Cirrhotic Ascitic PatientsNCT06402071
Clinical Value of the Developed Scoring Systems for Predicting Spontaneous Bacterial Peritonitis in Cirrhotic Ascites
An observational study of Cirrhotic Ascitic Patients, run by Dalia Nasser Mohamed at 1 site in Egypt.
Trial summary
Liver cirrhosis is the clinical end stage of different entities of chronic liver disease when patients suffer from considerable mortality and morbidity, both of which are correlated positively with disease severity. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cirrhotic Ascitic Patients
- What is being tested?
- Ascitic fluid study
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This case control study will include Patients with liver cirrhosis diagnosed by combination of clinical, sonographic and laboratory data admitted to Sohag University hospital with ascites with or without evidence of ascitic fluid infection. According to the ascitic fluid analysis patients will be divided according to the polymorphnuclear cells count in the ascitic fluid into two groups: 1. Group I: will include cirrhotic ascitic patients with SBP. 2. Group II: will include age matched ci
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Safaa Kh Abdallah, Assistant professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university hospitals
Sohag
Magdy M Amin, Professor
About this study
Liver cirrhosis is the clinical end stage of different entities of chronic liver disease when patients suffer from considerable mortality and morbidity, both of which are correlated positively with disease severity. Ascites are the most common complication, and around 60% of patients with compensated cirrhosis develop ascites within 10 years of disease onset (D'Amico et al., 2015).
Spontaneous bacterial peritonitis (SBP) which is defined by acute infection of ascitic fluid, an abnormal accumulation of fluid in the abdomen without a distinct or identifiable source of infection, with ascitic fluid absolute neutrophil count >250 cells/mm³, whether or not there is culture growth. is a major cause of morbidity and mortality in cirrhotic patients with ascites. SBP is estimated to affect 10-30% of cirrhotic patients hospitalized with ascites, and mortality in this group approaches 30%. Many of these patients are asymptomatic, and it is therefore recommended that all patients with ascites undergo paracentesis at the time of admission to confirm the SBP status. Although SBP is less prevalent in an outpatient setting, it is reasonable to also evaluate the ascitic fluid of outpatients because of the high mortality associated with SBP Platelets are considered an important source of pro-thrombotic agents associated with inflammatory markers and play a role in the initiation and propagation of inflammatory diseases. Platelets with large sizes have many granules that can exert their hemostatic and proinflammatory actions with greater efficiency. For these reasons, the mean platelet volume (MPV) and platelet distribution width (PDW) may be considered indicators of platelet function and activation (Abdelmoez et al., 2016).
Read more
MPV and PDW are routine tests that are a part of a complete blood count. An increase in MPV has been observed in chronic viral hepatitis because of an increase in the entry of newly produced platelets into circulation, which are larger in volume than the old platelets (Castellote et al., 2008; Suvak et al., 2013). Therefore, mean platelet volume and platelet distribution width measurement may be used in predicting spontaneous bacterial peritonitis (Gálvez-Martínez et al., 2015; Abdelmoez et al., 2017).
The blood neutrophil-lymphocyte ratio (NLR) is a crucial parameter for the balance of the inflammatory and immune systems, reflecting responses to systemic inflammation In patients with decompensated liver cirrhosis, NLR is a non-invasive marker that can be used to predict the occurrence of hospital infection (Cai et al., 2017), NLR is a predictor of SBP that can be utilized in combination with other markers. According to (Mousa et al., 2016), blood NLR > 2.89 had an 80.3% sensitivity and 88.9% specificity for diagnosing SBP, while blood NLR and CRP combined (cut-off 11.3 mg/dL) had a 95.1% sensitivity and 96.3% specificity (Mousa et al., 2016).
Although single tests have shown some value in predicting SBP, their studies have been small and inconsistent. In order to predict SBP in patients with cirrhotic ascites, prediction scores in conjunction with clinical and laboratory indicators are therefore being developed recently (Dahiya et al., 2023; Wehmeyer et al., 2014).
In summary, Infections are common in liver cirrhosis patients, and SBP is one of the most prevalent, with varying frequency but a significant fatality rate. One of the most crucial factors in treating this significant consequence of decompensated liver cirrhosis is early detection. Finding non-invasive, affordable, and simple-to-implement parameters related to SBP that have a predictive role is essential. However, need to be kept in mind these methods cannot completely replace paracentesis, more studies are needed to determine whether non-invasive methods are sufficiently accurate to identify the development of SBP in cirrhosis.
