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Evaluation and Outcome of Para-pneumonic Effusion

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ClinicalTrials.gov Identifier: NCT03480490
Recruitment Status : Not yet recruiting
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Walaa Rashad Ahmed Hassan, Assiut University

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.

Condition or disease Intervention/treatment
Pleural Effusion Diagnostic Test: Pleural fluid C-reactive protein

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.


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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation and Outcome of Para-pneumonic Effusion Among Children Attending Assuit University Pediatric Hospital
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : May 2020

Intervention Details:
  • Diagnostic Test: Pleural 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.



Primary Outcome Measures :
  1. cure rate from effusion [ Time Frame: baseline ]
    to evaluate the cure rate from para-pneumonic effusion among children



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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   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.
Criteria

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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480490


Contacts
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Contact: Walaa R Ahmed, MD 01015226240 walaarashad226240@gmail.com
Contact: Moustafa M El-Saied, PhD 01060779253 moustafa13@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Yasser F Abdel-raheim, PhD Assiut University

Additional Information:
Publications:
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Responsible Party: Walaa Rashad Ahmed Hassan, Principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03480490     History of Changes
Other Study ID Numbers: EOPE
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases