Pleural EffusionNCT03480490
Evaluation and Outcome of Para-pneumonic Effusion
An observational study of Pleural Effusion, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Pleural fluid C-reactive protein
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- age: >18 years old congenital heart disease lymphatic drainage blockage post traumatic pleural effusion renal diseases hepatic diseases neoplastic diseases
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation and Outcome of Para-pneumonic Effusion Among Children Attending Assuit University Pediatric Hospital
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.
- Conditions
- Pleural Effusion
- Being tested
- Pleural fluid C-reactive protein
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleural fluid C-reactive proteinDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate from effusion
to evaluate the cure rate from para-pneumonic effusion among children
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Rashad Ahmed Hassan, Assiut University
- Investigators
- Yasser F Abdel-raheim, PhD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480490
- Sponsor's protocol ID
- EOPE
- Status last verified
- Mar 2018
- First submitted
- 19 Mar 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Outcome of Para-pneumonic Effusion Among Children Attending Assuit University Pediatric Hospital
- ClinicalTrials.gov ID
- NCT03480490
- Acronym / sponsor ID
- EOPE
- Conditions
- Pleural Effusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- age: >18 years old congenital heart disease lymphatic drainage blockage post traumatic pleural effusion renal diseases hepatic diseases neoplastic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pleural fluid C-reactive proteinC-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. | Diagnostic test | – |
Primary outcome
cure rate from effusion
Time frame: baseline
to evaluate the cure rate from para-pneumonic effusion among children
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Background: PubMed 29269986Adeoye 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasser F Abdel-raheim, PhD principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Effusion, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Walaa R Ahmed, MD (01015226240, walaarashad226240@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cure rate from effusion (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03480490, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018; AzTrials last refreshed its copy on 6 Nov 2026.