Drainage of Tuberculous Pleural Effusions | NCT00524147

Studies
Drainage of Tuberculous Pleural Effusions

NCT00524147

Sponsor

Taipei Medical University Hospital

Status

Completed

Last Update Posted

Dec 30, 2010Estimated

Enrollment

64Actual

Phase

Not Applicable

Conditions

Tuberculous Pleurisy

Interventions

Pigtail drainage

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2003

Primary Completion Date

Oct 2005Actual

Completion Date

Dec 2006Actual

First Submitted Date

Aug 31, 2007

First Submission Date that Met QC Criteria

Aug 31, 2007

First Posted Date

Sep 3, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2010

Last Update Posted Date

Dec 30, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Name	Type	Description	Arm Group Labels	Other Names
Pigtail drainage	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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		baseline, daily after treatment within admission

Secondary Outcomes

Measure	Description	Time Frame
Chest radiography and pulmonary function testing with spirometry		At discharge and at 2, 4, 6, and 12 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chi-Li Chung, MD	Department of Internal Medicine, Taipei Medical University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Medical University Hospital		Taipei			Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18216051	Derived	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.

ID	Term
D014396	Tuberculosis, Pleural
D010996	Pleural Effusion
D014376	Tuberculosis

ID	Term
D000092225	Tuberculosis, Extrapulmonary
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections