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Trial record 2 of 2 for:    B36

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

Tracking Information
First Submitted Date  ICMJE August 31, 2007
First Posted Date  ICMJE September 3, 2007
Last Update Posted Date December 30, 2010
Study Start Date  ICMJE October 2003
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Drainage of Tuberculous Pleural Effusions
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tuberculous Pleurisy
Intervention  ICMJE Procedure: Pigtail drainage
Study Arms  ICMJE 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2007)
64
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00524147
Other Study ID Numbers  ICMJE TMU92-AE1-B36
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chi-Li Chung, Department of Internal Medicine, Taipei Medical University Hospital
Study Sponsor  ICMJE Taipei Medical University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chi-Li Chung, MD Department of Internal Medicine, Taipei Medical University Hospital
PRS Account Taipei Medical University Hospital
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP