Therapeutic Thoracentesis for Patients With Congestive Heart Failure and Large Pleural Effusion - Full Text View

Sponsored by:	Taipei Medical University Hospital
Information provided by:	Taipei Medical University Hospital
ClinicalTrials.gov Identifier:	NCT00629538

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

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

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

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 ]

Enrollment:	14
Study Start Date:	March 2007
Study Completion Date:	May 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

Responsible Party:	Taipei Medical University Hospital ( Chung, Chi-Li/Chest physician of Department of Internal Medicine )
Study ID Numbers:	TMUHIRB20070304
Study First Received:	February 25, 2008
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00629538 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by Taipei Medical University Hospital:

congestive heart failure
thoracentesis
transudative pleural effusions

Study placed in the following topic categories:

Pleural Effusion
Heart Failure
Heart Diseases
Respiratory Tract Diseases
Pleural Diseases

Additional relevant MeSH terms:

Pleural Effusion
Heart Failure
Heart Diseases

Respiratory Tract Diseases
Pleural Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009