An interventional study of tunneled pleural catheter in Pleural Effusions, Chronic, Congestive Heart Failure and Shortness of Breath, sponsored by University of California, Los Angeles. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-05.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Supportive care
Congestive heart disease (CHF) can frequently cause transudative pleural effusions, some of which do not completely resolve with diuretics alone. These effusions can cause significant morbidity, leading to ongoing dyspnea and hypoxia, resulting in additional office and hospital visits. TREAT-CHF is a randomized trial studying tunneled pleural catheter (TPC) versus standard medical management for the treatment recurrent symptomatic pleural effusions secondary to CHF that are refractory to maximal medical therapy. TREAT-CHF will study whether the addition of a TPC can improve quality of life and minimize health care utilization over the one year following insertion.
TREAT-CHF is a randomized trial studying tunneled pleural catheter (TPC) versus standard medical management for the treatment recurrent symptomatic pleural effusions secondary to CHF that are refractory to maximal medical therapy. All trial participants will be adults with congestive heart failure (CHF) already managed with maximal medical therapy, as determined by their cardiologist or primary physician. Patients will demonstrate recurrent transudative or pseudoexudative pleural effusions caused solely by CHF that have not been controlled with medical therapy alone. Included patients must also show documented subjective symptomatic relief with thoracentesis.
Patients will be randomized to the intervention group or control group. The intervention group will receive a tunneled pleural catheter (TPC) in addition to their current medical treatment. The control group will continue with medical therapy by their referring physician and serial thoracenteses when clinically appropriate. Patients will then be followed over the course of once year after enrollment. The TPC will be drained daily for symptomatic relief. Several outcomes, including quality of life based on periodic self-survey and healthcare utilization determined by chart review (emergency room visits and hospital stays), will be studied. Adverse outcomes of TPC insertion and sequelae of frequent pleural space drainage will be documented.
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Exclusion Criteria:
This group will receive placement of a tunneled pleural catheter to drain their recurrent, chronic, and symptomatic pleural effusion in addition to their usual medication therapy.
Device: tunneled pleural catheter
The control group will continue with medical therapy by their referring physician and serial thoracenteses when clinically appropriate.
Placement of a tunneled pleural catheter through the chest wall into the pleural space to drain the patient's chronic pleural effusion. The catheter is an indwelling device that will be drained from home three times per week by nursing care, the patient, or patient's family.
Also known as: pleurx catheter placement
Change in quality of life scores from baseline as measured by the Minnesota Living with Heart Failure Questionnaire
Quality of life will be measured by the Minnesota Living with Heart Failure Questionnaire at four time points
Time frame: Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months)
Incidence of hospitalizations and emergency room encounters
Measurement of all significant health care visits, including hospitalizations and emergency room encounters
Time frame: 1 year post-enrollment
All cause mortality
All cause mortality
Time frame: 1 year post-enrollment
New York Heath Association (NYHA) functional class
NYHA functional class: I, III, III, or IV
Time frame: Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months)
Incidence of pleural procedures
By convention, the intervention group will have one pleural procedure (TPC placement). Any additional thoracenteses, video-assisted thoracoscopic surgery, or chest tubes on either side of the chest will be documented for both groups. Removal of or manipulation of TPC will not be recorded as an additional pleural procedure.
Time frame: 1 year post-enrollment
Incidence of pleural space or chest wall infection
Pleural space infection is defined as a positive pleural fluid culture. Chest wall infection will be defined clinically, based on the presence of cellulitis surrounding the catheter or catheter tract, or pus draining from the catheter insertion site.
Time frame: 1 year post-enrollment
Incidence of hemothorax
Hemothorax is defined as a pleural hematocrit or red blood cell count (RBC) exceeding 50% that of the serum hematocrit or RBC count.
Time frame: 1 year post-enrollment
Incidence of trapped lung, loculated pleural effusion, and pneumothorax
Trapped lung is defined as a lung that does not expand after pleural fluid drainage leaving a pneumothorax ex-vacuo or hydropneumothorax. Pneumothorax and loculated pleural effusion will be determined based on classic imaging characteristics.
Time frame: 1 year post-enrollment
Incidence of pleurodesis
Incidence of pleurodesis over the one year after enrollment will be measured. Pleurodesis is defined as apposition of the parietal and visceral pleural such: (i) that the subject drains less than 10cc on three serial drainages, (ii) there is resolution of the pleural effusion on both chest x-ray (CXR) and chest ultrasound, (iii) the TPC is removed, and (iv) the pleural effusion does not accumulate after TPC removal as evidence by CXR and chest ultrasound.
Time frame: 1 year post-enrollment
Time to pleurodesis among those who achieved pleurodesis
The number of days from enrollment (control group) or TPC placement (intervention group) to pleurodesis among those who achieved pleurodesis will be recorded. Pleurodesis is defined as apposition of the parietal and visceral pleural such: (i) that the subject drains less than 10cc on three serial drainages, (ii) there is resolution of the pleural effusion on both chest x-ray (CXR) and chest ultrasound, (iii) the TPC is removed, and (iv) the pleural effusion does not accumulate after TPC removal as evidence by CXR and chest ultrasound.
Time frame: 1 year post-enrollment
Change from baseline serum albumin
serum albumin levels
Time frame: Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months)
Change from baseline serum creatinine
serum creatinine levels
Time frame: Change from baseline at 3 time points over the year of follow up (3, 6, and 12 months)
Rate of hemodialysis initiation
We will record patients who develop worsening renal failure, necessitating initiation of hemodialysis
Time frame: 1 year post-enrollment
Plan to share: No
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University of California, Los Angeles