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Not yet recruiting NCT07592520

Flush, Lyse, Operate

Phase IV Interventional Complicated Parapneumonic Effusion Empyema, Pleural

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intrapleural Saline with possible escalation to intraplerual alteplase and dornase..
Who it may be relevant to
Registry conditions: Complicated Parapneumonic Effusion, Empyema, Pleural. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • 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.]
Secondary outcome measures (5)
  • 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.]
  • 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.]
  • 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.]
  • Length of Hospital Stay [Time frame: From enrollment to discharge- up to 52 weeks.]
  • Mortality [Time frame: 30 days from enrollment: rate of documented death prior or up to 30 days.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Dartmouth-Hitchcock Medical Center — Hanover

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07592520 · STUDY02003106

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