ClinicalTrials.gg
Status unknownNCT03480490Updated Mar 29, 2018

Evaluation and Outcome of Para-pneumonic Effusion

An observational study in Pleural Effusion, sponsored by Assiut University. Status unknown. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2018-03-29.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
25
Ages
1 Month to 18 Years
Sex
All
01

Study 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.

Read the detailed description

A delay in the diagnosis and initiation of proper therapy for infectious effusions leads to increases in the complication rate. These delays are more common in patients with coexisting heart failure or malignancy.In fact, pleural effusion manifestations are alerting signs of pain, dyspnea, and the signs of respiratory failure due to compression of the lungs.

Other signs include tachypnea, decreased percussion, and decreased respiratory sounds. The most common cause of pleural effusion in children is parapneumonic effusion or purulent empyema.

Although the prevalence of pleural effusion is high in children, its mortality rate is low . According to the studies performed in the United States, parapneumonic effusion is known as the most common underlying cause of pleural effusion in 50% to 70% of the cases . Congenital heart diseases include 5-15% of the causes and malignancies are the rare reasons of effusion.

In general, effusions may be transudate or exudate and examination of the pleural fluid is necessary to differentiate them. Exudate is confirmed by the presence of at least one of the following criteria; pleural effusion concentration higher than half of the serum protein level, pleural effusion protein level more than 3 g/dL, pleural effusion lactate dehydrogenase higher than 200 U, pH lower than 7.2, and glucose lower than 40.

C-reactive protein is an acute phase protein that is synthesized by the liver in response to various stimuli.The induction of C-reactive protein synthesis in the liver is triggered by the production of Interleukin-6 and Tumor Necrosis Factor-alpha by local pleural cells.

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-reacive 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.

02

Conditions studied

  • Pleural Effusion

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03

In context

Pleural Effusion

335 studies on the registry are indexed under Pleural Effusion; 63 are open to participants now.

This study's planned enrollment of 25 is below the median of 104 across 105 observational studies indexed under Pleural Effusion.

Browse Pleural Effusion studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • age: >18 years old congenital heart disease lymphatic drainage blockage post traumatic pleural effusion renal diseases hepatic diseases neoplastic diseases
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
25 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testPleural fluid C-reactive protein

    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.

06

What researchers measure

Primary outcomes

  1. cure rate from effusion

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

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 29269986 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2019; primary completion for Jan 2020, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2018
First posted
Mar 29, 2018
StartEst.
Jan 1, 2019
Primary completionEst.
Jan 1, 2020
CompletionEst.
May 2020
Last update
Mar 29, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03480490
Lead sponsor
Assiut University
Responsible party
Walaa Rashad Ahmed Hassan (Principle investigator, Assiut University) — Principal investigator
First posted
Mar 29, 2018
Start date
Jan 1, 2019 (estimated)
Primary completion
Jan 1, 2020 (estimated)
Completion
May 2020 (estimated)
Last update
Mar 29, 2018

Study contacts

Walaa R Ahmed, MD
Contact
walaarashad226240@gmail.com
01015226240
Moustafa M El-Saied, PhD
Contact
moustafa13@yahoo.com
01060779253
Yasser F Abdel-raheim, PhD
principal investigator · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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