Cirrhosis, LiverNCT03172013
Platelet Indices Could Predict Spontaneous Bacterial Peritonitis in Cirrhotic Ascitic Patients
An observational study of Cirrhosis, Liver, run by Tanta University at 1 site in Egypt.
Trial summary
Spontaneous bacterial peritonitis (SBP) is an ascitic fluid infection in cirrhotic patients Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis, Liver
- What is being tested?
- Platelet indices
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 11 May 2017to Dec 2019
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with cirrhotic ascites
Who may be able to join
- Cirrhotic patients and ascites
Who cannot join
- patients with ascites due to causes other than cirrhosis- immunocompromised patients,
- patients with abnormal thrombocytes due to non-hepatic causes.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta university hospital
Cairo
Sherief Abd-Elsalam, 00201000040794, Sherif_tropical@yahoo.com
Taher Eldemerdash, Professor
About this study
Spontaneous bacterial peritonitis (SBP) is an ascitic fluid infection in cirrhotic patients
Read the detailed description
Platelet indices can be utilized as a non-invasive predictor of SBP.
- Conditions
- Cirrhosis, Liver
- Being tested
- Platelet indices
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet indicesDiagnostic test
MPV, PDW
| Study group | Role | What they receive |
|---|---|---|
| Cirrhotic ascitic patients with SBP, | Cirrhotic ascitic patients with SBP, Receives: Diagnostic Test: Platelet indices | |
| cirrhotic ascitic patients without SBP, | cirrhotic ascitic patients without SBP, Receives: Diagnostic Test: Platelet indices | |
| Healthy volunteers | Healthy individuals Receives: Diagnostic Test: Platelet indices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with SBP and abnormal platelet indices
Number of patients with SBP and abnormal platelet indices
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start11 May 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taher Eldemerdash, Professor, Principal investigator, Consultant of Hepatology - Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172013
- Sponsor's protocol ID
- eldemerdash
- Status last verified
- May 2017
- First submitted
- 27 May 2017
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Indices Could Predict Spontaneous Bacterial Peritonitis in Cirrhotic Ascitic Patients
- ClinicalTrials.gov ID
- NCT03172013
- Acronym / sponsor ID
- eldemerdash
- Conditions
- Cirrhosis, Liver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 11 May 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 31 May 2017 (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 an ascitic fluid infection in cirrhotic patients
Detailed description
Platelet indices can be utilized as a non-invasive predictor of SBP.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cirrhotic ascitic patients with SBP, | – | Diagnostic Test: Platelet indicesCirrhotic ascitic patients with SBP, |
| cirrhotic ascitic patients without SBP, | – | Diagnostic Test: Platelet indicescirrhotic ascitic patients without SBP, |
| Healthy volunteers | – | Diagnostic Test: Platelet indicesHealthy individuals |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cirrhotic ascites
Key inclusion criteria (1 listed)
- Cirrhotic patients and ascites
Key exclusion criteria (2 listed)
- patients with ascites due to causes other than cirrhosis- immunocompromised patients,
- patients with abnormal thrombocytes due to non-hepatic causes.
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 |
|---|---|---|
| Platelet indicesMPV, PDW | Diagnostic test | Cirrhotic ascitic patients with SBP,, Healthy volunteers, cirrhotic ascitic patients without SBP, |
Primary outcome
Number of patients with SBP and abnormal platelet indices
Time frame: 6 months
Number of patients with SBP and abnormal platelet indices
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Cirrhosis, Liver
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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.
Taher Eldemerdash, Professor principal investigator
Consultant of Hepatology - Tanta University
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 Cirrhosis, Liver, run by Tanta 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 2 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 31 May 2017. 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 Sherief Abd-Elsalam, consultant (00201095159522, Sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with SBP and abnormal platelet indices (time frame: 6 months). 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 31 May 2017.