ascites admitted to Al-Rajhy Liver Hospital (Assiut University).
Our objective is to compare age, NLR, MPV, PDW, and CRP between cirrhotic patients with ascites complicated with SBP and those without SBP, and between surviving SBP patients compared to those with in-hospital mortality.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –cirrhotic patients with Moderate-marked ascites, as determined by abdominal ultrasonography (US). SBP will be diagnosed based on detection of polymorph nuclear leukocytes (PMNs) >250 cells/mcL and/or white blood cells (WBCs) >500 cells/mcL by ascitic fluid examination. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cirrhotic patients with Moderate-marked ascites, as determined by abdominal ultrasonography (US). SBP will be diagnosed based on detection of polymorph nuclear leukocytes (PMNs) >250 cells/mcL and/or white blood cells (WBCs) >500 cells/mcL by ascitic fluid examination.
Key inclusion criteria (1 listed)
- include cirrhotic patients with Moderate-marked ascites, as determined by abdominal ultrasonography (US). SBP will be diagnosed based on detection of polymorph nuclear leukocytes (PMNs) >250 cells/mcL and/or white blood cells (WBCs) >500 cells/mcL by ascitic fluid examination.
Key exclusion criteria (3 listed)
- 1- Pediatric patients (less than 18 years old) and patients older than 70 years Pregnant patients .
- 2-Etiology of ascites other than cirrhosis. 3-Receiving antibiotics and/or prophylaxis four weeks before admission. 4- Concurrent bacterial infection other than SBP. 5- Abdominal surgery 12 weeks before admission 6-Patients with neoplastic or hematological disease. 7- Patients who received bone marrow transplantation, chemotherapy, or radiotherapy four weeks before admission.
- 8- Conditions associated with increased MPV such as systemic hypertension, diabetes mellitus, dyslipidemia, peripheral vascular disease, thyroid disease, and therapy four weeks before admission with antiplatelet agents and nonsteroidal anti-inflammatory drugs
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
local scoring system (RSS)
Time frame: baseline
developing a local scoring system (RSS) for the prediction of SBP mortality among cirrhotic patients with ascites admitted to Al-Rajhy Liver Hospital (Assiut University
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 19 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, run by Assiut University.
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 3 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 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local scoring system (RSS) (time frame: baseline). 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 19 Mar 2025.