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Drainage of Tuberculous Pleural Effusions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00524147
Recruitment Status : Completed
First Posted : September 3, 2007
Last Update Posted : December 30, 2010
Information provided by:
Taipei Medical University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Tuberculous Pleurisy Procedure: Pigtail drainage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Drainage of Tuberculous Pleural Effusions
Study Start Date : October 2003
Actual Primary Completion Date : October 2005
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Primary Outcome Measures :
  1. 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 [ Time Frame: baseline, daily after treatment within admission ]

Secondary Outcome Measures :
  1. Chest radiography and pulmonary function testing with spirometry [ Time Frame: At discharge and at 2, 4, 6, and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00524147

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Taipei Medical University Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University Hospital
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Principal Investigator: Chi-Li Chung, MD Department of Internal Medicine, Taipei Medical University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Chi-Li Chung, Department of Internal Medicine, Taipei Medical University Hospital Identifier: NCT00524147    
Other Study ID Numbers: TMU92-AE1-B36
First Posted: September 3, 2007    Key Record Dates
Last Update Posted: December 30, 2010
Last Verified: December 2010
Keywords provided by Taipei Medical University Hospital:
loculated pleural effusion
pigtail drainage
pleural effusion
pleural thickening
Additional relevant MeSH terms:
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Tuberculosis, Pleural
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Respiratory Tract Infections