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

This study has been completed.
Sponsor:
Information provided by:
Taipei Medical University Hospital
ClinicalTrials.gov Identifier:
NCT00629538
First received: February 25, 2008
Last updated: December 28, 2010
Last verified: December 2010
History of Changes
  Purpose

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.


Condition Intervention
Congestive Heart Failure
Transudative Pleural Effusion
 Procedure: Therapeutic thoracentesis

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Therapeutic Thoracentesis on Cardiopulmonary Function in Patients With Congestive Heart Failure Complicated With Large to Massive Pleural Effusion

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Taipei Medical University Hospital:

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 [ Time Frame: 15 minutes after therapeutic thoracentesis ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: March 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Therapeutic thoracentesis
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629538

Locations
Taiwan
Taipei Medical University Hospital
Taipei, Taiwan, 110
Sponsors and Collaborators
Taipei Medical University Hospital
Investigators
Principal Investigator: Chi-Li Chung, MD, PhD Department of Internal Medicine, Taipei Medical University Hospital
  More Information

No publications provided by Taipei Medical University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Chung, Chi-Li/Chest physician of Department of Internal Medicine, Taipei Medical University Hospital
ClinicalTrials.gov Identifier: NCT00629538     History of Changes
Other Study ID Numbers: TMUHIRB20070304
Study First Received: February 25, 2008
Last Updated: December 28, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University Hospital:
congestive heart failure
thoracentesis
transudative pleural effusions

Additional relevant MeSH terms:
Heart Failure
Hydrothorax
Pleural Effusion
Heart Diseases
 Cardiovascular Diseases
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013