Angiogenic Cytokines and Fibrinolytic Activity in Parapneumonic Effusions

NCT01325454 | Unknown DMC

• 1 other identifier: TMUH-PARAPNEUMONIC STUDY
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pleural Effusion

Keywords

Pleural effusion; angiogenic cytokine; fibrinolytic activity

Outcome Measures

Primary Outcomes (1)

• Response to treatment including improvement in vital signs and chest radiography

  5 days after treatment within admission

Secondary Outcomes (1)

• Chest radiography and pulmonary function testing with spirometry.

  At discharge, and at 6 months

Study Arms (1)

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).

Device: pleural pigtail drainage

Interventions

pleural pigtail drainage DEVICE

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.

Also known as: chest drain, chest tube drainage, tube thoracostomy

Patients with parapneumonic effusions

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with pleural effusions of unknown causes admitted to Taipei Medical University Hospital were included.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Division of Pulmonary Medicine, Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Pleural effusions

MeSH Terms

Conditions

Pleural Effusion

Interventions

Chest Tubes

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Chi-Li Chung, MD, PhD

  Division of Pulmonary Medicine, Taipei Medical University, Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 29, 2011
• Study Start: January 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 29, 2011

Record last verified: 2011-03

Locations

TW (1)