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Therapeutic Thoracentesis for Patients With Congestive Heart Failure and Large Pleural Effusion

Primary Purpose

Congestive Heart Failure, Transudative Pleural Effusion

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Therapeutic thoracentesis
Sponsored by
Taipei Medical University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring congestive heart failure, thoracentesis, transudative pleural effusions

Eligibility Criteria

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

Inclusion Criteria:

  • transudative pleural effusion established by the criteria of Light
  • the effusion occupying at least half of one hemithorax shown on chest radiography
  • symptoms of respiratory distress
  • diagnosis of congestive heart failure

Exclusion Criteria:

  • severe uncontrolled coagulopathy
  • unstable hemodynamics
  • diagnosis of liver cirrhosis, chronic obstructive pulmonary disease,asthma and/or any parenchymal lung disease, such as pneumonia, fibrosis or malignancy.

Sites / Locations

  • Taipei Medical University Hospital

Outcomes

Primary Outcome Measures

Vital signs, minute volume, expiratory tidal volume, dynamic compliance, arterial oxygen saturation and arterial blood gases, the volume of pleural fluid removed, and the changes in pleural liquid pressure and pleural space elastance

Secondary Outcome Measures

Full Information

First Posted
February 25, 2008
Last Updated
December 28, 2010
Sponsor
Taipei Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00629538
Brief Title
Therapeutic Thoracentesis for Patients With Congestive Heart Failure and Large Pleural Effusion
Official Title
Effect of Therapeutic Thoracentesis on Cardiopulmonary Function in Patients With Congestive Heart Failure Complicated With Large to Massive Pleural Effusion
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Taipei Medical University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Transudative pleural effusions are a common manifestation of patients with congestive heart failure. Severe dyspnea and respiratory failure may develop in those with large effusions, which in general show poor response to medical treatment. Therapeutic thoracenteses (TT) may be indicated in these patients and can produce marked relief of symptoms. However, the underlying effect of TT on gas exchange and respiratory mechanics in theses patients remains unclear. The researchers' hypothesis is that,TT may improve arterial oxygenation and respiratory mechanics in patients with congestive heart failure complicated by large pleural effusions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Transudative Pleural Effusion
Keywords
congestive heart failure, thoracentesis, transudative pleural effusions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Therapeutic thoracentesis
Intervention Description
Thoracentesis was performed with drainage of 500 ml of pleural fluid first and every 200 ml thereafter until pleural pressure was lower than -20 cm H2O, chest discomfort developed, or no more pleural fluid could be removed.
Primary Outcome Measure Information:
Title
Vital signs, minute volume, expiratory tidal volume, dynamic compliance, arterial oxygen saturation and arterial blood gases, the volume of pleural fluid removed, and the changes in pleural liquid pressure and pleural space elastance
Time Frame
15 minutes after therapeutic thoracentesis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: transudative pleural effusion established by the criteria of Light the effusion occupying at least half of one hemithorax shown on chest radiography symptoms of respiratory distress diagnosis of congestive heart failure Exclusion Criteria: severe uncontrolled coagulopathy unstable hemodynamics diagnosis of liver cirrhosis, chronic obstructive pulmonary disease,asthma and/or any parenchymal lung disease, such as pneumonia, fibrosis or malignancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi-Li Chung, MD, PhD
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
ZIP/Postal Code
110
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
20646242
Citation
Chen WL, Chung CL, Hsiao SH, Chang SC. Pleural space elastance and changes in oxygenation after therapeutic thoracentesis in ventilated patients with heart failure and transudative pleural effusions. Respirology. 2010 Aug;15(6):1001-8. doi: 10.1111/j.1440-1843.2010.01812.x. Epub 2010 Jul 20.
Results Reference
derived

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Therapeutic Thoracentesis for Patients With Congestive Heart Failure and Large Pleural Effusion

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