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DRAIN: DRainage in Acute Decompensated Heart faIlure With Pleural effusioNs

ConditionsCongestive Heart Failure(CHF)Pleural Effusion Due to Congestive Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlbany Medical College

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Thoracentesis

    Procedure/Surgery

    pleural fluid will be removed

Treatment groups

216 Participants
are divided into 2 treatment groups
Group A: InterventionalExperimental treatment 1 intervention
Group B: Medical TherapyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Dyspnea

Degree of dyspnea will be assessed as by using a validated 100 mm visual analog scale in participants of both groups. Dyspnea will be assessed using a 100 mm visual analog scale (VAS). The VAS consisted of a horizontal straight line with endpoints defining extreme limits, with the left end marked as "no trouble" (0 mm) and the right end as "very much trouble" (100 mm). A higher VAS score indicated more severe dyspnea. The minimal clinically important difference (MCID) was defined as ≥ 14 mm improvement on this 100 mm scale, adapted from the established 24-hour VAS dyspnea threshold for clinical practicality in our setting.

Time frame
30 days

Secondary outcomes

1

Proportion of patients achieved clinically significant decrease in mean VAS dyspnea score

Proportion of patients achieved clinically significant decrease in mean VAS dyspnea score over the first 30 days after the enrollment

Time frame
30 days
2

Bendopnea

Patient will be instructed to bend forward at the waist and aim to touch ankles and maintain this position for 60 seconds. Patient will inform the investigator as soon as the dyspnea occurs, and the time of onset of bendopnoea and degree of dyspnea will be recorded.

Time frame
5 days
3

Quality of life- KCCQ12

The investigators will use Kansas City Cardiomyopathy Questionnaire (KCCQ-12) to assess quality of life. This is based on 12 questions. Score ranges from 0 to 100. Higher score means better health.

Time frame
30 days
4

Hospital free day at day 90

Number of hospital-free days at day 90 post-randomization, defined as the total number of days alive and not hospitalized from the date of randomization to 90 days

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Albany Medical College

Lead sponsor

Source ClinicalTrials.gov
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