Pleural EffusionNCT01325454
Angiogenic Cytokines and Fibrinolytic Activity in Parapneumonic Effusions
An observational study of Pleural Effusion, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial summary
Angiogenesis is a key process in the formation of exudative pleural effusions. Fluid loculation is common in parapneumonic effusion and is associated with depressed pleural fibrinolytic activity and poor clinical outcome. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- pleural pigtail drainage
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2008to Dec 2011
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pleural effusions of unknown causes admitted to Taipei Medical University Hospital were included.
Who may be able to join
- Patients with pleural effusions of unknown causes admitted to Taipei Medical University Hospital were included if parapneumonic effusion was diagnosed as one associated with pneumonia according to the criteria of the American Thoracic Society (ie, patients with newly acquired respiratory symptoms, fever, and abnormal breath sounds, plus a new lung infiltrate seen on a chest radiograph).
Who cannot join
- History of chest trauma or invasive procedures directed into the pleural cavity; bleeding disorder or anticoagulant therapy
- Use of streptokinase in the previous 2 years; and likely survival less than 6 months.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Division of Pulmonary Medicine, Taipei Medical University Hospital
Taipei, 110
Chi-Li Chung, MD, PhD, 886-2-27372181 ext. 3903, d102092009@tmu.edu.tw
Chi-Li Chung, MD, PhD
About this study
Angiogenesis is a key process in the formation of exudative pleural effusions. Fluid loculation is common in parapneumonic effusion and is associated with depressed pleural fibrinolytic activity and poor clinical outcome. However, the relationship between angiogenic cytokines and fibrinolytic activity in the pleural space remains unclear. The researchers's hypothesis is that the levels of angiogenic cytokines were increased and associated with decreased fibrinolytic activity in parapneumonic effusions which may contribute to fibrin deposition and fluid loculation in the pleural space.
Read the detailed description
Formation of parapneumonic effusions (PPE) involves increased pleural vascular permeability induced by the contiguous pneumonia. It has been demonstrated that exposure of pleural mesothelial cells to bacteria or lipopolysaccharide (LPS) leads to increased release of angiogenic factors, including vascular endothelial growth factor (VEGF) and interleukin (IL)-8, which induce vascular hyperpermeability, fluid exudation, and neutrophil influx into the pleural space, and may play a pivotal role in development of PPE. With persistent inflammation and angiogenesis, amplified vascular and mesothelial permeability leads to increased plasma extravasation, activation of the coagulation cascade, and repression of fibrinolytic activity within the pleural cavity, which contribute to the development of a ''complicated'' PPE, manifested with fibrin deposition and pleural fluid loculation. Fibrin turnover in the pleural cavity is greatly affected by fibrinolytic activity mediated by plasmin, which is regulated mainly by the equilibrium between plasminogen activators (PAs) and plasminogen activator inhibitors (PAIs).VEGF induces vascular hyperpermeability and may facilitate the genesis of fibrin gel in PPE. Previous studies reported that VEGF plays a role in the modulation of tPA and PAI-1, and that anti-VEGF antibody attenuates pleurodesis induced by transforming growth factor-β2. These findings suggest that VEGF may be involved in the regulation of fibrin turnover, fluid loculation and tissue fibrosis in the pleural space. Enhanced procoagulant and depressed fibrinolytic activities have been observed in PPE. However, the relationship between angiogenic cytokines and fibrinolytic activity in PPE remains unclear.
- Conditions
- Pleural Effusion
- Being tested
- pleural pigtail drainage
- Keywords
- Pleural effusion, angiogenic cytokine, fibrinolytic activity
- 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 pigtail drainageDevice
Also called chest drain, chest tube drainage, tube thoracostomy
With the guidance of chest US, 50 ml of pleural fluid was collected using a standard thoracentesis technique immediately or within 24 hr after hospitalization. When pleural effusion was multi-loculated, the fluid was aspirated from the largest loculus. Routine analyses of pleural fluid for total leukocytes, cell differentials of leukocytes, pH value, and levels of protein, glucose and LDH were performed in addition to cytological and microbiologic examination of pleural fluid.The rest of pleural fluid samples were mixed with 3.8 % sodium citrate in a 9:1 ratio of pleural fluid to citrate. The sodium citrate-mixed pleural fluid specimens were immersed in ice immediately and then centrifuged at 2,500 g for 10 minutes. The cell-free supernatants of pleural fluid were frozen at -70℃ immediately after centrifuge for later measurements. The commercially available enzyme-linked immunosorbent assay kits were used to measure the effusion levels of VEGF, IL-8 , tPA and PAI-1.
| Study group | Role | What they receive |
|---|---|---|
| Patients with parapneumonic effusions | Patients with pleural effusions of unknown causes admitted to Taipei Medical University Hospital were included if parapneumonic effusion was diagnosed as one associated with pneumonia according to the criteria of the American Thoracic Society (ie, patients with newly acquired respiratory symptoms, fever, and abnormal breath sounds, plus a new lung infiltrate seen on a chest radiograph). Receives: Device: pleural pigtail drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment including improvement in vital signs and chest radiography
Measured: 5 days after treatment within admission
Secondary outcomes (1)
Chest radiography and pulmonary function testing with spirometry.
