Drainage of Tuberculous Pleural Effusions

Tuberculous Pleurisy Clinical Trial

Official title:

Drainage of Tuberculous Pleural Effusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00524147
• Other study ID #: TMU92-AE1-B36
• Status: Completed
• Phase: N/A
• First received: August 31, 2007
• Last updated: December 28, 2010
• Start date: October 2003
• Est. completion date: December 2006

Study information

• Verified date: December 2010
• Source: Taipei Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

Tuberculous (TB) pleurisy can cause clinical symptoms and pleural fibrosis with resultant residual pleural thickening (RPT). Therapeutic thoracentesis or initial complete drainage in addition to anti-TB drugs have been tried to rapidly relieve dyspnea caused by effusion and to decrease the occurrence of RPT. However, contradictory results are reported without clear reasons. The researchers' hypothesis is that, in addition to anti-TB medications, early effective evacuation of inflammatory exudates with or without fibrinolytic agents may hasten resolution of pleural effusion, reduce the occurrence of RPT and finally improve long-term functional outcome in patients with TB pleurisy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2006
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of tuberculous pleurisy

Exclusion Criteria:

• History of invasive procedures directed into the pleural cavity

• Recent severe trauma, hemorrhage, or stroke; bleeding disorder or anticoagulant therapy

• Use of streptokinase in the previous 2 years

• Lack of clinical symptoms caused by effusions

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pleural Effusion
• Tuberculosis
• Tuberculosis, Pleural
• Tuberculous Pleurisy

Intervention

Procedure:
• Pigtail drainage

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chest radiography, daily monitoring of the volume of fluid drained, the time needed for resolution of fever and dyspnea, and total amounts of fluid drained, and the length of chest drainage and hospitalization		baseline, daily after treatment within admission	No
Secondary	Chest radiography and pulmonary function testing with spirometry		At discharge and at 2, 4, 6, and 12 months	No