Flush, Lyse, Operate

Conditions

• Complicated Parapneumonic Effusion
• Empyema, Pleural

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Intrapleural Saline with possible escalation to intraplerual alteplase and dornase. — DRUG
  Though intraplerual alteplase/ dornase alfa and normal saline have been established method to reduce complicated pleural infection sizes and rate of surgical interventions, with tPA/DNAse being the gold standards, there has not been a study comparing the two head to head. This trial's purpose is to function as pilot study as a foundation for a potential noninferiorrity trail comparing the two.

Study Details

The goal of this observational study is to learn if saline results in improvement for patients with infection of their plerual space. The main question it aims to answer is: What is the time to chest tube removal? Do these patients after need to escalate to fibrinolytics? Do these patients after need to escalate to surgery? Participants will: * Receive receive saline into their pleural space through an existing chest tube * If they fail to improve, which will be determined by fluid size after treatment or signs of persistent infection, they will receive fibrynolytics through an existing chest tube * If they fail to improve, which will be determined by fluid size after treatment or signs of persistent infection, they will be referred to surgery.

Key Dates

Start date

Apr 30, 2026

Status verified

May 2026

Primary completion

Apr 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: Intraplerual Saline
  All patients will be in a single arm and escalated from intraplerual saline to tPA/DNAse followed by surgery as warranted based on protocol criteria.

Primary Outcome Measure

Time to chest tube removal [ Time Frame: From enrollment to removal- estimated up to 7 days. Once chest tube is placed, it will take 3 days for saline course to be completed and, if escalated, 3 days for intrapleural fibrinolytics, therefore may not be removed until after 7 days. ]

Locations (1)

Find similar trials in Hanover, NH

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