NCT05696054

Brief Summary

This study aims at evaluating the diagnostic accuracy of serum procalcitonin, PEC index, modified Wehmeyer, and Mansoura scoring systems for SBP in cirrhotic patients with ascites

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

January 1, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

January 1, 2023

Last Update Submit

January 23, 2023

Conditions

Spontaneous Bacterial Peritonitis

Outcome Measures

Primary Outcomes (3)

  • PEC index

    procalcitoin × (ESR + CRP)

    five months

  • Modified Wehmeyer score

    a score is calculated based on age, CRP level, and platelet count using a scale from 0 to 5 as follows: age \>60 years: 1 point. platelet count \<100,000/mL: 1 point CRP between 13.5 and30 mg/L: 1 point CRP between 30 and 60 mg/L: 2 points CRP above 60 mg/L: 3 points

    five months

  • Mansoura score

    score is calculated based on age, mean platelets volume, neutrophil lymphocytic ratio, and CRP using a scale of 0 to 5 as follows: Age ≥55 years: 1 point MPV ≥8.5 fl: 1 point NLR≥2.5: 1 point CRP≥40 mg/l: 2 points

    five months

Study Arms (2)

SBP group

Patients diagnosed as spontaneous bacterial peritonitis based on ascitic fluid study.

non-SBP group

Patients without spontaneous bacterial peritonitis based on ascitic fluid study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to Tropical Medicine and Gastroenterology Department

You may qualify if:

  • cirrhotic patients with ascites

You may not qualify if:

  • Infections other than SBP.
  • malignancy.
  • Antibiotic therapy before hospital admission.
  • Chemotherapy or radiotherapy within 1 month before admission.
  • Pancreatic diseases.
  • contraindication to paracentesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample Ascitic fluid

Central Study Contacts

Amira Maher, MD

CONTACT

00201006789652amiramaher@med.sohag.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Tropical Medicine and Gastroenterology

Study Record Dates

First Submitted

January 1, 2023

First Posted

January 25, 2023

Study Start

February 15, 2023

Primary Completion

July 15, 2023

Study Completion

September 15, 2023

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share