NCT07419360 · Albany Medical College
DRAIN: DRainage in Acute Decompensated Heart faIlure With Pleural effusioNs
(DRAIN-IT)
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Albany, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 30, 2026 · Source of record for eligibility and locations