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Drainage of Tuberculous Pleural Effusions

Primary Purpose

Tuberculous Pleurisy

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Pigtail drainage

About this trial

This is an interventional treatment trial for Tuberculous Pleurisy focused on measuring loculated pleural effusion, pigtail drainage, pleural effusion, pleural thickening, tuberculosis

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Taipei Medical University Hospital

Outcomes

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

Secondary Outcome Measures

Chest radiography and pulmonary function testing with spirometry

Full Information

NCT ID

NCT00524147

First Posted

August 31, 2007

Last Updated

December 28, 2010

Sponsor

Taipei Medical University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00524147

Brief Title

Drainage of Tuberculous Pleural Effusions

Official Title

Drainage of Tuberculous Pleural Effusions

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

October 2005 (Actual)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Taipei Medical University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tuberculous Pleurisy

Keywords

loculated pleural effusion, pigtail drainage, pleural effusion, pleural thickening, tuberculosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Pigtail drainage

Primary Outcome Measure Information:

Title

Time Frame

baseline, daily after treatment within admission

Secondary Outcome Measure Information:

Title

Chest radiography and pulmonary function testing with spirometry

Time Frame

At discharge and at 2, 4, 6, and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chi-Li Chung, MD

Organizational Affiliation

Department of Internal Medicine, Taipei Medical University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Taipei Medical University Hospital

City

Taipei

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

18216051

Citation

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.

Results Reference

derived

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Drainage of Tuberculous Pleural Effusions

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