Drainage of Tuberculous Pleural Effusions

• ClinicalTrials.gov Identifier: NCT00524147
• Recruitment Status: Completed
• First Posted: September 3, 2007
• Last Update Posted: December 30, 2010
• Sponsor: Taipei Medical University Hospital
• Information provided by: Taipei Medical University Hospital

Tracking Information

• First Submitted Date: August 31, 2007
• First Posted Date: September 3, 2007
• Last Update Posted Date: December 30, 2010
• Study Start Date: October 2003
• Actual Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 31, 2007): 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 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: August 31, 2007): Chest radiography and pulmonary function testing with spirometry [ Time Frame: At discharge and at 2, 4, 6, and 12 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Drainage of Tuberculous Pleural Effusions
• Official Title: Drainage of Tuberculous Pleural Effusions
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Tuberculous Pleurisy
• Intervention: Procedure: Pigtail drainage
• Study Arms: Not Provided
• Publications *: Chung CL, Chen CH, Yeh CY, Sheu JR, Chang SC. Early effective drainage in the treatment of loculated tuberculous pleurisy. Eur Respir J. 2008 Jun;31(6):1261-7. doi: 10.1183/09031936.00122207. Epub 2008 Jan 23.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 31, 2007): 64
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2006
• Actual Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT00524147
• Other Study ID Numbers: TMU92-AE1-B36
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Chi-Li Chung, Department of Internal Medicine, Taipei Medical University Hospital
• Study Sponsor: Taipei Medical University Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Chi-Li Chung, MD; Department of Internal Medicine, Taipei Medical University Hospital

• PRS Account: Taipei Medical University Hospital
• Verification Date: December 2010