Objective:
To evaluate the efficacy and safety of pleural saline irrigation as an adjunct therapy in
patients with retained pleural infection, comparing it with the standard of care
(antibiotics, chest tube placement, and lytics).
Study Design:
This is a prospective, two-arm pilot trial to be conducted at Beth Israel Deaconess
Medical Center. The study will involve two groups: one receiving standard care and the
other receiving pleural saline irrigation in addition to standard care. Patients will be
assigned to one of the two study arms (standard care vs. standard care + saline
irrigation) using block randomization to ensure balanced group sizes.
Interventions:
Control Group (Standard Care):
Patients will receive the current standard of care, which includes antibiotics, chest
tube placement, and intrapleural tPA/DNase therapy based on the criteria outlined above.
Intervention Group (Standard Care + Saline Irrigation):
In addition to the standard care, patients in this group will receive pleural saline
irrigation through the chest tube immediately after IPFT. The amount of saline will be
determined by free-flow saline infusion up to 250 mL. This maneuver will be repeated each
time IPFT is administered, based on the treating physician's criteria.
Outcomes:
Primary Endpoint:
The primary outcome is the reduction in pleural effusion volume, measured with CT
(volumetry) and US (Balik formula), with efficacy defined as a 10% or greater improvement
compared to standard care alone. Success will be determined by a ≥10% additional
reduction in pleural effusion volume compared to regular interventions.
Secondary Endpoints:
Rate of pleural infection resolution based on clinical (fever), radiographic (ultrasound
and CT signs of complicated pleural effusion), and laboratory (inflammatory markers)
data.
Chest tube duration. Duration of hospital stay. Complications related to the
interventions. Pain associated with the interventions. Need for surgery. Overall
mortality.
Data Collection and Variables:
A range of variables will be collected to assess both primary and secondary outcomes.
Primary outcome measures will focus on the percentage reduction in pleural effusion
volume, assessed through chest ultrasound or CT scan at baseline and during follow-up.
Secondary outcomes include adverse events related to the intervention, such as
hypothermia, chest discomfort, and fluid overload. The incidence of pleural
infection-related complications, recurrence of infection, and the need for further
pleural interventions, such as thoracentesis or chest tube placement, will be monitored.
Chest tube duration, fever duration, leukocytosis, neutrophil count, and blood culture
results will be evaluated to track infection resolution and patient recovery.
Subgroup analysis will be performed based on pleural fluid volume and characteristics
(pH, glucose, LDH), antibiotic duration, and follow-up imaging results, both at the end
of therapy and 3-6 weeks later. Other intervention-related variables, such as the amount
and frequency of saline irrigation, chest tube size, intrapleural tPA/DNase doses, and
the total volume of fluid drained, will also be collected to further assess the
intervention's efficacy and safety.