- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03480490
Evaluation and Outcome of Para-pneumonic Effusion
Evaluation and Outcome of Para-pneumonic Effusion Among Children Attending Assuit University Pediatric Hospital
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cure rate from effusion
Time Frame: baseline
|
to evaluate the cure rate from para-pneumonic effusion among children
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yasser F Abdel-raheim, PhD, Assiut University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EOPE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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