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NCT Number: NCT07592520

Flush, Lyse, Operate

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.

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Key information

Conditions

Complicated Parapneumonic Effusion Empyema Empyema, Pleural Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Diseases Respiratory Tract Diseases Respiratory Tract Infections Suppuration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dartmouth-Hitchcock Medical Center

Hanover, New Hampshire, 03756, United States

Location contact

Adele E Soutar, MD

CONTACT

[email protected]

603-650-5000

David Feller-Kopman, MD

SUB_INVESTIGATOR

Jimmy Wang, MD

SUB_INVESTIGATOR

About this study

Patients who require a chest tube for complicated parapneumonic effusion or empyema who meet inclusion criteria and consent, will be enrolled. An ultrasound measurement of the original effusions prior to chest tube placement will be obtained then chest tube insertion will follow as well as an additional US measurement once placed. After appropriate positioning is confirmed, there will be instillation of intrapleural saline and will be administered every 8 hours for a total of 3 days. After completion of the intrapleural saline course, the effusion will be remeasured by ultrasound. Should the effusions fail to reduce by 75% or significant septations remain, the patient will then be escalated to intrapleural tPA/DNase which will be administered every 12 hours for 3 days. After the completed course of tPA/DNase, a US will be performed, and if significant fluid remains, >50% of the original effusion or septations remain, Thoracic Surgery consultation will be placed for discussion of VATs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18+
  • Complicated Parapneumonic Effusion or Empyema Requiring Thoracostomy
  • Are able to personally or have a designated medical decision maker provide consent

Exclusion criteria

  • Age < 18 years
  • Have received any intrapleural medications prior to enrolment via current chest tube
  • Have a contraindication to tPA/DNase:
  • Anticoagulation
  • Active hemorrhage
  • Allergy to tPA/DNase
  • Pregnancy
  • Are unable to personally or do not have a designated medical decision maker provide consent

Treatment and study plan

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.

Other names: normal saline, alteplase, dornase alfa

Primary outcomes

  1. 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.

    measuring the length of time from chest tube insertion to removal

Secondary outcomes

  1. Need for escalation to fibrinolytics

    Time frame: From enrollment to chest tube removal- 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.

    Rate of patients requiring intraplerual tPA/DNAse after completion of intrapleural saline

  2. Need for escalation to Video-assisted thoracic surgery (VATS)

    Time frame: From enrollment to chest tube removal- up to 7 days. Once chest tube is placed, it will take 3 days for saline course to be completed and 3 days for intrapleural fibrinolytics, therefore VATs determined after, about 7 days.

    Evaluation fo patients who require Video-assisted thoracic surgery (VATS) after completion of intraplerual saline and tPA/DNAse

  3. Rate of hemothorax.

    Time frame: From enrollment to chest tube removal- 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.

    Evaluating number of patients who develop a hemothorax

  4. Length of Hospital Stay

    Time frame: From enrollment to discharge- up to 52 weeks.

    Quantifying the length of hospital stay for all patients enrolled

  5. Mortality

    Time frame: 30 days from enrollment: rate of documented death prior or up to 30 days.

    Rate of 30 day all cause mortally

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

Flush, Lyse, Operate: A Pilot Trial of Step-Wise Escalation for Pleural Infection: FLO Trial

Acronym: FLO

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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