Spontaneous Bacterial PeritonitisNCT04775420
MPV and NLR as Predictors of SBP Diagnosis
An observational study of Spontaneous Bacterial Peritonitis, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of the study is to investigate the clinical utility of mean platelet volume (MPV) and neutrophil to lymphocyte ratio (NLR) as diagnostic markers for spontaneous bacterial peritonitis (SBP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Bacterial Peritonitis
- What is being tested?
- Measurement of mean platelet volume (MPV) and blood neutrophil to lymphocyte ratio (NLR)
- How many people
- 332 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 30 Apr 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ascites due to decompensated liver cirrhosis admitted at the inpatient section of Tropical Medicine and Gastroenterology Department, Sohag University Hospital.
Who may be able to join
- Decompensated liver cirrhosis ascetic patients.
Who cannot join
- Immunocompromised patients.
- Patients who had received antibiotics before hospital admission.
- Patients on anticoagulant medications, NSAIDs, or oral contraceptive drugs.
- Patients with heart failure, diabetes mellitus, hypertension, hyperlipidemia, peripheral vascular disease, hematological disorders, and neoplastic disorders and patients with clinically overt hypothyroidism or hyperthyroidism or with clinically and laboratory-evident autoimmune diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mean Platelet Volume (MPV) and Neutrophil to Lymphocyte Ratio (NLR) as Predictors of Spontaneous Bacterial Peritonitis in Cirrhotic Patients
The aim of the study is to investigate the clinical utility of mean platelet volume (MPV) and neutrophil to lymphocyte ratio (NLR) as diagnostic markers for spontaneous bacterial peritonitis (SBP).
- Conditions
- Spontaneous Bacterial Peritonitis
- Being tested
- Measurement of mean platelet volume (MPV) and blood neutrophil to lymphocyte ratio (NLR)
- Keywords
- Spontaneous bacterial peritonitis, Mean platelet volume, Neutrophil to lymphocyte ratio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of mean platelet volume (MPV) and blood neutrophil to lymphocyte ratio (NLR)Diagnostic test
MPV and NLR are easily accessible and inexpensive tests
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Ascetic patients without spontaneous bacterial peritonitis Receives: Diagnostic Test: Measurement of mean platelet volume (MPV) and blood neutrophil to lymphocyte ratio (NLR) | |
| Group 2 | Ascetic patients with spontaneous bacterial peritonitis Receives: Diagnostic Test: Measurement of mean platelet volume (MPV) and blood neutrophil to lymphocyte ratio (NLR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The utility of MPV as non-invasive predictor of SBP
It will be measured from CBC
Measured: 1 year
The utility of NLR as non-invasive predictor of SBP
It will be measured from CBC
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 posted1 Mar 2021
- Study start1 Apr 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abudeif Abdelaal, MD, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775420
- Sponsor's protocol ID
- Soh-Med-21-02-22
- Status last verified
- Jan 2023
- First submitted
- 25 Feb 2021
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mean Platelet Volume (MPV) and Neutrophil to Lymphocyte Ratio (NLR) as Predictors of Spontaneous Bacterial Peritonitis in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT04775420
- Acronym / sponsor ID
- Soh-Med-21-02-22
- Conditions
- Spontaneous Bacterial Peritonitis
- Keywords
- Spontaneous bacterial peritonitis, Mean platelet volume, Neutrophil to lymphocyte ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 1 Mar 2021 (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.
The aim of the study is to investigate the clinical utility of mean platelet volume (MPV) and neutrophil to lymphocyte ratio (NLR) as diagnostic markers for spontaneous bacterial peritonitis (SBP).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Measurement of mean platelet volume (MPV) and blood neutrophil to lymphocyte ratio (NLR)Ascetic patients without spontaneous bacterial peritonitis |
| Group 2 | – | Diagnostic Test: Measurement of mean platelet volume (MPV) and blood neutrophil to lymphocyte ratio (NLR)Ascetic patients with spontaneous bacterial peritonitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ascites due to decompensated liver cirrhosis admitted at the inpatient section of Tropical Medicine and Gastroenterology Department, Sohag University Hospital.
Key inclusion criteria (1 listed)
- Decompensated liver cirrhosis ascetic patients.
Key exclusion criteria (4 listed)
- Immunocompromised patients.
- Patients who had received antibiotics before hospital admission.
- Patients on anticoagulant medications, NSAIDs, or oral contraceptive drugs.
- Patients with heart failure, diabetes mellitus, hypertension, hyperlipidemia, peripheral vascular disease, hematological disorders, and neoplastic disorders and patients with clinically overt hypothyroidism or hyperthyroidism or with clinically and laboratory-evident autoimmune diseases.
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 |
|---|---|---|
| Measurement of mean platelet volume (MPV) and blood neutrophil to lymphocyte ratio (NLR)MPV and NLR are easily accessible and inexpensive tests | Diagnostic test | Group 1, Group 2 |
Primary outcome
The utility of MPV as non-invasive predictor of SBP
Time frame: 1 year
It will be measured from CBC
The utility of NLR as non-invasive predictor of SBP
Time frame: 1 year
It will be measured from CBC
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 4 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: finished, as of the sponsor's last update on 23 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The utility of MPV as non-invasive predictor of SBP (time frame: 1 year). The study lists 2 primary outcomes in all. 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 23 Jan 2023.