Flush, Lyse, Operate

NCT07592520 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY02003106
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Complicated Parapneumonic Effusion; Empyema, Pleural

Outcome Measures

Primary Outcomes (1)

• Time to chest tube removal

  measuring the length of time from chest tube insertion to removal

  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.

Secondary Outcomes (5)

• Need for escalation to fibrinolytics

  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.

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

  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.

• Rate of hemothorax.

  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.

• Length of Hospital Stay

  From enrollment to discharge- up to 52 weeks.

• Mortality

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

Study Arms (1)

Intraplerual Saline

OTHER

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.

Drug: Intrapleural Saline with possible escalation to intraplerual alteplase and dornase.

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.

Also known as: normal saline, alteplase, dornase alfa

Intraplerual Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Hanover, New Hampshire, 03756, United States

Location

Related Publications (6)

• Hassan M, Rizk R, Essam H, Abouelnour A. Validation of equations for pleural effusion volume estimation by ultrasonography. J Ultrasound. 2017 Oct 27;20(4):267-271. doi: 10.1007/s40477-017-0266-1. eCollection 2017 Dec.

  PMID: 29204230 BACKGROUND

• Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.

  PMID: 23961782 BACKGROUND

• Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.

  PMID: 26092476 BACKGROUND

• Hooper CE, Edey AJ, Wallis A, Clive AO, Morley A, White P, Medford AR, Harvey JE, Darby M, Zahan-Evans N, Maskell NA. Pleural irrigation trial (PIT): a randomised controlled trial of pleural irrigation with normal saline versus standard care in patients with pleural infection. Eur Respir J. 2015 Aug;46(2):456-63. doi: 10.1183/09031936.00147214. Epub 2015 May 28.

  PMID: 26022948 BACKGROUND

• Rahman NM, Maskell NA, West A, Teoh R, Arnold A, Mackinlay C, Peckham D, Davies CW, Ali N, Kinnear W, Bentley A, Kahan BC, Wrightson JM, Davies HE, Hooper CE, Lee YC, Hedley EL, Crosthwaite N, Choo L, Helm EJ, Gleeson FV, Nunn AJ, Davies RJ. Intrapleural use of tissue plasminogen activator and DNase in pleural infection. N Engl J Med. 2011 Aug 11;365(6):518-26. doi: 10.1056/NEJMoa1012740.

  PMID: 21830966 BACKGROUND

• Maskell NA, Davies CW, Nunn AJ, Hedley EL, Gleeson FV, Miller R, Gabe R, Rees GL, Peto TE, Woodhead MA, Lane DJ, Darbyshire JH, Davies RJ; First Multicenter Intrapleural Sepsis Trial (MIST1) Group. U.K. Controlled trial of intrapleural streptokinase for pleural infection. N Engl J Med. 2005 Mar 3;352(9):865-74. doi: 10.1056/NEJMoa042473.

  PMID: 15745977 BACKGROUND

MeSH Terms

Conditions

Empyema, Pleural

Interventions

Saline Solution; Tissue Plasminogen Activator; dornase alfa

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonary and Critical Care Fellow

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: May 18, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

US (1)