- Conditions
- Cirrhotic Ascitic Patients
- Being tested
- Ascitic fluid study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascitic fluid studyDiagnostic test
Also called Abdominal ultrasound, liver functions
Ascitic fluid study will be obtained from all participants
| Study group | Role | What they receive |
|---|---|---|
| Group A (Cases) | Cirrhotic ascitic patients with spontaneous bacterial peritonitis Receives: Diagnostic Test: Ascitic fluid study | |
| Group B (Controls) | Cirrhotic ascitic patients without spontaneous bacterial peritonitis Receives: Diagnostic Test: Ascitic fluid study |
What is being measured
The primary outcome is the main question the study is designed to answer.
-Determine the cases of SBP among all cirrhotic patients with ascites
compare role of markers of systemic inflammatory response individually or built in model scores as non- invasive predictors for SBP
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 May 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cirrhotic Ascitic PatientsStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalia Nasser Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dalia Nasser Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402071
- Sponsor's protocol ID
- Soh-Med-24-03-05MS
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Galvez-Martinez M, Servin-Caamano AI, Perez-Torres E, Salas-Gordillo F, Rivera-Gutierrez X, Higuera-de la Tijera F. Mean platelet volume as a novel predictor of systemic inflammatory response in cirrhotic patients with culture-negative neutrocytic ascites. World J Hepatol. 2015 May 8;7(7):1001-6. doi: 10.4254/wjh.v7.i7.1001.
PubMed 25954482Wehmeyer MH, Krohm S, Kastein F, Lohse AW, Luth S. Prediction of spontaneous bacterial peritonitis in cirrhotic ascites by a simple scoring system. Scand J Gastroenterol. 2014 May;49(5):595-603. doi: 10.3109/00365521.2013.848471. Epub 2014 Mar 27.
PubMed 24673156Abdel-Razik A, Mousa N, Besheer TA, Eissa M, Elhelaly R, Arafa M, El-Wakeel N, Eldars W. Neutrophil to lymphocyte ratio as a reliable marker to predict insulin resistance and fibrosis stage in chronic hepatitis C virus infection. Acta Gastroenterol Belg. 2015 Dec;78(4):386-92.
PubMed 26712048Metwally K, Fouad T, Assem M, Abdelsameea E, Yousery M. Predictors of Spontaneous Bacterial Peritonitis in Patients with Cirrhotic Ascites. J Clin Transl Hepatol. 2018 Dec 28;6(4):372-376. doi: 10.14218/JCTH.2018.00001. Epub 2018 Jul 18.
PubMed 30637213
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of the Developed Scoring Systems for Predicting Spontaneous Bacterial Peritonitis in Cirrhotic Ascites
- ClinicalTrials.gov ID
- NCT06402071
- Acronym / sponsor ID
- Soh-Med-24-03-05MS
- Conditions
- Cirrhotic Ascitic Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dalia Nasser MohamedUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 7 May 2024 (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.
Liver cirrhosis is the clinical end stage of different entities of chronic liver disease when patients suffer from considerable mortality and morbidity, both of which are correlated positively with disease severity. Ascites are the most common complication, and around 60% of patients with compensated cirrhosis develop ascites within 10 years of disease onset (D'Amico et al., 2015).
Spontaneous bacterial peritonitis (SBP) which is defined by acute infection of ascitic fluid, an abnormal accumulation of fluid in the abdomen without a distinct or identifiable source of infection, with ascitic fluid absolute neutrophil count >250 cells/mm³, whether or not there is culture growth. is a major cause of morbidity and mortality in cirrhotic patients with ascites. SBP is estimated to affect 10-30% of cirrhotic patients hospitalized with ascites, and mortality in this group approaches 30%. Many of these patients are asymptomatic, and it is therefore recommended that all patients with ascites undergo paracentesis at the time of admission to confirm the SBP status. Although SBP is less prevalent in an outpatient setting, it is reasonable to also evaluate the ascitic fluid of outpatients because of the high mortality associated with SBP Platelets are considered an important source of pro-thrombotic agents associated with inflammatory markers and play a role in the initiation and propagation of inflammatory diseases. Platelets with large sizes have many granules that can exert their hemostatic and proinflammatory actions with greater efficiency. For these reasons, the mean platelet volume (MPV) and platelet distribution width (PDW) may be considered indicators of platelet function and activation (Abdelmoez et al., 2016).
MPV and PDW are routine tests that are a part of a complete blood count. An increase in MPV has been observed in chronic viral hepatitis because of an increase in the entry of newly produced platelets into circulation, which are larger in volume than the old platelets (Castellote et al., 2008; Suvak et al., 2013). Therefore, mean platelet volume and platelet distribution width measurement may be used in predicting spontaneous bacterial peritonitis (Gálvez-Martínez et al., 2015; Abdelmoez et al., 2017).
