Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434324
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-23
Brief Title:
Pleural Space Saline Irrigation in Addition to Standard Intrapleural Thrombolytic Therapy in EmpyemaComplicated Parapneumonic Effusion
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Study to Evaluate the Efficacy of Pleural Space Saline Irrigation in Addition to Standard Intrapleural Thrombolytic Therapy in the Management of EmpyemaComplicated Parapneumonic Effusion
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if there is any benefit in adding saline irrigation through a chest tube to the standard course of treatment for people diagnosed or suspected of having a pleural space infection
Detailed Description:
Pleural space infections portend considerable morbidity and require procedural and sometimes surgical intervention in the context of prolonged hospital stays median length of stay has been reported as 14-19 days for definitive management Key aspects of management include pleural space evacuation and appropriate antimicrobial therapy The antimicrobial regimen is initiated intravenously and is often transitioned to an oral regimen as guided by clinical improvement radiographic improvement and microbiologic studies though conventional bacterial cultures remain negative in as many as 40 of cases of pleural space infection There is variability in antimicrobial duration though this is typically continued for at least 3 weeks The MIST 2 trial investigated the role of intrapleural tissue plasminogen activator t-PA and dornase DNase in the management of pleural space infections noting that disrupting septations and reducing pleural fluid viscosity were necessary steps to achieve successful drainage in in-vitro studies MIST 2 demonstrated that a combination of intrapleural t-PA and DNase improved pleural space evacuation on serial chest x-ray and reduced the frequency of surgical referral and hospital length of stay
Saline irrigation of the pleural space has been proposed to reduce stasis and dilute bacteria cytokines and coagulation factors which induce pleural space organization The Pleural Irrigation Trial was a pilot study evaluating the role of 250 cc 09 sodium chloride irrigation three times daily for 3 days in comparison to standard care which included maintaining thoracostomy tubes on suction and flushing with 30 cc three times daily Saline irrigation led to a 323 reduction in pleural fluid volume as assessed by computed tomography in comparison to 153 in the standard care arm Fewer patients in the irrigation group were referred for surgery OR 71
To our knowledge the efficacy of intrapleural saline irrigation in addition to fibrinolytic therapy has not been studied in comparison to fibrinolytic therapy alone The Mayo Clinic Interventional Pulmonary practice in Rochester MN intends to study this in the context of the inpatient pleural service the team that is routinely consulted for patients with proven or suspected pleural space infections This team routinely places and manages ultrasound-guided locking-loop thoracostomy tubes and additionally manages patients with thoracostomy tubes placed by intensivists surgeons and interventional radiologists when consulted Our team intends to recruit hospitalized patients that meet the inclusionexclusion criteria of the study Those that provide informed consent to participate in the study will be randomized to usual care versus intrapleural saline irrigation usual care
Saline irrigation of the pleural space has been proposed to reduce stasis and dilute bacteria cytokines and coagulation factors which induce pleural space organization The Pleural Irrigation Trial was a pilot study evaluating the role of 250 cc 09 sodium chloride irrigation three times daily for 3 days in comparison to standard care which included maintaining thoracostomy tubes on suction and flushing with 30 cc three times daily Saline irrigation led to a 323 reduction in pleural fluid volume as assessed by computed tomography in comparison to 153 in the standard care arm Fewer patients in the irrigation group were referred for surgery OR 71
To our knowledge the efficacy of intrapleural saline irrigation in addition to fibrinolytic therapy has not been studied in comparison to fibrinolytic therapy alone The Mayo Clinic Interventional Pulmonary practice in Rochester MN intends to study this in the context of the inpatient pleural service the team that is routinely consulted for patients with proven or suspected pleural space infections This team routinely places and manages ultrasound-guided locking-loop thoracostomy tubes and additionally manages patients with thoracostomy tubes placed by intensivists surgeons and interventional radiologists when consulted Our team intends to recruit hospitalized patients that meet the inclusionexclusion criteria of the study Those that provide informed consent to participate in the study will be randomized to usual care versus intrapleural saline irrigation usual care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HT9425-24-C-0010 | OTHER_GRANT | US Dept of Defense | None |