DRAIN: DRainage in Acute Decompensated Heart faIlure With Pleural effusioNs

Official title

Role of Therapeutic Thoracentesis in Hospitalized Patients With Acute Decompensated Heart Failure: Randomized Controlled Trial

Overview

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

Detailed description

Congestive heart failure (CHF) is the most common cause of pleural effusions.The presence of clinically significant pleural effusions in hospitalized patients with CHF has been associated with increased hospital length of stay and mortality.The treatment of CHF-related pleural effusion (CHF-PE) typically involves heart failure management such as diuresis. The role of therapeutic thoracentesis in managing heart failure-related effusions is not well established. There is only one randomized controlled trial that assessed the effect of therapeutic thoracentesis in patients with reduced left ventricular ejection fraction (≤45%) and a sizable pleural effusion. This study showed that upfront large volume thoracentesis in addition to medical therapy did not result in improved outcomes, including median days alive out of the hospital over 90 days, hospital length of stay, mortality, or quality of life. However, this trial excluded patients with heart failure with preserved ejection fraction (HFpEF). Few studies show that HFpEF is a more common and prevalent cause of heart failure-related pleural effusion as compared to those with heart failure with reduced ejection fraction (HFrEF).

In this randomized controlled trial, the investigators will compare the clinical outcomes of hospitalized patients with acute decompensated heart failure and pleural effusion who receive therapeutic thoracentesis in addition to medical therapy as compared to the no thoracentesis group.

Primary objective of this study is to assess the effect of upfront therapeutic thoracentesis in addition to the medical therapy in hospitalized patients with acute decompensated heart failure and moderate to large effusion on degree of dyspnea relief as measured by VAS score

Secondary objectives are to examine the effect of thoracentesis on secondary outcomes such as index hospital length of stay, 90-day hospital free survival, quality of life, hospital readmission rate at 90 days and complications related to thoracentesis.

Interventions

• Procedure Thoracentesis
  pleural fluid will be removed

Primary outcome measures

• Dyspnea [Time frame: 30 days]

Secondary outcome measures (6)

• Proportion of patients achieved clinically significant decrease in mean VAS dyspnea score [Time frame: 30 days]
• Bendopnea [Time frame: 5 days]
• Quality of life- KCCQ12 [Time frame: 30 days]
• Hospital free day at day 90 [Time frame: 90 days]
• All-cause mortality [Time frame: 90 days]
• Adverse events [Time frame: upto 30 days]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Albany Medical Center — Albany

Identifiers

NCT: NCT07419360 · AMC IRB# 7327 · No funding

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