The blood neutrophil-lymphocyte ratio (NLR) is a crucial parameter for the balance of the inflammatory and immune systems, reflecting responses to systemic inflammation In patients with decompensated liver cirrhosis, NLR is a non-invasive marker that can be used to predict the occurrence of hospital infection (Cai et al., 2017), NLR is a predictor of SBP that can be utilized in combination with other markers. According to (Mousa et al., 2016), blood NLR > 2.89 had an 80.3% sensitivity and 88.9% specificity for diagnosing SBP, while blood NLR and CRP combined (cut-off 11.3 mg/dL) had a 95.1% sensitivity and 96.3% specificity (Mousa et al., 2016).
Although single tests have shown some value in predicting SBP, their studies have been small and inconsistent. In order to predict SBP in patients with cirrhotic ascites, prediction scores in conjunction with clinical and laboratory indicators are therefore being developed recently (Dahiya et al., 2023; Wehmeyer et al., 2014).
In summary, Infections are common in liver cirrhosis patients, and SBP is one of the most prevalent, with varying frequency but a significant fatality rate. One of the most crucial factors in treating this significant consequence of decompensated liver cirrhosis is early detection. Finding non-invasive, affordable, and simple-to-implement parameters related to SBP that have a predictive role is essential. However, need to be kept in mind these methods cannot completely replace paracentesis, more studies are needed to determine whether non-invasive methods are sufficiently accurate to identify the development of SBP in cirrhosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Cases) | – | Diagnostic Test: Ascitic fluid studyCirrhotic ascitic patients with spontaneous bacterial peritonitis |
| Group B (Controls) | – | Diagnostic Test: Ascitic fluid studyCirrhotic ascitic patients without spontaneous bacterial peritonitis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This case control study will include Patients with liver cirrhosis diagnosed by combination of clinical, sonographic and laboratory data admitted to Sohag University hospital with ascites with or without evidence of ascitic fluid infection. According to the ascitic fluid analysis patients will be divided according to the polymorphnuclear cells count in the ascitic fluid into two groups: 1. Group I: will include cirrhotic ascitic patients with SBP. 2. Group II: will include age matched ci
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascitic fluid studyAlso: Abdominal ultrasound, liver functionsAscitic fluid study will be obtained from all participants | Diagnostic test | Group A (Cases), Group B (Controls) |
Primary outcome
-Determine the cases of SBP among all cirrhotic patients with ascites
Time frame: 1 year
compare role of markers of systemic inflammatory response individually or built in model scores as non- invasive predictors for SBP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Background: PubMed 25954482Galvez-Martinez M, Servin-Caamano AI, Perez-Torres E, Salas-Gordillo F, Rivera-Gutierrez X, Higuera-de la Tijera F. Mean platelet volume as a novel predictor of systemic inflammatory response in cirrhotic patients with culture-negative neutrocytic ascites. World J Hepatol. 2015 May 8;7(7):1001-6. doi: 10.4254/wjh.v7.i7.1001.
- Background: PubMed 24673156Wehmeyer MH, Krohm S, Kastein F, Lohse AW, Luth S. Prediction of spontaneous bacterial peritonitis in cirrhotic ascites by a simple scoring system. Scand J Gastroenterol. 2014 May;49(5):595-603. doi: 10.3109/00365521.2013.848471. Epub 2014 Mar 27.
- Background: PubMed 26712048Abdel-Razik A, Mousa N, Besheer TA, Eissa M, Elhelaly R, Arafa M, El-Wakeel N, Eldars W. Neutrophil to lymphocyte ratio as a reliable marker to predict insulin resistance and fibrosis stage in chronic hepatitis C virus infection. Acta Gastroenterol Belg. 2015 Dec;78(4):386-92.
- Background: PubMed 30637213Metwally K, Fouad T, Assem M, Abdelsameea E, Yousery M. Predictors of Spontaneous Bacterial Peritonitis in Patients with Cirrhotic Ascites. J Clin Transl Hepatol. 2018 Dec 28;6(4):372-376. doi: 10.14218/JCTH.2018.00001. Epub 2018 Jul 18.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
Safaa Kh Abdallah, Assistant professor contact
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 Cirrhotic Ascitic Patients, run by Dalia Nasser Mohamed 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: status not confirmed, as of the sponsor's last update on 7 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalia N Mohammed (01124970357, dalia.naser@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
-Determine the cases of SBP among all cirrhotic patients with ascites (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06402071, which also lists 4 linked publications.
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 7 May 2024.