Cirrhotic Patients With Spontaneous Bacterial PeritonitisNCT05850858
Platelets to Lymphocytes Ratio and Monocytes to Lymphocytes Ratio as Predictors of Response to Treatment in Cirrhotic Patients With Spontaneous Bacterial Peritonitis.
An observational study of Cirrhotic Patients With Spontaneous Bacterial Peritonitis, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 100 years
- Conditions the study is for
- Cirrhotic Patients With Spontaneous Bacterial Peritonitis
- What is being tested?
- ascetic fluid study
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Apr 2023to 30 Apr 2024
- 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 15 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Asses the value of blood platelets to lymphocytes ratio and monocytes to lymphocytes ratio as predictors of response for the treatment of spontaneous bacterial peritonitis in cirrhotic patients.
Who may be able to join
- Cirrhotic patient with ascites.
- Un treated SBP
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Asmaa N Mohamed contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
magdy m amin, professor
About this study
Official title: Platelets to Lymphocytes Ratio and Monocytes to Lymphocytes Ratio as Predictors of Response to Treatment in Cirrhotic Patients With Spontaneous Bacterial Peritonitis
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 .
- Being tested
- ascetic fluid study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ascetic fluid studyDiagnostic test
ascetic fluid study parameter in diagnosis of spontaneous bacterial peritpnitis
| Study group | Role | What they receive |
|---|---|---|
| Cirrhotic Patients with Spontaneous Bacterial Peritonitis | Not described Receives: Diagnostic Test: ascetic fluid study | |
| patient liver cirrhosis (child B,C) | Not described | |
| normal individuals | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelets to Lymphocytes Ratio and Monocytes to Lymphocytes Ratio as Predictors of Response to Treatment in Cirrhotic Patients with Spontaneous Bacterial Peritonitis
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
Measured: 19/4/2023 - 30/4/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start19 Apr 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cirrhotic Patients With 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hamed Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850858
- Sponsor's protocol ID
- Soh-Med-23-04-11-MS
- Status last verified
- Apr 2023
- First submitted
- 30 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Song DS. [Spontaneous Bacterial Peritonitis]. Korean J Gastroenterol. 2018 Aug 25;72(2):56-63. doi: 10.4166/kjg.2018.72.2.56. Korean.
PubMed 30145857Abdel Hammed MR, El-Amien HA, Asham MN, Elgendy SG. Can platelets indices and blood neutrophil to lymphocyte ratio be used as predictors for diagnosis of spontaneous bacterial peritonitis in decompensated post hepatitis liver cirrhosis? Egypt J Immunol. 2022 Oct;29(4):12-24.
PubMed 36197150Chen TM, Lin CC, Huang PT, Wen CF. Neutrophil-to-lymphocyte ratio associated with mortality in early hepatocellular carcinoma patients after radiofrequency ablation. J Gastroenterol Hepatol. 2012 Mar;27(3):553-61. doi: 10.1111/j.1440-1746.2011.06910.x.
PubMed 21913982
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelets to Lymphocytes Ratio and Monocytes to Lymphocytes Ratio as Predictors of Response to Treatment in Cirrhotic Patients With Spontaneous Bacterial Peritonitis
- ClinicalTrials.gov ID
- NCT05850858
- Acronym / sponsor ID
- Soh-Med-23-04-11-MS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 9 May 2023 (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.
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 .
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cirrhotic Patients with Spontaneous Bacterial Peritonitis | – | Diagnostic Test: ascetic fluid study |
| patient liver cirrhosis (child B,C) | – | – |
| normal individuals | – | – |
Who may qualify
- Ages
- 15 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Asses the value of blood platelets to lymphocytes ratio and monocytes to lymphocytes ratio as predictors of response for the treatment of spontaneous bacterial peritonitis in cirrhotic patients.
Key inclusion criteria (2 listed)
- Cirrhotic patient with ascites.
- Un treated SBP
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| ascetic fluid studyascetic fluid study parameter in diagnosis of spontaneous bacterial peritpnitis | Diagnostic test | Cirrhotic Patients with Spontaneous Bacterial Peritonitis |
Primary outcome
Platelets to Lymphocytes Ratio and Monocytes to Lymphocytes Ratio as Predictors of Response to Treatment in Cirrhotic Patients with Spontaneous Bacterial Peritonitis
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Background: PubMed 30145857Song DS. [Spontaneous Bacterial Peritonitis]. Korean J Gastroenterol. 2018 Aug 25;72(2):56-63. doi: 10.4166/kjg.2018.72.2.56. Korean.
- Background: PubMed 36197150Abdel Hammed MR, El-Amien HA, Asham MN, Elgendy SG. Can platelets indices and blood neutrophil to lymphocyte ratio be used as predictors for diagnosis of spontaneous bacterial peritonitis in decompensated post hepatitis liver cirrhosis? Egypt J Immunol. 2022 Oct;29(4):12-24.
- Background: PubMed 21913982Chen TM, Lin CC, Huang PT, Wen CF. Neutrophil-to-lymphocyte ratio associated with mortality in early hepatocellular carcinoma patients after radiofrequency ablation. J Gastroenterol Hepatol. 2012 Mar;27(3):553-61. doi: 10.1111/j.1440-1746.2011.06910.x.
Related trials for Cirrhotic Patients With Spontaneous Bacterial Peritonitis
Not yet recruitingObservational study
Prediction of SBP in Cirrhotic Patients by Platlet Count, Na and AlBl Index.
Spontaneous Bacterial Peritonitis
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.
Asmaa N Mohamed 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 Patients With 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 2 inclusion and 10 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 9 May 2023. 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 Mohamed H Mohamed, resident (01019396460, mohamedhamed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelets to Lymphocytes Ratio and Monocytes to Lymphocytes Ratio as Predictors of Response to Treatment in Cirrhotic Patients with Spontaneous Bacterial Peritonitis (time frame: 19/4/2023 - 30/4/2024). 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 NCT05850858, which also lists 3 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 9 May 2023.