NCT03172013

Brief Summary

Spontaneous bacterial peritonitis (SBP) is an ascitic fluid infection in cirrhotic patients

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

2.6 years

First QC Date

May 27, 2017

Last Update Submit

May 30, 2017

Conditions

Cirrhosis, Liver

Outcome Measures

Primary Outcomes (1)

  • Number of patients with SBP and abnormal platelet indices

    Number of patients with SBP and abnormal platelet indices

    6 months

Study Arms (3)

Cirrhotic ascitic patients with SBP,

Cirrhotic ascitic patients with SBP,

Diagnostic Test: Platelet indices

cirrhotic ascitic patients without SBP,

cirrhotic ascitic patients without SBP,

Diagnostic Test: Platelet indices

Healthy volunteers

Healthy individuals

Diagnostic Test: Platelet indices

Interventions

Platelet indicesDIAGNOSTIC_TEST

MPV, PDW

Cirrhotic ascitic patients with SBP,Healthy volunteerscirrhotic ascitic patients without SBP,

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with cirrhotic ascites

You may qualify if:

  • Cirrhotic patients and ascites

You may not qualify if:

  • patients with ascites due to causes other than cirrhosis- immunocompromised patients,
  • patients with abnormal thrombocytes due to non-hepatic causes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Taher Eldemerdash, Professor

    Consultant of Hepatology - Tanta University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherief Abd-Elsalam, consultant

CONTACT

00201095159522Sheriefabdelsalam@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2017

First Posted

May 31, 2017

Study Start

May 11, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

EG(1)