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Drainage of Tuberculous Pleural Effusions

This study has been completed.
Sponsor:
Information provided by:
Taipei Medical University Hospital
ClinicalTrials.gov Identifier:
NCT00524147
First received: August 31, 2007
Last updated: December 28, 2010
Last verified: December 2010
History of Changes
  Purpose

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 Intervention
Tuberculous Pleurisy
 Procedure: Pigtail drainage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Drainage of Tuberculous Pleural Effusions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Taipei Medical University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Chest radiography and pulmonary function testing with spirometry [ Time Frame: At discharge and at 2, 4, 6, and 12 months ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: October 2003
Study Completion Date: December 2006
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524147

Locations
Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University Hospital
Investigators
Principal Investigator: Chi-Li Chung, MD Department of Internal Medicine, Taipei Medical University Hospital
  More Information

No publications provided by Taipei Medical University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Chi-Li Chung, Department of Internal Medicine, Taipei Medical University Hospital
ClinicalTrials.gov Identifier: NCT00524147     History of Changes
Other Study ID Numbers: TMU92-AE1-B36
Study First Received: August 31, 2007
Last Updated: December 28, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University Hospital:
loculated pleural effusion
pigtail drainage
pleural effusion
pleural thickening
tuberculosis

Additional relevant MeSH terms:
Pleural Effusion
Pleurisy
Tuberculosis
Tuberculosis, Pleural
Pleural Diseases
Respiratory Tract Diseases
 Respiratory Tract Infections
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 19, 2013