NCT03480490

Brief Summary

Pleural effusion is the accumulation of excess fluid in the pleural cavity, which results in disturbance of the equilibrium between vascular hydrostatic and oncotic pressures. The underlying causes of pleural effusion include pleural inflammation or infection, congestive heart failure, lymphatic drainage blockage and malignancy.A parapneumonic effusion is a pleural effusion associated with lung infection. Early in the course of parapneumonic effusion, the pleura becomes inflamed with leakage of cellular elements, protein, and fluid into the pleural space, forming the effusion. Subsequent bacterial invasion results in a frank empyema, the presence of which often requires thoracentesis.

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
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

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

March 19, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

March 19, 2018

Last Update Submit

March 26, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • cure rate from effusion

    to evaluate the cure rate from para-pneumonic effusion among children

    baseline

Interventions

C-reactive protein is an acute phase protein that is synthesized by the liver in response to various stimuli. The pleural fluid c-reactive protein levels are likely to reflect the serum levels because the presence of c-reactive protein in the pleural fluid may be due to increased diffusion from the blood as a result of inflamed capillary leakage. Pleural c-reactive protein has been proposed as a specific biomarker for the differential diagnosis of pleural effusions and reportedly exhibits higher sensitivity and specificity than serum c-reactive protein. c-reactive protein can be considered a good candidate due to its 1000-fold elevation in response to infection and the positive correlation between the serum and pleural c-reactive protein levels. Pleural fluid c-reactive protein level was significantly higher in exudates than that in transudative effusion.

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This study was conducted on patients with para-pneumonic effusion who were admitted to the Assiut University Pediatrics Hospital in the period between january 2019 and january 2020.

You may qualify if:

  • This study will be conducted upon patients(male and females),from 1 month to 18 years with para-pneumonic effusion at assuit university pediatric hospital from January to june 2019 after taking consents.

You may not qualify if:

  • age: \>18 years old congenital heart disease lymphatic drainage blockage post traumatic pleural effusion renal diseases hepatic diseases neoplastic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Adeoye PO, Johnson WR, Desalu OO, Ofoegbu CP, Fawibe AE, Salami AK, Fadeyi A, Akin-Dosumu AA, Rasheedat IM; Ilorin Pleural Effusion Study Group. Etiology, clinical characteristics, and management of pleural effusion in Ilorin, Nigeria. Niger Med J. 2017 Mar-Apr;58(2):76-80. doi: 10.4103/0300-1652.219349.

    PMID: 29269986BACKGROUND

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Yasser F Abdel-raheim, PhD

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Moustafa M El-Saied, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

March 19, 2018

First Posted

March 29, 2018

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

May 1, 2020

Last Updated

March 29, 2018

Record last verified: 2018-03