DRAIN: DRainage in Acute Decompensated Heart faIlure With Pleural effusioNs
Recruiting · NCT07419360 · Interventional (participants receive a specific treatment) · Lead sponsor: Albany Medical College
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this study is to assess if removal of fluid around the lungs (pleural effusion) by a routine procedure called as thoracentesis is helpful to decrease shortness of breath in hospitalized patients with congestive heart failure and have pleural effusion. Researchers will compare thoracentesis with medical therapy to medical therapy alone to see if one treatment is superior to the other treatment in relieving shortness of breath. Participants will : 1. Receive medical therapy with or without thoracentesis 2. Record degree of shortness of breath and quality of life before and after the intervention using predefined standard scales. 3. Telephonic call for 15- 30 mins at day 14 and 30 after enrollment to assess shortness of breath and quality of life
Who can take part
Inclusion criteria
- Adult patients age \>18 years and.
- Clinical diagnosis of acute decompensated heart failure with at least one clinical sign of volume overload (e.g., peripheral edema, pleural effusion, or ascites) and
- Assessment of left ventricular ejection fraction (LVEF) by echocardiography performed during the time of index hospitalization or within 3 months prior to enrollment and
- Serum NT-proBNP level of \>1000 pg/ml or Serum BNP\>250 pg/ml at the time of enrollment and
- Radiographic evidence of moderate to large pleural effusion, defined as pleural fluid occupying more than 1/3rd of the hemithorax on chest X-ray.
Exclusion criteria
- Clinical indication for diagnostic thoracentesis - Presence of fever, clinical signs of infection, or atypical pleural effusion for CHF (unilateral left-sided effusion, findings suggestive of malignancy, infection, or alternative etiologies) or.
- Loculated pleural effusion - Evidence of loculated pleural effusion on thoracic ultrasound, as defined as the presence of septations or complex homogenous echogenic fluid (see Imaging Assessment section) or.
- Clinical indication for therapeutic thoracentesis - Presence of massive pleural effusion with acute respiratory failure requiring positive pressure ventilation, high-flow oxygen therapy (\>15 liters per minute of flow), or tension hydrothorax (massive effusion with mediastinal shift and hemodynamic compromise) or.
- Contraindication to thoracentesis, uncontrolled bleeding diathesis, or irreversible INR \> 2.0 and platelet count \<50,000 or.
- Patient with mechanical mitral valve, where anticoagulation cannot be safely held or.
- Pleural procedure, such as but not limited to thoracentesis, chest tube placement, or thoracoscopy, within 3 months prior to enrollment or.
- Cardiac or thoracic surgery within 3 months prior to enrollment or.
- Requirement for chronic renal replacement therapy, such as hemodialysis or peritoneal dialysis or.
- Pregnancy or
- Inability or unwillingness to provide informed consent, or current incarceration (prisoners).
Where it is running
1 location listed across 1 US state.
- Albany Medical Center - Albany, New York, United States