- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03172013
Platelet Indices Could Predict Spontaneous Bacterial Peritonitis in Cirrhotic Ascitic Patients
May 30, 2017 updated by: Tanta University
Spontaneous bacterial peritonitis (SBP) is an ascitic fluid infection in cirrhotic patients
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Platelet indices can be utilized as a non-invasive predictor of SBP.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- Tanta university hospital
-
Principal Investigator:
- Taher Eldemerdash, Professor
-
Principal Investigator:
- Abdelrahman Kobtan, Consultant
-
Sub-Investigator:
- Amal Helmy, Professor
-
Sub-Investigator:
- Rania Kafoury, Physician
-
Sub-Investigator:
- Sherief Abd-Elsalam, Consultant
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with cirrhotic ascites
Description
Inclusion Criteria:
- Cirrhotic patients and ascites
Exclusion Criteria:
- patients with ascites due to causes other than cirrhosis- immunocompromised patients,
- patients with abnormal thrombocytes due to non-hepatic causes.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cirrhotic ascitic patients with SBP,
|
MPV, PDW
|
|
cirrhotic ascitic patients without SBP,
|
MPV, PDW
|
|
Healthy volunteers
Healthy individuals
|
MPV, PDW
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients with SBP and abnormal platelet indices
Time Frame: 6 months
|
Number of patients with SBP and abnormal platelet indices
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Taher Eldemerdash, Professor, Consultant of Hepatology - Tanta University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 11, 2017
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
May 27, 2017
First Submitted That Met QC Criteria
May 30, 2017
First Posted (Actual)
May 31, 2017
Study Record Updates
Last Update Posted (Actual)
May 31, 2017
Last Update Submitted That Met QC Criteria
May 30, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- eldemerdash
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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