Measured: At discharge, and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startJan 2008
- Primary completionJun 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- Chi-Li Chung, MD, PhD, Principal investigator, Division of Pulmonary Medicine, Taipei Medical University, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325454
- Sponsor's protocol ID
- TMUH-PARAPNEUMONIC STUDY
- Status last verified
- Mar 2011
- First submitted
- 23 Mar 2011
- Last updated
- 29 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiogenic Cytokines and Fibrinolytic Activity in Parapneumonic Effusions
- ClinicalTrials.gov ID
- NCT01325454
- Acronym / sponsor ID
- TMUH-PARAPNEUMONIC STUDY
- Conditions
- Pleural Effusion
- Keywords
- Pleural effusion, angiogenic cytokine, fibrinolytic activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jan 2008
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 29 Mar 2011 (estimated)
- 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.
Angiogenesis is a key process in the formation of exudative pleural effusions. Fluid loculation is common in parapneumonic effusion and is associated with depressed pleural fibrinolytic activity and poor clinical outcome. However, the relationship between angiogenic cytokines and fibrinolytic activity in the pleural space remains unclear. The researchers's hypothesis is that the levels of angiogenic cytokines were increased and associated with decreased fibrinolytic activity in parapneumonic effusions which may contribute to fibrin deposition and fluid loculation in the pleural space.
Detailed description
Formation of parapneumonic effusions (PPE) involves increased pleural vascular permeability induced by the contiguous pneumonia. It has been demonstrated that exposure of pleural mesothelial cells to bacteria or lipopolysaccharide (LPS) leads to increased release of angiogenic factors, including vascular endothelial growth factor (VEGF) and interleukin (IL)-8, which induce vascular hyperpermeability, fluid exudation, and neutrophil influx into the pleural space, and may play a pivotal role in development of PPE. With persistent inflammation and angiogenesis, amplified vascular and mesothelial permeability leads to increased plasma extravasation, activation of the coagulation cascade, and repression of fibrinolytic activity within the pleural cavity, which contribute to the development of a ''complicated'' PPE, manifested with fibrin deposition and pleural fluid loculation. Fibrin turnover in the pleural cavity is greatly affected by fibrinolytic activity mediated by plasmin, which is regulated mainly by the equilibrium between plasminogen activators (PAs) and plasminogen activator inhibitors (PAIs).VEGF induces vascular hyperpermeability and may facilitate the genesis of fibrin gel in PPE. Previous studies reported that VEGF plays a role in the modulation of tPA and PAI-1, and that anti-VEGF antibody attenuates pleurodesis induced by transforming growth factor-β2. These findings suggest that VEGF may be involved in the regulation of fibrin turnover, fluid loculation and tissue fibrosis in the pleural space. Enhanced procoagulant and depressed fibrinolytic activities have been observed in PPE. However, the relationship between angiogenic cytokines and fibrinolytic activity in PPE remains unclear.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with parapneumonic effusions | – | Device: pleural pigtail drainagePatients with pleural effusions of unknown causes admitted to Taipei Medical University Hospital were included if parapneumonic effusion was diagnosed as one associated with pneumonia according to the criteria of the American Thoracic Society (ie, patients with newly acquired respiratory symptoms, fever, and abnormal breath sounds, plus a new lung infiltrate seen on a chest radiograph). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pleural effusions of unknown causes admitted to Taipei Medical University Hospital were included.
Key inclusion criteria (1 listed)
- Patients with pleural effusions of unknown causes admitted to Taipei Medical University Hospital were included if parapneumonic effusion was diagnosed as one associated with pneumonia according to the criteria of the American Thoracic Society (ie, patients with newly acquired respiratory symptoms, fever, and abnormal breath sounds, plus a new lung infiltrate seen on a chest radiograph).
Key exclusion criteria (2 listed)
- History of chest trauma or invasive procedures directed into the pleural cavity; bleeding disorder or anticoagulant therapy
- Use of streptokinase in the previous 2 years; and likely survival less than 6 months.
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 pigtail drainageAlso: chest drain, chest tube drainage, tube thoracostomyWith the guidance of chest US, 50 ml of pleural fluid was collected using a standard thoracentesis technique immediately or within 24 hr after hospitalization. When pleural effusion was multi-loculated, the fluid was aspirated from the largest loculus. Routine analyses of pleural fluid for total leukocytes, cell differentials of leukocytes, pH value, and levels of protein, glucose and LDH were performed in addition to cytological and microbiologic examination of pleural fluid.The rest of pleural fluid samples were mixed with 3.8 % sodium citrate in a 9:1 ratio of pleural fluid to citrate. The sodium citrate-mixed pleural fluid specimens were immersed in ice immediately and then centrifuged at 2,500 g for 10 minutes. The cell-free supernatants of pleural fluid were frozen at -70℃ immediately after centrifuge for later measurements. The commercially available enzyme-linked immunosorbent assay kits were used to measure the effusion levels of VEGF, IL-8 , tPA and PAI-1. | Device | Patients with parapneumonic effusions |
Primary outcome
Response to treatment including improvement in vital signs and chest radiography
Time frame: 5 days after treatment within admission
1 secondary outcome
Chest radiography and pulmonary function testing with spirometry.
Time frame: At discharge, and at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2011.
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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.
Division of Pulmonary Medicine, Taipei Medical University Hospital
Taipei, Taiwan
Chi-Li Chung, MD, PhD principal investigator
Division of Pulmonary Medicine, Taipei Medical University, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Effusion, run by Taipei Medical University Hospital at 1 site in Taiwan.
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 2 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 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to treatment including improvement in vital signs and chest radiography (time frame: 5 days after treatment within admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2011; AzTrials last refreshed its copy on 8 Nov 2026.